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

JRCT ID: jRCTs051230102

Registered date:21/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: superficial duodenal epithelial tumor
• Date of first enrollment: 02/10/2023
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Subcutaneous administration of Octreotide

Outcome(s)

Primary Outcome

Incidence of postoperative adverse events within 28 days after procedure
Cohort A: postoperative (delayed) perforation or postoperative bleeding
Cohort B: postoperative (delayed) perforation, postoperative bleeding, or postoperative pancreatitis

Secondary Outcome

Incidence of intraoperative adverse events
Incidence of overall adverse events
Incidence of adverse events related to study drug
Fasting period
Length of hospital stay
Glycemic response to study drug

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
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

Exclude 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

Related Information

• Primary Sponsor: Yoshii Shunsuke