NIPH Clinical Trials Search

A Randomized Trial on the Efficacy of Perioperative Octreotide in Endoscopic Papillectomy

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Ampullary tumor
Date of first enrollment	04/03/2026
Target sample size	58
Countries of recruitment
Study type	Interventional
Intervention(s)	Subcutaneous administration of Octreotide acetate

Outcome(s)

Primary Outcome	Incidence rate of postoperative complications (pancreatitis, hemorrhage, perforation) occurring within 30 days after endoscopic papillectomy
Secondary Outcome	1. Incidence of intraoperative complications 2. Incidence of all complications within 30 days postoperatively 3. Incidence of treatment-related adverse events 4. Duration of fasting 5. Length of hospital stay 6. Changes in blood glucose levels before and after octreotide acetate administration

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Diagnosis of duodenal adenoma or intramucosal adenocarcinoma by preoperative endoscopic forceps biopsy or endoscopic observation. In cases of adenocarcinoma, endoscopic observation or endoscopic ultrasound reveals that the cancer is confined to the mucosal layer. Age is 18 or over. No severe organ dysfunction. Performance Status (ECOG) is 0, 1 or 2. Written informed consent is obtained.
Exclude criteria	Poorly controlled diabetes mellitus. Continuous use of Cyclosporin or Bromocriptine. Active other organ cancer that cannot be cured. Severe psychiatric disease. Active infectious disease. Participating in other interventional study. Patients judged inappropriate by investigator or attending doctor.