Trial reportAlimentary pharmacology & therapeutics2013
Randomised clinical trial: a 1-week, double-blind, placebo-controlled study of pancreatin 25 000 Ph. Eur. minimicrospheres (Creon 25000 MMS) for pancreatic exocrine insufficiency after pancreatic surgery, with a 1-year open-label extension.
Trial report in Alimentary pharmacology & therapeutics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02985801 (Pancreatic Enzyme Replacement Therapy), which is not on this map. Cited by 33 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Pancreatic Enzyme Replacement Therapy (PERT) for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
Who cites it
33 citing papers in PubMed, 5 syntheses or guidelines pooled it, 79 citations in OpenAlex.
- Clinical Efficacy and Safety of Treatments for Exocrine Pancreatic Insufficiency: A Systematic Literature Review.Digestion · 2025Pooled it
- Brazilian consensus- and evidence-based recommendations in the diagnosis and treatment of pancreatic exocrine insufficiency in patients after digestive surgeries. Position paper of six brazilian medical societies of surgery.Arquivos brasileiros de cirurgia digestiva : ABCD = Brazilian archives of digestive surgery · 2025Pooled it
- Exocrine Pancreatic Insufficiency Dosing Guidelines for Pancreatic Enzyme Replacement Therapy Vary Widely Across Disease Types.Digestive diseases and sciences · 2024Pooled it
- Contribution of pancreatic enzyme replacement therapy to survival and quality of life in patients with pancreatic exocrine insufficiency.World journal of gastroenterology · 2019Pooled it
- Exocrine pancreatic insufficiency in adults: a shared position statement of the Italian Association for the Study of the Pancreas.World journal of gastroenterology · 2013Guideline
- Cost-effectiveness analysis of pancreatic enzyme replacement therapy in patients with pancreatic exocrine insufficiency in China.World journal of gastrointestinal oncology · 2025Article
- Canadian National Pancreas Conference 2023: A Review of Multidisciplinary Engagement in Pancreatic Cancer Care.Current oncology (Toronto, Ont.) · 2024Article
- Impact of pancreatic ductal occlusion on postoperative outcomes in pancreatic head cancer patients undergoing neoadjuvant therapy.Journal of gastroenterology · 2024Article
- Symptoms, burden, and unmet needs of patients living with exocrine pancreatic insufficiency: a narrative review of the patient experience.BMC gastroenterology · 2024Review
- Review
- Pancreatic Dysfunction and Reduction in Quality of Life Is Common After Pancreaticoduodenectomy.Digestive diseases and sciences · 2023Article
- Perioperative Drug Treatment in Pancreatic Surgery-A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2023Review
- Article
- Risk factors deteriorating severe exocrine pancreatic insufficiency measured by stool elastase after pancreatoduodenectomy and the risk factors for weight loss.Annals of surgical treatment and research · 2022Article
- Consensus for the management of pancreatic exocrine insufficiency: UK practical guidelines.BMJ open gastroenterology · 2021Review
- Review
- Differential Diagnosis and Management of Diarrhea in Patients with Neuroendocrine Tumors.Journal of clinical medicine · 2020Review
- Pancreatic exocrine insufficiency after pancreaticoduodenectomy: Current evidence and management.World journal of gastrointestinal pathophysiology · 2020Review
- Pancreatic Exocrine Insufficiency as a Complication of Gastrointestinal Surgery and the Impact of Pancreatic Enzyme Replacement Therapy.Digestive diseases (Basel, Switzerland) · 2020Review
- Long-Term Endocrine and Exocrine Insufficiency After Pancreatectomy.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 6 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPancreatic exocrine insufficiency (PEI) often occurs following pancreatic surgery.
aimTo demonstrate the superior efficacy of pancreatin 25 000 minimicrospheres (Creon 25000 MMS; 9-15 capsules/day) over placebo in treating PEI after pancreatic resection.
methodsA 1-week, double-blind, randomised, placebo-controlled, parallel-group, multicentre study with a 1-year, open-label extension (OLE). Subjects ≥18 years old with PEI after pancreatic resection, defined as baseline coefficient of fat absorption (CFA) <80%, were randomised to oral pancreatin or placebo (9-15 capsules/day: 3 with main meals, 2 with snacks). In the OLE, all subjects received pancreatin. The primary efficacy measure was least squares mean CFA change from baseline to end of double-blind treatment (ancova).
resultsAll 58 subjects randomised (32 pancreatin, 26 placebo) completed double-blind treatment and entered the OLE; 51 completed the OLE. The least squares mean CFA change in the double-blind phase was significantly greater with pancreatin vs. placebo: 21.4% (95% CI: 13.7, 29.2) vs. -4.2% (-12.8, 4.5); difference 25.6% (13.9, 37.3), P < 0.001. The mean ± s.d. CFA increased from 53.6 ± 20.6% at baseline to 78.4 ± 20.7% at OLE end (P < 0.001). Treatment-emergent adverse events occurred in 37.5% subjects on pancreatin and 26.9% on placebo during double-blind treatment, with flatulence being the most common (pancreatin 12.5%, placebo 7.7%). Only two subjects discontinued due to treatment-emergent adverse events, both during the OLE.
conclusionsThis study demonstrates superior efficacy of pancreatin 25 000 over placebo in patients with PEI after pancreatic surgery, measured by change in CFA. Pancreatin was generally well tolerated at the high dose administered (EudraCT registration number: 2005-004854-29).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.