Original article 1447
Quality assessment of endoscopic retrograde cholangiopancreatography: results of a running nationwide Austrian benchmarking project after 5 years of implementation Christine Kaprala, Andrea Mu¨hlbergerb, Friedrich Wewalkaa, Christine Dullerb, Peter Knoflachc, Florian Schreiberd and For the Working Groups ‘Quality Assurance’ and ‘Endoscopy’ of the Austrian Society of Gastroenterology and Hepatology (OeGGH). Objective Endoscopic retrograde cholangiopancreatography (ERCP) has a high risk of various complications. The aim of this study is to report the main ERCP outcome, that means complications and success rates, on the basis of the pooled data of a national continuous quality assessment program. Methods This study is an uncontrolled prospective survey and provides data from both academic and communitybased endoscopy centers with varying case volumes and expertise. Data were collected within a nationwide voluntary ERCP benchmarking project that was initiated by the Austrian Society of Gastroenterology and Hepatology. Results In total, 42 sites participated in this program for varying periods (1 month up to 5 years) and reported 13 513 procedures within 5 years. The overall complication rate in nonselected patients was 10.1%. Post-ERCP pancreatitis occurred in 4.2%, bleeding in 3.6% (0.4% clinically relevant), cholangitis in 1.4%, cardiopulmonary complications in 1.2%, perforation in 0.6%, and procedurerelated deaths in 0.1% of procedures. The overall therapeutic and diagnostic target was achieved in 80.3% (2009–2011) to 84.8% (2006/2007) of procedures.
Introduction Since its introduction in 1968, endoscopic retrograde cholangiopancreatography (ERCP) has evolved from a diagnostic tool into a sophisticated therapeutic endoscopic intervention [1]. It has become a technically demanding examination associated with procedurerelated risks and complications including death [2–12]. Experience and appropriate training of endoscopists play a major role in patient outcome and patient safety [2,3,13]. The Western society is increasingly focusing on quality outcomes in medicine. At the same time, healthcare providers are faced with financial cuts and with the rapid development of medical techniques and devices, becoming more expensive. Several endoscopic societies have proposed quality indicators for ERCP to aid in the recognition of ERCP examinations c 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins 0954-691X
The desired duct was visualized in 90.7% and cannulated in 88.8% of procedures. Conclusion The aim of the running benchmarking project in ERCP is to improve patient care in Austria. The survey reflects the general effectiveness and safety of ERCP. The overall complication and success rates are consistent with the available literature data. It sets an example as a benchmarking program that might result in international or even pan-European projects in high-risk endoscopic procedures. Eur J Gastroenterol Hepatol 24:1447–1454
c 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins. European Journal of Gastroenterology & Hepatology 2012, 24:1447–1454 Keywords: benchmarking, complications, endoscopic retrograde cholangiopancreatography, quality assessment, success rates a 4th Medical Department, Elisabethinen Hospital, bDepartment of Applied Statistics, Faculty of Social and Economic Sciences, Johannes Kepler University, Linz, c1st Medical Department, Clinical Centre Wels-Grieskirchen, Wels and d Department of Internal Medicine, Division of Gastroenterology and Hepatology, Medical University of Graz, Austria
Correspondence to Christine Kapral, MD, PhD, 4th Medical Department, Elisabethinen Hospital, Fadingerstraße 1, A-4020 Linz, Austria Tel: + 43 732 7676 4477; fax: + 43 732 7676 4426; e-mail:
[email protected] Received 3 May 2012 Accepted 17 July 2012
of high quality [14–20]. Such indicators allow the development of quality insurance programs. It is not clear whether all services where ERCP is provided to patients follow the recommendations in terms of quality indicators. Furthermore, large studies documenting quality outcomes in community practice and in academic centers simultaneously are lacking. In 2006, 140 sites and in 2010, 118 sites were registered in Austria to perform ERCP, with up to an estimated 15 000 procedures/year. The Austrian Society of Gastroenterology and Hepatology (OeGGH) initiated a nationwide project for voluntary benchmarking of ERCP in 2006 [13]. The ongoing quality program was interrupted in 2008 for an update and resumed subsequently in 2009. At the end of a calendar year, each participating center DOI: 10.1097/MEG.0b013e3283583c6f
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1448 European Journal of Gastroenterology & Hepatology 2012, Vol 24 No 12
receives a confidential detailed report on its individual results in comparison with the averaged results of the pooled benchmark data from all participating sites. Even the individual performance of each endoscopist is available if requested. This project presents a special service free of charge for the participants to enable all gastrointestinal endoscopists to share the program. Each center receives an annual diploma by the OeGGH for its participation. The project provides an overview of success and complication rates in prospectively collected multicenter data from both academic and community-based endoscopy services with varying case volumes and expertise. The aim of this study is to report the main ERCP outcomes from the pooled data of a national survey for quality assessment of ERCP after 5 years of its implementation. It is supposed to set an example as a benchmarking program in high-risk endoscopic procedures.
Details and quality indicators covered by the updated online questionnaire
Table 1
Identification
Participating center and endoscopist
Patient-related characteristics
Sex Age Significant comorbidities Anticoagulation Peri-interventional antibiotics Date of ERCP Anatomic aberration Pancreatitis prophylaxis Reaching the papilla Difficult biliary cannulation Technique of cannulation Achievement of the therapeutic target: entirely, partially, or not achieved Visualization and cannulation of the desired duct Sphincterotomy and technique of sphincterotomy Stent removal and insertion (kind and location) Extraction of stones Other interventions (dilation, nasobiliary tube, papillectomy, etc.) Bleeding Perforation Post-ERCP pancreatitis Post-ERCP cholangitis Cardiopulmonary complications Before ERCP and 24–48 h after ERCP Final diagnosis and correspondence with indication for ERCP
General information on the examination
Success and target
Interventions
Complications
Methods Project and collection of data
This study is an uncontrolled prospective survey on success and complication rates in ERCP. The OeGGH developed a questionnaire on ERCP and initiated a quality program in 2006. In 2008, the project was interrupted for an update and resumed in a revised version in 2009. In 2010, pancreatitis prophylaxis, technique of cannulation, and difficult biliary cannulation were added to the questionnaire. Detailed applied benchmarks of the latest version are shown in Table 1. They were selected from recognized quality indicators for ERCP provided by the European and the American Society of Gastrointestinal Endoscopy [14,16–21]. The participating centers are urged to report on every performed ERCP for best possible data completeness. The IFAS (Department of Applied Statistics, Faculty of Social and Economic Sciences, Johannes Kepler University, Linz, Austria) conducted the online questionnaire for data recording. Separate codes for each procedure are provided by the IFAS to access a multiple-choice input mask. Participating endoscopists remain anonymous, and patient data as well as centers are encoded pseudonymously. Data acquisition can be interrupted if necessary and resumed later on. Confirmed and submitted data go directly to statistical evaluation to the IFAS. The mean online time per reported ERCP was 5 min and 58 s. For reporting of late complications of readmitted patients, data can easily be linked back. Individual annual reports of each center are provided by the IFAS. Outcomes and definitions
The primary outcome measurement was defined as the assessment of complication and success rates. The secondary outcome measurement was assessed as rates of pancreatitis prophylaxis, technique of cannulation, difficult cannulation, peri-interventional administration of antibiotics, and complication rates with respect to center size.
Laboratory data Diagnosis
ERCP, endoscopic retrograde cholangiopancreatography.
Success rates were defined as visualization and cannulation rate of the desired duct as well as the achievement of the therapeutic/diagnostic target [16,18]. The achievement of the therapeutic target was subdivided into yes and no in 2006 and 2007. Since 2009, it has been subdivided into entirely, partially, and not achieved [16]. According to the consensus criteria of Cotton, post-ERCP pancreatitis was defined as abdominal pain that develops or worsens, with at least a three-fold elevation in pancreatic enzymes 24–48 h after the intervention [22]. Post-ERCP cholangitis was defined as increased temperature (> 381C), leukocytosis, and abdominal pain [21]. The total bleeding rate was evaluated. Clinically significant bleeding was defined as bleeding requiring blood transfusions (moderate bleeding) or additional interventions (severe bleeding) [2,22]. Perforation was defined as radiological documented retroperitoneal or free abdominal air after ERCP. Cardiopulmonary complications were defined as systolic hypotension less than 90 mmHg for longer than 5 min, decreased oxygen saturation less than 90% for longer than 5 min, unplanned intubation, or resuscitation. Within the first 2 years of the survey, administration of antibiotic prophylaxis was evaluated. In 2009, the unclear phrasing was changed to peri-interventional antibiotics including prophylaxis as well as therapeutic administration. Since 2010, the questionnaire asks for the following burning issues. Post-ERCP pancreatitis prophylaxis was
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Results of a nationwide ERCP benchmarking project Kapral et al. 1449
assessed as pancreatic stenting for prophylactic reasons only or application of 100 mg diclofenac or indomethacin rectally [20,23]. Difficult cannulation was defined as the failure of deep cannulation of the desired duct after 10–15 attempts or after 10 min [20]. The technique of cannulation was evaluated; the questionnaire asks whether cannulation was wire-guided or standard contrast-assisted. High-volume centers were defined as centers performing more than 200 procedures/year; low-volume centers were defined as centers performing less than 200 ERCP/year [3]. Statistical analysis
Associations between two categorical variables were assessed by bivariate analysis using the w2-test. Bivariate analysis of binary categorical variables was carried out using Fisher’s exact test instead of the asymptotic w2-test. All reported P values were for a two-tailed test, and a P value less than 0.05 was considered statistically significant. All statistical analyses were carried out using the software package statistical package for the social sciences 20.0 (IBM Corporation, New York, New York, USA). As some of the cases without all the required data were not completely excluded from the analysis, the number of valid cases differs slightly for different but corresponding analysis.
Results: Participating centers and patients
Forty-two sites participated in the benchmarking ERCP project for varying periods (1 month up to 5 years) and reported 13 513 procedures (5–565/center/year); 89.4% of them proved to be therapeutic. Fourteen centers were highvolume centers performing more than 200 ERCP/year and reported 67.8% of all ERCP; 28 were low-volume centers performing less than 200 ERCP/year. Of the patients, 54.0% were women and 46.0% were men. Analysis for sex-related complications showed no difference in bleeding, post-ERCP pancreatitis, and perforation. Cholangitis was significantly higher in men (1.7 vs. 1.1%, P = 0.011), and also cardiopulmonary complications (1.4 vs. 0.9%, P = 0.014). The patients ranged in age from 3 to 103 years, with a mean age of 68 years. Analysis for age-dependent complications showed that post-ERCP pancreatitis, bleeding, and cardiopulmonary complications correlated with age. Post-ERCP pancreatitis was significantly higher in patients younger than 65 years of age (5.6 vs. 3.4%, P < 0.001), whereas bleeding (2.4 vs. 4.2%, P < 0.001) and cardiopulmonary complications (0.8 vs. 1.4%, P = 0.006) were significantly higher in patients older than 65 years of age. To identify patients who are at an increased risk, we looked for serious disorders in the history. More than onethird (36.0%) of the patients had at least one severe
comorbidity, most commonly heart disease (19.3%). The bleeding rate (4.8 vs. 2.9%, P < 0.001) and cardiopulmonary complications (2.6 vs. 0.4%, P < 0.001) were significantly higher in patients with comorbidity. PostERCP pancreatitis was unexpectedly low in patients with concomitant diseases (3.6 vs. 4.5%, P = 0.021). Technical feasibility and interventions
The papilla could be reached in 97.8% of all ERCPs. The common bile duct was visualized in 88.7% and the pancreatic duct in 29.8% of procedures. Sphincterotomy was performed in 54.2% and previous sphincterotomy was extended in 2.3% of procedures; 35.4% of patients had a history of sphincterotomy. Plastic or metal stents were newly placed in 17.6% of patients (15.4% bile duct, 1.9% pancreatic duct, 0.3% both ducts). Stents were exchanged in 9.7% of patients (bile duct 8.5%, pancreatic duct 1.0%, both ducts 0.1%) and removed in 5.5% of patients (bile duct 5.2%, pancreatic duct 0.4%, both ducts 0.1%). Stones were removed from the common bile duct in 37.6% of all ERCPs, which reflects the main indication for ERCP. In choledocholithiasis, stones were completely removed in 89.3% and partially in 4.6% of procedures. In 0.8%, stones were extracted from the pancreatic duct and in 1.1% from intrahepatic ducts. Lithotripsy was performed in 3.6%. Nasobiliary tubes were placed in 2.2% and duct dilation was performed in 4.0%. Primary outcomes
The main benchmarks are complication and success rates. The overall therapeutic and diagnostic target was achieved in 84.8% (2006/2007) and 80.3% (2009–2011) of procedures, respectively (Table 2). The desired duct was visualized in 90.7%. The overall cannulation rate of the desired duct was 88.8% (Table 2). The overall complication rate in nonselected patients was 10.1% (Table 3). In our survey, 4.2% of all reported patients experienced postERCP pancreatitis, including one procedure-related death. ERCP-induced pancreatitis was significantly more frequent in patients younger than 65 years of age (5.6 vs. 3.4%, P < 0.001) as well as in patients with difficult biliary cannulation (8.4 vs. 2.7%, P < 0.001). The pancreatitis rate was slightly higher in female (4.3%) than in male patients (3.8%), but the difference was not statistically significant. Normal bilirubin level (r 1.0 mg/dl) was associated with a higher post-ERCP pancreatitis rate (6.4 vs. 3.7%, P < 0.001). Precut sphincterotomy with an Erlanger pull-type sphincterotome was associated with an increased post-ERCP pancreatitis rate (7.9 vs. 4.1%, P = 0.02), whereas needle knife sphincterotomy was not associated with an increased rate of post-ERCP pancreatitis. Total bleeding rate, immediate and delayed, was 3.6%. In 51 patients (0.4%), the bleeding was clinically relevant requiring blood transfusions and, in five cases, surgery. If
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1450 European Journal of Gastroenterology & Hepatology 2012, Vol 24 No 12
Table 2
Success rates % (n/valid cases) Total 2006–2007
2009–2011
Achievement of the therapeutic target Yes 84.8 (4056/4782) No 15.2 (726/4782) Partially a
80.3 (6850/8531) 10.3 (877/8531) 9.4 (804/8531)
Visualization of the desired duct Yes 90.7 (12048/13288) No 9.3 (1240/13288) Cannulation of the desired duct Yes 88.8 (11803/13292) No 11.2 (1489/13292)
2006
2007
2009
2010
2011
84.9 (2732/3219) 15.1 (487/3219) a
84.7 (1324/1563) 15.3 (239/1563) a
79.3 (1983/2500) 11.2 (281/2500) 9.4 (236/2500)
80.3 (2281/2839) 10.3 (292/2839) 9.4 (266/2839)
81.0 (2586/3192) 9.5 (302/3192) 9.5 (302/3192)
90.8 (2935/3232) 9.2 (297/3232)
89.7 (1415/1578) 10.3 (163/1578)
89.8 (2229/2582) 10.2 (253/2482)
90.9 (2536/2791) 9.1 (255/2791)
91.5 (2933/3205) 8.5 (272/3205)
89.0 (2870/3226) 11.0 (356/3226)
87.5 (1382/1579) 12.5 (197/1579)
87.7 (2154/2457) 12.3 (303/2457)
89.3 (2514/2816) 10.7 (302/2816)
89.7 (2883/3214) 10.3 (331/3214)
a
Not evaluated.
Table 3
Complication rates % (n/valid cases) 2006
Number of ERCP Total complication rate Pancreatitis Bleeding (clinically relevant) Cholangitis Perforation Cardiopulmonary Death
3251 11.1 (344/3098) 5.1 (160/3158) 3.6 (117/3228) (0.5) 1.8 (60/3251) 0.6 (18/3221) 1.0 (31/3197) 0.09 (3/3251)
2007 1587 10.1 (155/1539) 4.3 (67/1559) 3.7 (59/1576) (0.8) 1.0 (16/1587) 0.8 (13/1576) 1.0 (16/1571) 0.06 (1/1587)
2009 2546 8.4 (215/2546) 4.0 (102/2546) 2.2 (57/2546) (0.2) 1.3 (33/2546) 0.6 (16/2546) 1.2 (30/2546) 0.04 (1/2546)
2010 2886 10.7 (308/2886) 4.4 (126/2886) 4.2 (122/2886) (0.3) 1.0 (28/2886) 0.6 (17/2886) 1.5 (44/2886) 0.07 (2/2886)
2011 3243 9.7 (316/3243) 3.2 (105/3241) 3.9 (127/3241) (0.3) 1.5 (48/3241) 0.6 (21/3241) 1.2 (39/3241) 0.00 (0/3243)
Total 13 513 10.1 (1338/13312) 4.2 (560/13390) 3.6 (482/13477) (0.4) 1.4 (185/13511) 0.6 (85/13470) 1.2 (160/13441) 0.05 (7/13513)
ASGE (%)[12] a a
1.6–15.7 1.3 – (0.4) 1 0.1–0.6 1 – 0.2 –
ASGE, American Society for Gastrointestinal Endoscopy; ERCP, endoscopic retrograde cholangiopancreatography.
patients had any severe comorbidity, the bleeding rate was significantly higher (4.8 vs. 2.9%, P < 0.001). Multimorbidity might explain why 26.9% of all patients were under anticoagulation (ASS 7.1%, clopidogrel 0.5%, coumarin 1.9%, NMH 13.2%; combinations of two or three anticoagulants 3.1%) during the procedure. The bleeding rate was significantly higher in patients with rather than without anticoagulant therapy (5.7 vs. 2.8%, P < 0.001), and was independent of the anticoagulant agent. There was no significant difference in the bleeding rate whether the patients received one or more anticoagulants. Bleeding occurred mainly after sphincterotomy (5.6 vs. 1.2%, P < 0.001) and in patients older than 65 years of age (2.4 vs. 4.2%, P < 0.001).
In our survey, post-ERCP cholangitis was observed in 1.4% of all patients. It was significantly higher in men (1.7 vs. 1.1%, P = 0.011). Cardiopulmonary complications during ERCP occurred in 160 patients, which equals 1.2%; in detail: systolic hypotension less than 90 mmHg for longer than 5 min (47 patients), decreased oxygen saturation less than 90% for longer than 5 min (98 patients), unplanned intubation (24 patients), and resuscitation (eight patients). Four patients died of cardiopulmonary complications during the procedure. If patients had any severe comorbidity, cardiopulmonary complications were significantly higher (2.6 vs. 0.4%, P < 0.001). The same applied to patients
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Results of a nationwide ERCP benchmarking project Kapral et al. 1451
older than 65 years of age (0.8 vs. 1.4%, P = 0.006), to male patients (1.4 vs. 0.9%, P = 0.014), and in difficult biliary cannulation (2.6 vs. 1.1%, P < 0.001). Retroperitoneal or free perforation was observed in 85 (0.6%) patients and required surgery in 20 (0.1%) patients. Fiftyseven (67.1%) perforations occurred with sphincterotomy. Perforation was significantly more frequent in patients with difficult biliary cannulation (2.0 vs. 0.3%, P < 0.001). Eighty-eight patients (0.7%) experienced more than one complication. Seven procedure-related deaths were reported (0.05%), four because of cardiopulmonary complications, two because of perforation, and one because of pancreatitis. Secondary outcomes
Since 2010, the questionnaire asks for technique of cannulation (wire-assisted or standard contrast-assisted), difficult biliary cannulation, and pancreatitis prophylaxis. A guide wire for cannulation was used in 84.6%; 33.8% of these patients had undergone previous sphincterotomy. In the standard contrast-assisted cannulation, 49.3% of patients had undergone previous sphincterotomy. The overall post-ERCP pancreatitis rate was significantly higher when a guide wire was used (4.3 vs. 1.3%, P < 0.001). In patients with intact papilla, pancreatitis rate was even higher in wire-assisted cannulation (5.5 vs. 1.5%, P < 0.001). Overall, 19.0% of patients had difficult biliary cannulation, and were at an increased risk for post-ERCP pancreatitis (8.4 vs. 2.7%, P < 0.001), perforation (2.0 vs. 0.3%, P < 0.001), and cardiopulmonary complications (2.6 vs. 1.1%, P < 0.001).
Indications and final diagnoses
In 40.2% of all procedures, the diagnosis was ‘bile duct stones’, which indicates the main indication for ERCP. In several cases (28.0%), there was more than one indication/diagnosis for ERCP. During the first 2 years, the questionnaire asked for indication and final diagnosis using an identical list of possible answers. Statistical analysis showed that indication and final diagnosis agreed very well. Since 2009, the questionnaire asks whether the final diagnosis matches either accurately, or partially, or not with the indication. This question was answered as follows: 80.0% accurate, 13.2% partial, and 6.8% no agreement of indication with the final diagnosis. Details on the diagnoses are listed in Table 4.
Discussion According to the European and the American Society of Gastrointestinal Endoscopy, continuous quality improvement should be an integral part of an ERCP program [15,17,18]. These societies have established internationally recognized quality indicators for ERCP that allow the implementation of quality assurance programs [14–20]. Naylor et al. [17] recommended that data from several centers should be pooled to establish ‘benchmark’ data against which data from individual centers should be compared. The OeGGH has achieved such an integral program for continuous quality improvement by the Austrian ERCP benchmarking project [13]. The participating centers are able to compare their own results on the effectiveness of ERCP with the pooled benchmark data of other centers. Individual problems with respect to success and complication rates can be identified and consequently be corrected.
During the first 2 years of the survey, antibiotic prophylaxis was administered in 13.4% of patients. In 2009, the phrasing was changed, which might have been unclear. Peri-interventional administration of antibiotics including prophylaxis as well as therapeutic administration was 49.6% in 2009, 57.2% in 2010, and 59.4% in 2011 of all procedures.
The Austrian benchmarking project on ERCP provides an overview of success and complication rates in prospectively collected multicenter data from both academic and community-based endoscopy services with varying case volumes and expertise. Key research questions on the overall technical success rate and safety of ERCP might partly be answered by this project [18,19]. Austria has a population of 8 million, with up to an estimated 15 000 ERCP/year. In 2006, 140 sites and in 2010, 118 sites were registered to perform ERCP. The declining number of centers might reflect the increasing specialization in medicine. Forty-two sites participated in the benchmarking ERCP project for varying periods (1 month up to 5 years) and reported 13 513 procedures within 5 years; 89.4% of them proved to be therapeutic.
Fourteen of 42 centers were high-volume centers performing more than 200 ERCP/year. High-volume centers reported 67.8% of all ERCP and had increased rates of bleeding (4.3 vs. 3.2%, P = 0.003) and cardiopulmonary complications (1.7 vs. 1.0%, P < 0.001). In terms of center size, there was no difference in postERCP pancreatitis, cholangitis, and perforation.
The overall complication and success rates are consistent with the available literature data (Table 2) [2–12]. The overall cannulation rate of the desired duct was 88.8%. It has been proposed that the minimum acceptable cannulation rate for endoscopists is between 80 and 90% [18]. In our survey, post-ERCP pancreatitis occurred in 4.2%, which confirms the literature data of post-ERCP
Pancreatitis prophylaxis was carried out in 5.5% (diclofenac/indomethacin 3.3%, pancreatic stenting 2.0%, both 0.2%). In 2010, it was 4.0% (diclofenac/indomethacin 2.8%, pancreatic stenting 1.1%, both 0.1%); in 2011, it was 7.0% (diclofenac/indomethacin 3.8%, pancreatic stenting 2.9%, both 0.3%). Prophylaxis was associated with an increased post-ERCP pancreatitis rate (9.9 vs. 2.7%, P < 0.001).
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1452 European Journal of Gastroenterology & Hepatology 2012, Vol 24 No 12
Table 4
Endoscopic retrograde cholangiopancreatography diagnoses in nonselected patients Total 2006/2007
Number of ERCP Cholangitis (%) Bile duct stones (%) Intrahepatic duct stones (%) Pancreatic duct stones (%) Strictures of bile duct (%) Benigne Maligne Unclear Any Strictures of the pancreatic duct (%) Benigne Maligne Unclear Any Papillary tumor (%) Benigne Maligne Unclear Any Biliary pancreatitis (%) Chronic pancreatitis (%) Sphincter of oddi dysfunction (%) SOD I SOD II SOD III Any SOD Liver transplantation (%) Others (%)b
2009–2011 13 513 15.0 40.2 1.4 1.3
10.3 16.1 6.1
a
a
28.2
a a
a
2.6 2.5 2.0
a a
a
4.3 a
0.7 1.2 1.3
a a
a
2.1
5.7 5.7 a
1.6 1.1 0.7
a a
a
2.8 1.6 35.9
2006
2007
2009
2010
2011
3251 12.5 36.4 1.4 1.4
1587 13.0 39.8 0.8 1.0
2546 15.6 41.6 1.6 0.9
2886 16.6 41.5 1.6 1.0
3243 16.8 41.9 1.3 1.9
11.3 16.1 6.6
8.3 16.0 5.0
a
a
a
a
a
a
a
a
a
a
a
27.1
28.6
28.7
a
a
a
a
a
a
a
a
2.9 3.0 2.5 a
0.4 1.3 1.1 a
1.8 1.5 1.0 a
1.3 0.9 1.6 a
5.3 6.8
5.2 5.7
1.5 0.9 0.6
1.7 1.4 0.9
a
a
5.2 38.8
0.7 38.5
3.8
4.0
a
4.9
a
a
a
a
a
a
a
a
1.7 5.8 4.7
2.2 6.2 4.4
a
2.4 5.8 6.7
a
a
a
a
a
a
a
a
a
2.8 0.1 36.9
3.1 0.1 34.9
2.5 1.1 31.9
a
Not evaluated. Others include biliary leakage, PSC, pancreatic pseudocysts, exclusion of duct pathologies, IPMN, etc.
b
pancreatitis in 1.6–15.7% in prospective series [12]. ERCP-induced pancreatitis was significantly more frequent in patients younger than 65 years of age than in patients older than 65 years of age (5.6 vs. 3.4%, P < 0.001), which has been reported previously [2–4,12]. The pancreatitis rate was slightly higher in female (4.3%) than in male patients (3.8%), but the difference was not statistically significant. Increased pancreatitis rates in women had been observed by Cheng et al. [24]. Normal bilirubin level (r 1.0 mg/dl) was associated with a higher post-ERCP pancreatitis rate (6.4 vs. 3.7%, P < 0.001), which confirms the literature data [2,9]. Fifty-one patients (0.4%) experienced clinically relevant bleeding requiring blood transfusions and, in five cases, surgery [2,22]. These data agree with the reported incidence rate in the literature [2,11,12]. Post-ERCP cholangitis was observed in 1.4% of all patients. In the literature, the post-ERCP cholangitis rate ranges from 1 to 2% [6,8,11,12]. Cardiopulmonary complications during ERCPs have been reported in the literature to occur in about 1% of patients [4,5,8,11,12]. In our survey, 1.2% of patients experienced this kind of complication. Retroperitoneal or free perforation was observed in 0.6% of patients and required surgery in 0.1%. The overall incidence of perforation during ERCP has been reported to be 0.3–0.6% depending on the definition of perforation [3,4,11,12]. In our survey, seven procedure-related deaths were reported (0.05%), four because of cardio-
pulmonary complications, two because of perforation, and one because of pancreatitis. Procedure-related death has been reported in the literature to be 0.07–0.4% [11,12]. High-volume centers performing more than 200 ERCP/ year had an increased risk for bleeding (4.3 vs. 3.2%, P = 0.003) and cardiopulmonary complications (1.7 vs. 1.0%, P < 0.001). It has been reported previously that complication rates are more frequent in high-volume university-affiliated centers [2,3]. This fact has been attributed to different case mixes and the involvement of trainees. An established preprocedure quality indicator is an appropriate indication and patient workup [18,19]. To cope to some extent with this quality indicator, the questionnaire asks whether the final diagnosis matches either accurately, or partially, or not with the indication. This question was answered as accurate in 80.0%, as partial in 13.2%, and as no agreement with the final diagnosis in 6.8%. A meta-analysis of the general administration of antibiotics for ERCP showed no beneficial effect [25]. Still, several guidelines recommend it for high-risk patients and incomplete biliary drainage [12,26–29]. Prophylactic administration of antibiotics was 13.4% during the first 2 years of our survey. After the first 2 years, the phrasing that might have been unclear has been changed to
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Results of a nationwide ERCP benchmarking project Kapral et al. 1453
peri-interventional administration of antibiotics. This includes prophylaxis as well as antibiotic therapy. The use of antibiotics increased from 49.6% in 2009 to 57.2% in 2010 and even further to 59.4% in 2011.
projects for high-risk endoscopic procedures should be achieved under the influence and patronage of the ESGE.
Since 2010, the questionnaire asks for the technique of cannulation, difficult biliary cannulation, and pancreatitis prophylaxis. A guide wire for cannulation was used in 84.6%. Interestingly, post-ERCP pancreatitis was significantly higher in patients who underwent wire-assisted cannulation (4.3 vs. 1.3%, P < 0.001). This observation does not agree with the literature data [30,31]. Even in patients without previous sphincterotomy, the pancreatitis rate was significantly higher when a guide wire was used (5.5 vs. 1.5%, P < 0.001). Patients with difficult biliary cannulation are known to be at an increased risk for post-ERCP pancreatitis [6,20]. In our survey, difficult cannulation was reported in 19.0%, with increased rates of post-ERCP pancreatitis (8.4 vs. 2.7%, P < 0.001), perforation (2.0 vs. 0.3%, P < 0.001), and cardiopulmonary complications (2.6 vs. 1.1%, P < 0.001). Pancreatitis prophylaxis was carried out in 5.5%. It increased from 4.0% in 2010 to 7.0% in 2011, which can be attributed to the ESGE guidelines on the prophylaxis of post-ERCP pancreatitis published in 2010 [20]. At the same time, the total post-ERCP pancreatitis rate decreased from 4.4% in 2010 to 3.2% in 2011. However, post-ERCP pancreatitis was significantly higher in patients who received a prophylaxis (2.7 vs. 9.9%, P < 0.001). This finding is inconsistent with recent publications [20,23]. The discrepancy is presumably because of a lack of randomization. We speculate that mainly patients who were a priori at an increased risk received a pancreatitis prophylaxis; further data workup should be carried out.
Acknowledgements
Our data present an uncontrolled prospective survey with several limitations. It should be noted that the survey is based on voluntary participation, with uncertain data completeness. A final audit after the first year showed that 83.3% of all procedures performed at the participating centers had been reported [13]. Moreover, several cases showed missing information. They were not completely excluded except for the corresponding analysis. Therefore, the number of valid cases can differ slightly for different analyses. Conclusion
The aim of the running benchmarking project in ERCP is to improve patient care in Austria. The survey reflects the general effectiveness and safety of ERCP from both academic and community-based endoscopy services with varying case volumes and expertise. The overall complication and success rates are in general consistent with the available literature data. Encouraged by the Austrian benchmarking project, other countries might also establish continuous quality assessment programs. Ideally, international or even pan-European benchmarking
The participating centers in alphabetical order were as follows: ¨ KH des Deutschen Ordens Friesach, 2009–2011. AO ¨ KH Gu AO ¨ssing, 2006–2007, 2009–2010. ¨ KH Oberpullendorf, 2006–2007. AO Facharzt Dr. Minar, 2006. KAV AKH der Stadt Wien (Medizinische Universita¨t Wien), 2006–2007. KAV Hietzing, 2006. KAV Rudolfstiftung, 2009. KAV Sozialmedizinisches Zentrum Su ¨d, Kaiser-FranzJosef-Spital, 2009–2011. KAV Wilhelminenspital, 2006–2007. KH Barmherzige Bru ¨der Graz, 2009. KH Barmherzige Bru ¨der Linz, 2006–2007, 2009–2011. KH Barmherzige Bru ¨der St. Veit/Glan, 2006–2007, 2009–2011. KH Barmherzige Schwestern Linz, 2009–2011. KH Barmherzige Schwestern Wien, 2006. KH Barmherzige Schwestern Ried, 2006–2007, 2009–2011. KH Elisabethinen Graz, 2006–2007. KH Elisabethinen Linz, 2009–2011. KH Go¨ttlicher Heiland Wien, 2007, 2009. KH Schwarzach (Kardinal Schwarzenberg‘sches Krankenhaus), 2006. KH St. Josef Braunau, 2006, 2009–2011. Klinikum Wels, 2006–2007, 2009–2011. Landesklinikum 2010–2011.
Mistelbach-Ga¨nserndorf,
2006–2007,
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
1454 European Journal of Gastroenterology & Hepatology 2012, Vol 24 No 12
Landesklinikum St. Po¨lten, 2006–2007, 2009–2011.
6
Landesklinikum Tulln, 2006.
7
Landesklinikum Waidhofen, 2009. Landesklinikum Wiener Neustadt, 2006–2007, 2009–2011. Landesklinikum Zwettl, 2006–2007, 2009–2011. LKH Deutschlandsberg, 2009–2011.
8 9 10
11
LKH Feldbach, 2006–2007, 2009. 12
LKH Feldkirch, 2006.
13
LKH Graz West, 2009–2011. 14
LKH Judenburg, 2006. 15
LKH Klagenfurt, 2010–2011.
16
LKH Lilienfeld, 2006.
17
LKH Oberwart, 2009–2011.
18
LKH Scha¨rding, 2006.
19
LKH Villach, 2006–2007.
20
LKH Wagna, 2009–2011.
21
LKH Wolfsberg, 2006, 2009–2011.
22
LKH Leoben/Eisenerz, 2009–2011.
23
Medizinische Universita¨t Graz (Prof. Schreiber only participant), 2006, 2009.
24
Medizinische Universita¨t Innsbruck, 2006–2007, 2010–2011.
25
26
Conflicts of interest
There are no conflicts of interest. 27
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