ArticleFrontiers in pharmacology2026
Efficacy of pancreatic enzyme replacement therapy (PERT) in the treatment of gastrointestinal symptoms after gastric cancer surgery: study protocol for a multicenter randomized controlled open-label trial.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: Pancreatic exocrine insufficiency (PEI), presenting as bloating or diarrhea, affects 26%-100% of patients after gastrectomy, delaying recovery and impairing quality of life. Pancreatic enzyme replacement therapy (PERT) is the standard PEI management, yet its efficacy after gastric cancer surgery remains controversial. This study evaluates PERT's effectiveness in alleviating postoperative gastrointestinal symptoms. Methods and Analysis: In this multicenter randomized controlled trial, 204 patients undergoing radical gastrectomy will be randomized 1:1 to PERT or control. The PERT group will receive Pancreatin Enteric-coated Capsules (containing 450 mg pancrelipase microgranules) three times daily with meals for 1 month post-discharge. The primary outcome is the incidence of gastrointestinal symptoms at 1 month post-surgery, assessed using the MD Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI-GI). Secondary outcomes include nutritional status and treatment compliance. Discussion: This protocol establishes a framework for definitively evaluating PERT in gastric cancer patients. Results will inform evidence-based PEI management, with significant implications for survivorship care. By integrating patient-reported outcomes and nutritional metrics, we aim to validate a patient-centered strategy optimizing functional recovery after curative resection. Clinical Trial Registration: This study was registered with the Chinese Clinical Trial Registry (ChiCTR; registry number: ChiCTR2500102557). Date of registration: 16 May 2025.
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