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Clinical study on the effectiveness of pancreatic enzyme replacement therapy (PERT) in the treatment of gastrointestinal symptoms after gastric cancer surgery - multicenter, randomized controlled trial

Clinical study on the effectiveness of pancreatic enzyme replacement therapy (PERT) in the treatment of gastrointestinal symptoms after gastric cancer surgery - multicenter, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102557
Enrollment
Unknown
Registered
2025-05-16
Start date
2025-05-19
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Gastrointestinal symptoms after gastric cancer surgery

Interventions

Experimental group:PERT group
Control group:None

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.18~75 years old, male or female not limited; 2.There are gastric cancer or gastroesophageal junction (GEJ) cancer that have been confirmed histologically but have not received treatment, and histological examination confirms that they are mainly adenocarcinoma. Only Siewert III and Siewert II subjects who do not require combined thoracotomy are allowed to be enrolled in the study for gastroesophageal junction (GEJ) cancer; 3.Feasible radical resection for gastric cancer; 4.Not receiving prior treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 5.ECOG PS:0-1; 6.The main organ function is normal; 7.Prior to enrollment, the heart function was good, with no myocardial infarction within six months. Hypertension and other coronary heart diseases are currently within a controllable range; 8.Prior to enrollment, there were no other uncontrollable benign diseases such as lung, kidney, liver infections, etc; 9.The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;

Exclusion criteria

Exclusion criteria: 1. Other active malignant tumors within 5 years or at the same time. Localized tumors that had been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, could be enrolled. 2. History of pancreatic disease within half a year; 3. Distant metastasis confirmed by imaging or pathological examination, including but not limited to distant lymph node metastasis, liver metastasis, peritoneal metastasis, lung metastasis, bone metastasis, adrenal gland metastasis, central nervous system metastasis, leptomeningeal metastasis, spinal cord compression or leptomeningeal disease; 4. Myocardial infarction or uncontrolled arrhythmia (QTc interval >= 450 ms in men or >= 470 ms in women) within 6 months before enrollment (QTc interval calculated with Fridericia's formula); 5. Presence of NYHA class ?-? cardiac dysfunction or echocardiography: LVEF 10 mg/ day prednisone efficacy dose) or other immunosuppressive medications within 14 days before enrollment or during the study period. Patients were allowed, however, to use topical or inhaled steroids or adrenal-hormone-replacement therapy at a therapeutic dose of prednisone of 10mg or less per day in the absence of active autoimmune disease. 10. Known history of severe allergy to study excipients; 11. Known history of psychotropic substance abuse or drug use; Patients who had stopped drinking alcohol were eligible. 12. Patients with other severe, acute or chronic diseases that may increase the risk of participating in the study and the study medication, or who are judged by the investigators to be unsuitable for participating in the clinical study;

Design outcomes

Primary

MeasureTime frame
Gastrointestinal symptom score within 1 month after surgery;

Secondary

MeasureTime frame
Nutritional status;Hematological indicators;

Countries

China

Contacts

Public ContactXu Rui

Sichuan Cancer Hospital

1105331290@qq.com+86 28 85420501

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 13, 2026