# 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

## TL;DR

This study will test if pancreatic enzyme replacement therapy helps reduce gastrointestinal symptoms in patients after gastric cancer surgery.

## Contribution

This is the first multicenter trial to evaluate PERT's efficacy specifically in post-gastrectomy patients.

## Key findings

- 204 patients will be randomized to PERT or control to assess gastrointestinal symptom incidence.
- Patient-reported outcomes and nutritional status will be used to evaluate PERT effectiveness.
- Results will guide evidence-based management of PEI after gastric cancer surgery.

## Abstract

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.

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.

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.

This study was registered with the Chinese Clinical Trial Registry (ChiCTR; registry number: ChiCTR2500102557). Date of registration: 16 May 2025.