Somatostatin-based therapies for external gastrointestinal fistulas: Updated meta-analysis of randomized clinical trials

doi:10.4292/wjgpt.v16.i4.111889

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World Journal of Gastrointestinal Pharmacology and Therapeutics

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Meta-Analysis

World J Gastrointest Pharmacol Ther. Dec 5, 2025; 16(4): 111889
Published online Dec 5, 2025. doi: 10.4292/wjgpt.v16.i4.111889

Somatostatin-based therapies for external gastrointestinal fistulas: Updated meta-analysis of randomized clinical trials

Marcelo Augusto Fontenelle Ribeiro Junior, Lucas Fontenelle Vieira, Husna Irfan Thalib, Syed Fouzaan Albeez, Faaleha Heba Fakruddin, Ahmed Mirza Zafar Baig, Hajira Mohammed, Syeda Nafeesa Hashim, Atika Abdul Rauf Khan, Rafael Dib Possiedi

Marcelo Augusto Fontenelle Ribeiro Junior, Rafael Dib Possiedi, Department of Surgery, R Adams Cowley Shock Trauma Center, University of Maryland, Baltimore, MD 21201, United States

Marcelo Augusto Fontenelle Ribeiro Junior, Department of Surgery, Pontifical Catholic University of São Paulo - Campus Sorocaba, Sorocaba 18030070, Sao Paulo, Brazil

Lucas Fontenelle Vieira, Department of Surgery, Florida Atlantic University Charles E Schmidt College of Medicine, Boca Raton, FL 33431, United States

Husna Irfan Thalib, Syed Fouzaan Albeez, Faaleha Heba Fakruddin, Ahmed Mirza Zafar Baig, Hajira Mohammed, Syeda Nafeesa Hashim, Atika Abdul Rauf Khan, General Medicine Practice Program, Batterjee Medical College, Jeddah 21442, Makkah al Mukarramah, Saudi Arabia

Author contributions: Ribeiro Junior MAF and Possiedi RD provide the conception and design of the study; Possiedi RD, Thalib HI, Albeez SF, Fakruddin FH, Baig AMZ, Mohammed H, Hashim SN, Khan AAR, and Vieira LF contributed to the data curation, formal analysis, investigations; Ribeiro Junior MAF and Possiedi RD contributed to the administration, resources, supervision validation and visualization; Ribeiro Junior MAF and Possiedi RD contributed to writing the original draft and reviewing the drafts; Ribeiro Junior MAF provision of final approval of the version of the article to be published; All authors have read and approved the final manuscript.

Conflict-of-interest statement: All authors declare no conflicts of interest for this article.

PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.

Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/

Corresponding author: Marcelo Augusto Fontenelle Ribeiro Junior, MD, PhD, Chief Physician, Professor, Senior Researcher, Department of Surgery, R Adams Cowley Shock Trauma Center, University of Maryland, 22 South Greene Street, Baltimore, MD 21201, United States. mrfibeiro@som.umaryland.edu

Received: July 14, 2025
Revised: August 15, 2025
Accepted: November 10, 2025
Published online: December 5, 2025
Processing time: 146 Days and 22.1 Hours

Abstract

BACKGROUND

External gastrointestinal fistulas (EGIFs) are serious postoperative complications associated with prolonged hospital stays, sepsis, malnutrition, and high mortality rates. Reducing gastrointestinal secretions with somatostatin or its analogues may facilitate fistula closure. The clinical effectiveness of these therapies, however, remains uncertain.

AIM

To investigate the effectiveness of somatostatin-based therapy for EGIFs.

METHODS

A systematic review and meta-analysis (Prospero CRD420251054344) of nine randomized controlled trials (442 patients) compared somatostatin-based therapies with standard care in tertiary care settings. Protocols included somatostatin, octreotide, or lanreotide, administered at various dosages (250 micrograms/hour intravenous infusion or 100 micrograms subcutaneous injection three times daily) for 7 to 56 days. Primary outcomes were fistula closure rates and time to closure. Secondary outcomes were hospital length of stay, complications, need for surgical intervention, and mortality. Mean differences and risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using random-effects models. Risk of bias was assessed with the Cochrane RoB 2 tool.

RESULTS

There was no statistically significant difference in closure rate (RR: 1.11, 95%CI: 0.95-1.28, P = 0.19, I² = 0%) between 134/193 patients receiving somatostatin-based therapy and 99/170 control patients. Time to closure was reduced by 6.16 days (mean difference -6.16, 95%CI: -7.44 to -4.88, P < 0.001, I² = 0%) in 126 patients in intervention group vs 114 in control group. Hospital stay was shortened by 4.00 days (mean difference -4.00, 95%CI: -7.99 to -0.01, P = 0.05, I² = 0%) in 56 vs 62 patients. There were no differences in complications (RRs: 0.76, 95%CI: 0.55-1.05), need for surgical intervention (RRs: 0.67, 95%CI: 0.38-1.19), or mortality (RRs: 0.77, 95%CI: 0.44-1.35). Limitations include small sample sizes, heterogeneity in treatment regimens, and inconsistent outcome definitions, which may affect generalizability. Limited data for some outcomes, such as hospital stay, and exclusion of some datasets for methodological reasons reduced statistical power.

CONCLUSION

Somatostatin-based therapies did not significantly improve fistula closure rates but were associated with shorter time to closure and hospital stay. Mortality, complications, and surgical intervention requirements remained unchanged, suggesting that these therapies may serve only as an adjunctive option in selected patients.

Keywords: Enterocutaneous fistula; Somatostatin; Octreotide; Meta-analysis; Randomized controlled trials; Time to closure; Length of hospital stay; Conservative treatment; Gastrointestinal surgery

Core Tip: This meta-analysis of nine randomized controlled trials found that somatostatin and its analogues do not increase spontaneous closure rates of external gastrointestinal fistulas compared to standard care. However, treatment significantly shortens hospital stay and time to closure. These benefits suggest that somatostatin-based therapy may be useful as an adjunct in selected patients requiring faster recovery and reduced hospitalization.