NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051230102

Registered date:21/09/2023

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedsuperficial duodenal epithelial tumor
Date of first enrollment02/10/2023
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)Subcutaneous administration of Octreotide

Outcome(s)

Primary OutcomeIncidence 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 OutcomeIncidence 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 maximumNot applicable
GenderBoth
Include criteriaDiagnosis 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 criteriaActive 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

Contact

Public contact
Name Yugo Kai
Address 1-69, Otemae 3-chome, Chuo-ku, Osaka, Japan Osaka Japan 541-8567
Telephone +81-6-6945-1181
E-mail yugo.kai@oici.jp
Affiliation Osaka International Cancer Institute
Scientific contact
Name Shunsuke Yoshii
Address 1-69, Otemae 3-chome, Chuo-ku, Osaka, Japan Osaka Japan 541-8567
Telephone +81-6-6945-1181
E-mail shunsuke.yoshii@oici.jp
Affiliation Osaka International Cancer Institute