NIPH Clinical Trials Search

The efficacy and safety of pancrelipase in patients undergoing adjuvant chemotherapy after gastrectomy: A multicenter, prospective, open-label study.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Cases of adjuvant chemotherapy administered after gastrectomy for Stage2 and 3 gastric cancer
Date of first enrollment	05/01/2026
Target sample size	100
Countries of recruitment
Study type	Interventional
Intervention(s)	LipaCreon administration. Follow the package insert and take 600 mg of pancrelipase orally three times a day immediately after meals.

Outcome(s)

Primary Outcome	Weight loss at 3 and 6 months postoperatively in patients who did not take oral nutritional supplements (ONS)
Secondary Outcome	Tolerability of postoperative adjuvant chemotherapy with or without oral nutritional support (ONS) Weight loss at 3 and 6 months postoperatively in patients receiving ONS Changes in quality of life during chemotherapy Stool consistency and frequency

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 85age old
Gender	Both
Include criteria	1. Cases in which the age at the time of consent was over 20 years old and under 85 years old 2. Cases in which gastric resection was performed as distal gastrectomy, pylorus-preserving gastrectomy, total gastrectomy, or Proximal gastrectomy 3.Cases with Eastern Cooperative Oncology Group Performance Status (PS) 0-2 4. Cases where written informed consent from the patient is obtained for participation in this study 5. Cases where oral intake is possible 6. Cases without postoperative complications (Clavien-Dindo classification 3 or higher) after gastrectomy 7. Cases where postoperative adjuvant chemotherapy for gastric cancer is scheduled to begin within 6 weeks postoperatively
Exclude criteria	1. Cases with the following serious complications Interstitial pneumonia, pulmonary fibrosis, severe emphysema, convulsive seizures and paroxysmal disorders, congestive heart failure classified as NYHA class II or higher, serious mental disorders, uncontrolled hypertension, uncontrolled diabetes, active bleeding, liver failure, renal failure 2.Patients with a history of cardiovascular disease or thromboembolism within the past 6 months prior to enrollment, or patients with arrhythmias requiring treatment 3. Cases with active infections 4. Cases deemed ineligible for study participation by the attending physician due to poor general condition 5. Cases where exocrine pancreatic insufficiency is suspected for reasons other than gastrectomy 6.Patients with a history of hypersensitivity to the components of LipaCreon 7. Patients with a history of hypersensitivity to porcine protein 8. Patients who are participating in or intend to participate in other clinical studies, excluding observational studies, while participating in this study. 9.Cases deemed to interfere with, restrict, or confuse the evaluation specific to the clinical study protocol 10. Researchers directly involved in this study or other clinical studies, or employees of the implementing medical institution 11. Patients who may be pregnant or who cannot consent to contraception