Efficacy of perioperative octreotid for endoscopic resection of superficial duodenal epithelial tumor

Phase 2

Recruiting

• Conditions: superficial duodenal epithelial tumor; duodenal neoplasm; D004379

• Registration Number: JPRN-jRCTs051230102
• Lead Sponsor: Yoshii Shunsuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Diagnosis of duodenal adenoma or intramucosal adenocarcinoma by preoperative endoscopic forceps biopsy or endoscopic observation
Tumor of the papilla of Vater or superficial non-ampullary duodenal epithelial tumors of 2 cm or larger in diameter and located at the anal side of supraduodenal angle
Age is 18 or over
No severe organ dysfunction
Performance Status (ECOG) is 0, 1 or 2
Written informed consent are obtained

Exclusion Criteria

Active other organ cancer that cannot be cured
Poorly controlled diabetes mellitus
Continuous use of Cyclosporin or Bromocriptine
Severe psychiatric disease
Active infectious disease
Pregnant or possibly pregnant
Participating in other interventional study
Patients judged inappropriate by investigator or attending doctor

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative adverse events within 28 days after procedure<br>Cohort A: postoperative (delayed) perforation or postoperative bleeding<br>Cohort B: postoperative (delayed) perforation, postoperative bleeding, or postoperative pancreatitis

Secondary Outcome Measures

Name	Time	Method
Incidence of intraoperative adverse events<br>Incidence of overall adverse events<br>Incidence of adverse events related to study drug<br>Fasting period<br>Length of hospital stay<br>Glycemic response to study drug