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The impact of pancreatic enzyme replacement therapy on nutritional outcomes and chemotherapy tolerance after gastric cancer surgery: A multicenter randomized controlled study

The impact of pancreatic enzyme replacement therapy on nutritional outcomes and chemotherapy tolerance after gastric cancer surgery: A multicenter randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121873
Enrollment
Unknown
Registered
2026-04-07
Start date
2026-04-08
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Pancreatic enzyme replacement therapy group:The dosage will be individualized based on the patient's dietary fat content, typically 25,000–40,000 U of lipase taken with meals.
Control group:None

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 75 years old, regardless of gender. 2. Pathologically confirmed gastric adenocarcinoma and having undergone radical resection surgery (including total gastrectomy, proximal gastrectomy or distal gastrectomy). 3. Smooth postoperative recovery and resumption of oral feeding. 4. Undergone assessment of pancreatic exocrine function within 1 to 3 months after surgery and meeting at least one of the following criteria: (1)Fecal elastase-1 (FE-1) test value < 200 µg/g. (2) Abnormal result of ¹³C-mixed triglyceride breath test. 5. Fully understand this study and voluntarily sign the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of definite chronic pancreatitis, pancreatic resection surgery or biliary diseases affecting pancreatic function. 2. Concurrent severe heart, liver or kidney dysfunction or hematological diseases. 3. Women in pregnancy or lactation. 4. Presence of severe gastrointestinal obstruction or inability to tolerate oral medication due to other reasons. 5. Suffering from mental disorders or judged by the researcher to have poor compliance and likely unable to complete the study process.

Design outcomes

Primary

MeasureTime frame
Weight;

Secondary

MeasureTime frame
Hemoglobin;Serum albumin;

Countries

China

Contacts

Public ContactZhibo Yan

Qilu Hospital of Shandong University

zhiboyan@sdu.edu.cn+86 185 6008 5166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026