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 |
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Health condition(s) or Problem(s) studied | superficial duodenal epithelial tumor |
Date of first enrollment | 02/10/2023 |
Target sample size | 60 |
Countries of recruitment | |
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 |
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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 |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
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 |
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 |
shunsuke.yoshii@oici.jp | |
Affiliation | Osaka International Cancer Institute |