Trial reportJournal of gastroenterology2021
A randomised, multicentre trial of somatostatin to prevent clinically relevant postoperative pancreatic fistula in intermediate-risk patients after pancreaticoduodenectomy.
Trial report in Journal of gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03349424 (A Multi-center, Randomized, Controlled Study), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-center, Randomized, Controlled Study: Somatostatin Prevent Post-operation Pancreatic Fistula (POPF) in Intermediate Risk Patients After Pancreaticoduodenectomy
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.
- Preventing pancreatic fistula following pancreatectomy: meta-analysis of randomized clinical trials.BJS open · 2026Pooled it
- Pooled it
- Somatostatin-analog effect on pancreatic fistula after radical gastrectomy: a pilot randomized controlled trial.Journal of cancer research and clinical oncology · 2023Trial
- A randomized controlled trial evaluating effects of prophylactic irrigation-suction near pancreaticojejunostomy on postoperative pancreatic fistula after pancreaticoduodenectomy.Langenbeck's archives of surgery · 2023Trial
- Reporting Standards and Quality Assurance Methods for Pancreatoduodenectomy in Randomised Controlled Trials: A Structured Narrative Review.Journal of clinical medicine · 2026Review
- Somatostatin and its analogs in the management of postoperative pancreatic fistulas: A comprehensive review.World journal of gastrointestinal surgery · 2026Review
- [Clinical Practice and Quality Control Strategies for Complex Minimally Invasive Pancreatic Surgery].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2025Review
- Risk Factors For Progression From Biochemical Leak to Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy. The Key of the Lock: Prognostic Nutritional Index.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2024Article
- Computed tomography-based radiomics and body composition analysis for predicting clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy.Gland surgery · 2024Article
- Machine learning models and nomogram based on clinical, laboratory profiles and skeletal muscle index to predict pancreatic fistula after pancreatoduodenectomy.Gland surgery · 2024Article
- Predictive Factors for Delayed Gastric Emptying After Pancreatoduodenectomy: A Swedish National Registry-Based Study.World journal of surgery · 2023Article
- Mismatch of populations between randomised controlled trials of perioperative interventions in major abdominal surgery and current clinical practice.Perioperative medicine (London, England) · 2023Review
- Perioperative Drug Treatment in Pancreatic Surgery-A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2023Review
- Effect of postoperative utilization of somatostatin on clinical outcome after definitive surgery for duodenal fistula.European journal of medical research · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundProphylactic somatostatin to reduce the incidence of clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy remains controversial. We assessed the preventive efficacy of somatostatin on clinically relevant postoperative pancreatic fistula in intermediate-risk patients who underwent pancreaticoduodenectomy at pancreatic centres in China.
methodsIn this multicentre, prospective, randomised controlled trial, we used the updated postoperative pancreatic fistula classification criteria and cases were confirmed by an independent data monitoring committee to improve comparability between centres. The primary endpoint was the rate of clinically relevant postoperative pancreatic fistula within 30 days after pancreaticoduodenectomy.
resultsEligible patients (randomised, n = 205; final analysis, n = 199) were randomised to receive postoperative intravenous somatostatin (250 μg/h over 120 h; n = 99) or conventional therapy (n = 100). The primary endpoint was significantly lower in the somatostatin vs control group (n = 13 vs n = 25; 13% vs 25%, P = 0.032). There were no significant differences for biochemical leak (P = 0.289), biliary fistula (P = 0.986), abdominal infection (P = 0.829), chylous fistula (P = 0.748), late postoperative haemorrhage (P = 0.237), mean length of hospital stay (P = 0.512), medical costs (P = 0.917), reoperation rate (P > 0.99), or 30 days' readmission rate (P = 0.361). The somatostatin group had a higher rate of delayed gastric emptying vs control (n = 33 vs n = 21; 33% vs 21%, P = 0.050).
conclusionsProphylactic somatostatin treatment reduced clinically relevant postoperative pancreatic fistula in intermediate-risk patients after pancreaticoduodenectomy.
trial registrationNCT03349424.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.