Pharmacologic treatment can prevent pancreatic injury after ERCP: a meta-analysis

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Pharmacologic treatment can prevent pancreatic injury after ERCP: a meta-analysis Angelo Andriulli, MD, Gioacchino Leandro, MD, Grazia Niro, MD, Alessandra Mangia, MD, Virginia Festa, MD, Giovanni Gambassi, MD, Maria Rosaria Villani, MD, Domenico Facciorusso, MD, Pasquale Conoscitore, MD, Fulvio Spirito, MD, Giovanni De Maio, MD Rome, Italy

Background: The identification of therapeutic agents that can prevent the pancreatic injury after endoscopic retrograde cholangiopancreatography (ERCP) is of considerable importance. Methods: We performed a meta-analysis including 28 clinical trials on the use of somatostatin (12 studies), octreotide (10 studies), and gabexate mesilate (6 studies) after ERCP. Outcome measures evaluated were the incidence of acute pancreatitis, hyperamylasemia, and pancreatic pain. Three analyses were run separately: for all available studies, for randomized trials only, and for only those studies published as complete reports. Results: When all available studies were analyzed, somatostatin and gabexate mesilate were significantly associated with improvements in all three outcomes. Odds ratios (OR) for gabexate mesilate were 0.27 (95% CI [0.13, 0.57], p = 0.001) for acute pancreatitis, 0.66 (95% CI [0.48, –0.89], p = 0.007) for hyperamylasemia, and 0.33 (95% CI [0.18, 0.58], p = 0.0005) for post-procedural pain. Somatostatin reduced acute pancreatitis (OR 0.38: 95% CI [0.22, 0.65], p < 0.001), pain (OR 0.24: 95% CI [0.14, 0.42], p < 0.001), and hyperamylasemia (OR 0.65: 95% CI [0.48, 0.90], p = 0.008). Octreotide was associated only with a reduced risk of post-ERCP hyperamylasemia (OR 0.51: 95% CI [0.31, 0.83], p = 0.007) but had no effect on acute pancreatitis and pain. The statistical significance of data did not change after analyzing randomized trials only or studies published as complete reports. For each considered outcome, the publication bias assessment and the number of patients that need to be treated to prevent one adverse effect were, respectively, higher and lower for somatostatin than for gabexate mesilate. Conclusions: The pancreatic injury after ERCP can be prevented with the administration of either somatostatin or gabexate mesilate, but the former agent is more cost-effective. Additional studies comparing the efficacy of short-term infusion of somatostatin versus gabexate mesilate in patients at high risk for post-ERCP complications seem warranted. (Gastrointest Endosc 2000;51:1-7.)

ERCP is a valuable procedure for the diagnosis and treatment of several biliary and pancreatic conditions. Nonetheless, ERCP can cause acute pancreatitis (AP) and result in significant morbidity and mortality.1,2 Depending on the definition, postERCP AP has been reported in 1% to 40% of cases, whereas hyperamylasemia is present in up to 70% of cases.3 Initial attempts at therapy were directed at suppressing pancreatic secretion, and the prophylactic use of somatostatin (SS) and its long-acting analog

Received February 4, 1998. For revision September 10, 1998. Accepted June 24, 1999. From the Divisions of Gastroenterology, Ospedale “Casa Sollievo della Sofferenza,” IRCCS, San Giovanni Rotondo, and Ospedale “De Bellis,” IRCCS, Castellana Grotte, Internal Medicine, Catholic University, Rome, Italy. Reprint requests: Angelo Andriulli, MD, Division of Gastroenterology, “CSS Hospital,” 71013 San Giovanni Rotondo, Rome, Italy; fax: 39-882-411-879. Copyright © 2000 by the American Society for Gastrointestinal Endoscopy 0016-5107/2000/$12.00 + 0 37/1/101044 VOLUME 51, NO. 1, 2000

octreotide (OCT) have been evaluated in several trials. These have generated contradictory results, but many did not have sufficient power to demonstrate clinical usefulness. The activation of proteases has been recognized as the key event in the pathogenesis of AP, and agents that inhibit proteolytic activity have been tested in several studies. However, results have been similarly contradictory. Recently, Cavallini et al.4 reported that prophylactic treatment with gabexate mesilate (FOY) reduced pancreatic injury after ERCP, but in other studies the drug has shown only a marginal effect.5-9 Conclusive evidence on the effectiveness of antisecretory or antiprotease agents and their comparison will come only from large prospective randomized studies. Meanwhile, a meta-analysis of all available studies may provide useful therapeutic information. To this end, we performed a meta-analysis of all English language and non-English language (Italian, Spanish, Japanese, and German) reports of clinical trials in which SS, OCT, or FOY were used prophylactically to prevent pancreatic injury after ERCP. GASTROINTESTINAL ENDOSCOPY

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A Andriulli, G Leandro, G Niro, et al.

Prevention of pancreatic injury after ERCP: meta-analysis

Figure 2. Effect of gabexate mesilate on the frequency of ERCP-related acute pancreatitis (see Figure 1). icant result at meta-analysis into a non-significant one.34 This approach was taken only for those analyses pointing toward significant differences in the efficacy of treatments. Figure 1. Effect of somatostatin on the frequency of ERCPrelated acute pancreatitis. Underneath the box with the standard plot is the corresponding plot for aggregated data. Numbers on the x axis refer to the individual trials, as cited in the reference list. METHODS

The number needed to be treated (NnT) Given the observed risk difference, the number of patients that need to be treated to prevent one adverse effect was also used as a measure of treatment effect. For computation, NnT = 1/risk difference.

RESULTS

Review of the published reports We searched primarily the Medline database (1978 to 1998) under the following headings: somatostatin, octreotide, gabexate mesilate, ERCP, amylase, and acute pancreatitis. The reference lists of pertinent reviews and retrieved articles were also checked to identify additional studies. In the meta-analysis we included exclusively controlled trials comparing active treatment with placebo that were published as complete reports or in abstract form. A total of 28 trials were identified: 6 trials evaluated the effect of FOY,4-9 12 of SS,10-21 and 10 of OCT.22-31 All but two9,17 trials were available as complete reports. Nineteen studies were randomized trials, 8 on SS,13-15,17-21 9 on OCT,22-27,2931 and 2 on FOY.4,9 All the studies were independently evaluated by two of us considering three primary outcomes: occurrence of AP, frequency of serum amylase elevation, and presence of pancreatic pain. Discrepancies in the evaluation of some of the studies were resolved by with discussion between reviewers. The main features of the trials included in the meta-analysis are shown in Tables 1 through 3. Statistical analysis The meta-analysis was carried out by a biostatistician (G.L.), using a fixed-effect model (Peto’s method),32 as previously described.33 Whenever the heterogeneity χ2 test was significant, a random effects model was used.32 Three analyses were run separately: for all available studies, for randomized trials only, and for works published as complete reports only. Results are presented as standard plots and in further detail as Galbraith radial plots in the Appendix. We have taken the meta-analytical result as evidence of treatment efficacy if pooled ORs were significantly reduced, if one or more studies showed significant benefit, and if there was no clinical or statistical heterogeneity across the trials. Publication bias assessment This was based on estimating the minimum number of negative (or null) studies it would take to reverse a signif2

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Acute pancreatitis Data were derived from 10 trials of SS, 8 of OCT, and 4 of FOY. These studies included 321 patients treated with SS versus 325 control patients, 423 patients treated with OCT versus 430 control patients, and 311 patients treated with FOY versus 369 control patients. AP developed in 13.5% of control patients versus 5.6% of treated cases with SS, in 5.6% versus 7.6% with OCT, and in 6.5% versus 1.6% with FOY. The results of the meta-analysis for each agent are shown in Table 4: SS and FOY significantly reduced (p < 0.001 and p = 0.001, respectively) the incidence of AP after the endoscopic procedure (Figs. 1 and 2). A benefit was evident in each of the studies examined. In contrast, OCT had a not significant effect (p = 0.206). For each of the three drugs the results of the χ2 test of homogeneity of effect sizes were not significant. Most of the trials had a low (50%) relative error. The publication bias assessment was 5 for FOY and 15 for SS, while the number needed to treat with FOY was higher than that for SS (Table 4). Results changed neither after exclusion of the single study published only in abstract form,17 nor after considering only randomized trials (Table 4). Hyperamylasemia Data were derived from 10 studies of SS, 7 of OCT, and 6 of FOY. Information on this outcome was available for 321 patients treated with SS versus 322 control patients, 873 patients treated with OCT versus 860 control patients, and 356 patients treated with FOY versus 417 control patients. Postprocedural increase of serum amylase levels was VOLUME 51, NO. 1, 2000

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Table 1. Clinical trials on the use of gabexate mesilate for the prevention of pancreatic injury after ERCP Publication Author

Hajiro Kuno Shimizu Salamon Benini Cavallini

Controls

Gabexate mesilate

Design of Type of No. of Pain ↑Amylase Dosage Year Type the study treatment patients AP (%) (%) (%) (mg)

1978 1978 1979 1981 1985 1996

F F F F A F

C C C C R R

No No No No P P

123 20 17 19 28 210

2.4 UN 17.6 10.5 UN 7.6

UN 35 11.8 UN UN 13.8

40.7 55 70.6 73.7 14.3 67.6

200 100-200 100 150 300 1000

Duration No. of Pain ↑Amylase (hr) patients AP (%) (%) (%)

2 NR 2 2 5 12

69 17 16 18 28 208

0.0 UN 0.0 0.0 UN 2.4

UN 0.0 0.0 UN UN 5.8

27.5 23.5 37.5 61.1 3.6 64.4

F, Full paper (complete report); A, abstract; R, randomized; C, controlled; P, placebo; No, not reported; AP, acute pancreatitis; UN, unextractable data from published work.

Table 2. Clinical trials on the use of somatostatin for the prevention of pancreatic injury after ERCP Publication Author

Borsch Cicero Tyden Bordas Testoni Saari Flati Deschner Guerlund Persson Bordas Poon

Controls

Somatostatin

Design of Type of No. of Pain ↑Amylase Dosage Year Type the study treatment patients AP (%) (%) (%) (µg/hr)

1984 1985 1986 1988 1988 1988 1988 1989 1991 1992 1998 1999

F F F F F F F A F F F F

C R C R R R C R R R R R

P P No P P P P P P P P P

10 19 21 17 26 22 15 8 8 28 80 111

10.0 UN UN 11.8 19.3 18.2 6.7 12.5 75.0 17.9 10.0 9.9

UN 100.0 — 64.7 — 15.4 26.6 — 75.0 — — 16.2

20.0 — 57.1 94.1 — 53.8 33.3 50.0 100.0 60.9 53.7 53.2

250 250 250 4* 250 250 250 50 250 300 4* 250

Duration No. of Pain ↑Amylase (hr) patients AP (%) (%) (%)

24 4 24 Bolus 26 3 12 Bolus 13 4 Bolus 12

10 19 26 16 27 17 11 17 8 26 80 109

10.0 — — 0.0 7.4 11.8 0.0 11.8 25.0 15.4 2.5 2.8

— 52.6 — 12.5 — 9.5 0.0 — 25.0 — — 7.3

40.0 — 57.7 50.0 — 42.9 18.1 29.4 100.0 39.1 50.0 40.4

F, Full paper (complete report); A, abstract; R, randomized; C, controlled; AP, acute pancreatitis; P, placebo; No, not reported; UN, unextractable data from published work *4 µg/kg as a single bolus injection.

Table 3. Clinical trials on the use of octreotide for the prevention of pancreatic injury after ERCP Publication

Controls

Octreotide

↑Amylase Dosage AP (%) Pain (%) (%) (mg)

Author

Design of No. of Year Type the study patients

Tulassay Sternlieb

1991 1992

F F

R R

34 44

UN 11.4

UN —

44.1 —

0.1 0.1 × 2

Binmoeller

1992

F

R

124

1.6

18.5



0.1 × 2

Russo

1992

F

R

50

4.0



26.0

0.1 × 3

Testoni Arcidiacono

1994 1994

F F

R R

20 76

0.0 6.6

— —

70.0 34.2

0.01 0.1 × 3

Baldazzi

1994

F

C

50

6.0



36.0

0.1 × 2

Testoni Tulassay

1996 1998

F F

R R

30 600

10.0 —

43.3 8.0

66.7 36.0

0.2 × 3 0.1 × 2

Arvantidis

1998

F

R

36

11.1





0.1 × 3

Schedule

No. of patients AP (%)

45 min before Before and 45 min after Before and 45 min after Before, 8 and 16 hr after 30 min before Before and 4 hr after 45 min before and 6 hr after 8, 16, and 0 hr before Before and 45 min after 30 min before and 6 and 16 hr after

Pain (%)

↑Amylase (%) 10.3 —

29 40

— 35

— —

121

2.5

17.4

50

8.0



24.0

20 75

5.0 6.7

— —

50.0 29.3

50

2.0



24.0

50 599

0.0 —

6.7 7.7

20.0 32.1

37

10.8







F, Full paper (complete report); R, randomized; C, controlled; AP, acute pancreatitis; UN, unextractable data from published work. VOLUME 51, NO. 1, 2000

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Figure 3. Effect of octreotide on the frequency of ERCPrelated increase of serum amylase levels (see Figure 1).

Prevention of pancreatic injury after ERCP: meta-analysis

Figure 5. Effect of somatostatin on the frequency of ERCPrelated pancreatic pain (see Figure 1).

Figure 6. Effect of gabexate mesilate on the frequency of ERCP-related pancreatic pain (see Figure 1). Figure 4. Effect of gabexate mesilate on the frequency of ERCP-related increase of serum amylase levels (see Figure 1).

noted in 55.0% of control patients versus 44.9% of cases treated with SS, in 37.4 % versus 30.2% treated with OCT, and in 55.9% versus 49.2% treated with FOY. The results of the meta-analysis for each agent are shown in Table 4. All the three agents appeared to significantly affect this outcome (p = 0.008 for SS, p = 0.001 for OCT, and p = 0.007 for FOY) (Figs. 3 and 4). A benefit was evident in each of the studies examined. The results of the chisquare test of homogeneity of effect sizes were not significant for SS and FOY. Because the results were significant for FOY (p = 0.005), a random effects model of testing for treatment effect was used. A relative error of less than 50%, that is to say a precision level greater than 2, was noted in all but two studies of SS, in 2 of 6 trials of FOY, and in 4 of 7 of OCT. The publication bias assessment was 6 for SS, 12 for OCT, and 5 for FOY. The Nnt was 9 for SS, 12 for OCT, and 11 for FOY (Table 4). Results did not change after exclusion of data published only in abstract form.9 When considering only randomized trials, results did not change for SS and OCT, whereas FOY turned out to have no significant effect on this outcome (Table 4). Pain Data were extracted from 6 trials of SS, 3 of OCT, and 3 of FOY. This outcome was evaluated on 184 4

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patients treated with SS versus 196 control patients, 750 patients treated with OCT versus 754 control patients, and 241 patients treated with FOY versus 247 control patients. Frequency of pain was 31.6% in control patients versus 13.0% of patients treated with SS, 11.1% versus 9.2% with OCT, and 15.4% versus 5.0% with FOY. The results of the metaanalysis for each agent are given in Table 4. Although the effect of OCT did not reach statistical significance, SS and FOY were associated with a positive effect on pain in all of the trials considered (p < 0.001 and p < 0.001, respectively) (Figs. 5 and 6). For SS and FOY the results of the chi-square test of homogeneity of effect sizes were not significant; results were significant for OCT (p = 0.01) and a random effects model of testing for treatment effect was used. Only for 4 trials4,21,23,29 was the precision of the studies acceptable (>50%). The publication bias assessment was 5 for FOY and 20 for SS. The Nnt was 10 for FOY and 6 for SS (Table 4). All studies of SS or FOY have appeared as complete reports. Only 1 study of FOY was a randomized trial, and this precluded a meta-analysis. Results did not change for SS after exclusion of the single non-randomized study.16 DISCUSSION Acute pancreatitis is the most frequent and serious complication of ERCP and endoscopic sphincterotomy. This complication cannot always be avoided and the search for drugs to prevent pancreatitis VOLUME 51, NO. 1, 2000

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Table 4. Meta-analysis of clinical trials on the use of somatostatin, octreotide, and gabexate mesilate for the prevention of pancreatic injury after ERCP Somatostatin End points

No. of studies

OR (95% CI)

Acute pancreatitis A 10 0.38 B 8 0.37 C 9 0.36 Pain A 6 0.24 B 5 0.25 C 6 0.24 ↑ Amylase A 10 0.65 B 7 0.61 C 9 0.66

Octreotide

Publication bias NnT

No. of studies

Gabexate mesilate

OR Publication (95% CI) bias NnT

No. of studies

OR (95% CI)

Publication bias NnT

(0.22-0.65) (0.21-0.64) (0.21-0.63)

15 13 14

13 13 13

8 7 8

1.43 (0.82-2.49) 1.61 (0.91-2.87) 1.43 (0.82-2.49)

— — —

— — —

4 1 4

0.27 (0.13-0.57) — 0.27 (0.13-0.57)

5 — 5

27 — 27

(0.14-0.42) (0.14-0.45) (0.14-0.42)

20 14 20

6 6 6

3 3 3

0.63 (0.28-1.43) 0.63 (0.28-1.43) 0.63 (0.28-1.43)

— — —

— — —

3 1 3

0.33 (0.18-0.58) — 0.33 (0.18-0.58)

5 — 5

10 — 10

(0.48-0.90) (0.43-0.86) (0.48-0.92)

6 6 4

9 7 9

7 6 7

0.51 (0.31-0.83) 0.49 (0.27-0.87) 0.51 (0.31-0.83)

12 8 12

12 13 12

6 2 5

0.66 (0.48-0.89) 0.82 (0.55-1.22) 0.67 (0.49-0.92)

5 — 3

11 — 11

A, All available studies; B, only randomized controlled trials; C, only full papers (complete report).

remains of considerable importance. After a careful review of published data we identified 28 clinical trials that evaluated the effect of administration of SS, OCT or FOY in the prevention of AP. The limited number of studies together with their low precision warrants further research in this important area. Our meta-analysis suggests that the administration of drugs can prevent the occurrence of pancreatic injury occurring after ERCP. Among the agents evaluated, SS and FOY were effective with regard to all of the end-points considered, frequency of AP, hyperamylasemia, and pain. Somewhat surprisingly, SS and its derivative OCT had divergent effects: OCT appeared to lower the frequency of post-procedural hyperamylasemia without affecting the incidence of AP or pain. Failure of OCT to protect against post-procedural AP was unexpected; one likely explanation might be the drug increases basal pressure of Oddi’s sphincter.35 From a pharmacoeconomic point of view, SS appears to be more cost-effective than FOY: the number of patients that need to be treated to prevent one single episode of AP (NnT) was 27 for FOY and only 13 for SS. Also for the other two outcomes considered, the NnT values were lower for SS than for FOY. These figures argue for a more marked effect of SS than FOY. The positive results of our analysis are robust only for SS, as the publication bias assessments for the outcomes AP and pain were 15 and 20, respectively. For all other significant data of the present analysis the publication bias assessment yielded low values and, according to Rosenthal,34 the finding of significance was not robust against the possibility of unpublished negative studies. Despite the favorable evidence provided by the present meta-analysis, more information is needed VOLUME 51, NO. 1, 2000

before recommending the use of SS or FOY in every patient undergoing ERCP. Indeed, in most cases post-procedure pancreatitis is relatively mild and resolves spontaneously in a few days, whereas severe pancreatic injury occurs rarely. For example, in the largest prospective study on the prevention of AP after ERCP,4 severe necrotizing pancreatitis developed in only 5 of 210 control patients. Moreover, the most appropriate duration of treatment with these agents should also be clarified. Long-term infusion (12 to 24 hours) of therapeutic agents, as carried out in several studies,4,10,12,14,16,18,21 may be impractical for elective ERCP as an outpatient procedure. Finally, the generalized treatment of all patients undergoing ERCP is unlikely to be cost-effective. Because the risk factors for ERCP-induced complications have been identified,1-3 it seems reasonable that treatment be reserved to those patients who will benefit the most. Additional studies comparing the efficacy of short-term infusion of SS versus FOY in patients at high-risk for post-ERCP complications are warranted. DISCLOSURE STATEMENT The present meta-analysis was not supported by pharmaceutical companies or private or institutional grants. REFERENCES 1. Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PG, et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996;335:909-18. 2. Sherman S, Lehman G. ERCP and endoscopic sphincterotomy-induced pancreatitis. Pancreas 1991;6:350-67. 3. Cotton PB, Lehman G, Vennes J, Geenen GE, Russell RC, Meyers WC, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383-93. 4. Cavallini G, Tittobello A, Frulloni L, Masci E, Mariani A, Di GASTROINTESTINAL ENDOSCOPY

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Francesco V, et al. Gabexate for the prevention of pancreatic damage related to endoscopic retrograde cholangiopancreatography. N Engl J Med 1996;335:919-23. Kuno N, Kasugai T, Oguri T, Matsuura A. Study on prevention of complication associated with endoscopic retrograde cholangiopancreatography (ERCP): a controlled trial of a new protease inhibitor, FOY, in hyperamylasemia following endoscopic retrograde cholangiopancreatography. Gendai Iryo 1978;10:571-5. Hajiro K, Tsujimura D, Inoue R, Yamamoto H, Yamamoto T. Effect of FOY on hyperamylasemia after endoscopic retrograde cholangiopancreatography. Gendai Iryo 1978;10:1375-9. Shimizu Y, Takahashi H, Deura M, Aizawa Y, Zenitani M, Akiba M, et al. Prophylactic effects of preoperative administration of Gabexate Mesilate (FOY) on post-ERCP pancreatitis. Gendai Iryo 1979;11:540-4. Salamon V, Kuntz HD, May B. Wirkung des synthetischen proteinase-inhibitors FOY auf die hyperamylasamie nach ERP. In: Grozinger KH, Schrey A, Wabnitz RW, editors. Proteinasen-inhibition, FOY workshop, 1981. Dusseldorf, Germany: Wolf G & Sohn; 1982. p. 132-5. Benini L, Angelini G, Lavarini E, Brocco G, Cavallini G, Merigo F, et al. Effect of a new enzyme inhibitor (Gabexate Mesilate- FOY) on hyperenzymemia induced by ERCP. A double blind study [abstract]. Digestion 1985;32:A165. Borsch G, Bergbauer M, Nebel W, Sabin G. Der einfluß von somatostatin auf die amylasespiegel und pankreatitistrate nach ERCP. Med Welt 1984;35:109-12. Cicero GF, Lauger R, Sahel J, Manganaro M, Sarles H. Effect of somatostatin on clinical, biochemical and morphological changes following ERCP. Ital J Gastroenterol 1985;17:265-8. Tyden G, Nyberg B, Sonnenfeld T, Thulin L. Effect of somatostatin on hyperamylasemia following endoscopic pancreatography. Acta Chir Scand 1986;530:43-5. Bordas M, Toledo V, Mondelo F, Rodès J. Prevention of pancreatic reactions by bolus somatostatin administration in patients undergoing endoscopic retrograde cholangio-pancreatography and endoscopic sphincterotomy. Hormone Res 1988;29:106-8. Testoni PA, Masci E, Bagnolo F, Tittobello A. Endoscopic papillo-sphincterotomy: prevention of pancreatic reaction by somatostatin. Ital J Gastroenterol 1988;20:70-3. Saari A, Kivilaakso E, Schroder T. The influence of somatostatin on pancreatic irritation after pancreatography. An experimental and clinical study. Surg Res Comm 1988;2: 271-8. Flati G, Porowska B, Negro P, Flati D, Chiarinelli MG, Carboni M. Efecto de la somatostatina sobre las secuelas de la colangiopancreatografia retrograda endoscopica. Rev Esp Enf Ap Digest 1988,74:17-9. Deschner K, Kalloo A, Collen M, Cattau EL, Maher KA, Fleischer DE, et al. Somatostatin: an evaluation of its utility as adjunctive medication for ERCP [abstract]. Gastrointest Endosc 1989;35:A149. Guelrud M, Mendoza S, Viera L, Gelrud D. Somatostatin prevents acute pancreatitis after pancreatic duct sphincter hydrostatic balloon dilation in patients with idiopathic recurrent pancreatitis. Gastrointest Endosc 1990;36:44-7. Persson B, Slezak P, Efendic S, Haggmark A. Can somatostatin prevent injection pancreatitis after ERCP? Hepatogastroenterology 1992;39:259-61. Bordas JM, Toledo-Pimentel V, Llach J, Montserrat E, Mondelo F, Gines A, et al. Effects of bolus somatostatin in preventing pancreatitis after endoscopic pancreatography: results of a randomized study. Gastrointest Endosc 1998;47: 230-4. GASTROINTESTINAL ENDOSCOPY

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21. Poon RTP, Yeung C, Lo CM, Yuen WK, Liu CL, Fan ST. Prophylactic effect of Somatostatin on post-ERCP pancreatitis: a randomized controlled trial. Gastrointest Endosc 1999;49: 593-8. 22. Tulassay Z, Papp J. The effect of long acting somatostatin analogue on enzyme changes after endoscopic pancreatography. Gastrointest Endosc 1991;37:48-50. 23. Sternlieb JM, Aronchick CA, Retig JN, Dabezies M, Saunders F, Goosenberg E, et al. A multicenter, randomized, controlled trial to evaluate the effect of prophylactic octreotide on ERCP-induced pancreatitis. Am J Gastroenterol 1992;87: 1561-6. 24. Binmoeller KF, Harris AG, Dumas R, Grimaldi C, Delmont JP. Does the somatostatin analogue octreotide protect against ERCP induced pancreatitis? Gut 1992;33:1129-33. 25. Russo A, Virgilio C, Aprile G, Magnano A, Cosentino S. Influenza dell’octreotide sulla reazione pancreatica indotta da colangiopancreatografia retrograda. Giorn Ital End Dig 1992;15:139-45. 26. Testoni PA, Lella F, Bagnolo F, Buizza M, Colombo E. Controlled trial of different dosages of octreotide in the prevention of hyperamylasemia induced by endoscopic papillosphincterotomy. Ital J Gastroenterol 1994;26:431-6. 27. Arcidiacono R, Gambitta P, Rossi A, Grosso C, Bini M, Zanasi G. The use of a long-acting somatostatin analogue (octreotide) for prophylaxis of acute pancreatitis after endoscopic sphincterotomy. Endoscopy 1994;26:715-8. 28. Baldazzi G, Conti C, Spotti EG, Arisi GP, Scevola M, Gobetti F, et al. Profilassi della pancreatite acuta post ERCP con octreotide. Giorn Chir 1994;15:359-62. 29. Testoni PA, Lella F, Bagnolo F, Caporuscio S, Cattani L, Colombo E, et al. Long term prophylactic administration of octreotide reduces the rise in serum amylase after endoscopic procedures on Vater’s papilla. Pancreas 1996;13:61-5. 30. Tulassay Z, Dobronte Z, Pronai L, Zagoni T, Juhasz L. Octreotide in the prevention of pancreatic injury associated with endoscopic cholangiopancreatography. Aliment Pharmacol Ther 1998;12:1109-12. 31. Arvanitidis D, Hatzipanayiotis J, Koutsounopoulos G, Frangou E. The effect of Octreotide on the prevention of acute pancreatitis and hyperamylasemia after diagnostic and therapeutic ERCP. Hepato-gastroenterology 1998;45:248-52. 32. Hasselblad V, McCrory D. Meta-analytic tools for medical decision making: a practical guide. Med Decis Making 1995; 15:81-96. 33. Andriulli A, Leandro G, Clemente R, Festa V, Caruso N, Annese V, et al. Metaanalysis of somatostatin, octreotide, and gabexate mesilate in the therapy of acute pancreatitis. Aliment Pharmacol Ther 1998;12:237-45. 34. Rosenthal R. Meta-analytic procedures for social research. Beverly Hills: Sage; 1984. 35. Binmoeller KF, Dumas R, Harris AG, Delmont JP. Effect of somatostatin analog octreotide on human sphincter of Oddi. Dig Dis Sci 1992;37:773-7.

APPENDIX With Galbraith radial plots, the numerical value of OR in a given study can be read-off by extrapolating a line from (0.0) through (x,y) to the circular scale drawn. The approximate 95% confidence interval (CI) can be obtained by drawing a line from (0.0) through (x, y+2) and (x, y–2). Studies with large standard error (∆), falling near the origin of the radial plot, are less precise and informative than those with small standard errors (∆) which fall away from the origin. Lines at y = 0 represent equivalent risk VOLUME 51, NO. 1, 2000

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A Andriulli, G Leandro, G Niro, et al.

(OR = 1) between treated and untreated patients. Lines at y = βx ± 2 show the “homogeneity area.” Finally, the pooled OR with 95% CI, obtained by the Peto’s method, is also shown in the radial plot. We have taken the meta-

analytical result as evidence of treatment efficacy if pooled ORs were significantly reduced, if one or more studies showed significant benefit, and if there was no clinical or statistical heterogeneity across the trials.

Figure 1A

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VOLUME 51, NO. 1, 2000

GASTROINTESTINAL ENDOSCOPY

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