Tokyo, Aug. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062441) titled 'A Study of the Outcomes and Safety of ESD Including the Papilla for Duodenal Tumors' on Aug. 2.

Study Type: Observational

Primary Sponsor: Institute - Mie University

Condition: Condition - Ampullary or papilla-involving duodenal epithelial neoplasms Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To prospectively evaluate the efficacy of endoscopic submucosal dissection including the papilla (ESDIP) for ampullary neoplasms or duodenal epithelial neoplasms involving the major duodenal papilla, using the R0 resection rate as the primary outcome. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - To be eligible for participation in this study, patients must meet all of the following criteria: 1.Aged 18 years or older at the time of obtaining informed consent. 2.A lesion diagnosed or suspected, based on endoscopic examination or biopsy findings, to be a tumor of the major duodenal papilla or a duodenal epithelial tumor involving the major duodenal papilla. 3.A lesion suspected, based on preoperative biopsy or endoscopic findings, to be an adenoma, high-grade dysplasia, carcinoma arising in an adenoma, intramucosal carcinoma, or superficial carcinoma limited to T1a. 4.No evidence of definite pancreatic invasion, invasion into or beyond the duodenal muscularis propria, lymph node metastasis, or distant metastasis on preoperative examinations performed as part of routine clinical practice, including endoscopy, endoscopic ultrasonography (EUS), intraductal ultrasonography (IDUS), computed tomography (CT), and magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP). 5.Scheduled to undergo ESD as part of routine clinical practice and considered by the treating physician to be technically amenable to endoscopic resection. 6.Eastern Cooperative Oncology Group Performance Status of 0-2. 7.Able to undergo follow-up for 3 years after treatment. 8.Written informed consent to participate in this study provided voluntarily by the patient after receiving an adequate explanation of the study and fully understanding its contents. Key exclusion criteria - Patients who meet any of the following criteria are ineligible for participation in this study: 1.Preoperative evaluation suggests invasive carcinoma of T1b or deeper, definite pancreatic invasion, invasion into or beyond the duodenal muscularis propria, lymph node metastasis, or distant metastasis. 2.Extensive intraductal extension into the bile duct or pancreatic duct is present, and complete endoscopic resection is considered difficult by the treating physician. 3.Previous surgical or endoscopic resection of the major duodenal papilla is considered likely to interfere with the assessment of safety or efficacy in this study. 4.Appropriate perioperative management of antithrombotic agents, including interruption, continuation, or resumption of treatment, is considered difficult. 5.A severe bleeding tendency is present. 6.A severe infection requiring systemic treatment is present. 7.Unstable angina is present, or there is a history of myocardial infarction within the preceding 6 months. 8.A respiratory disorder requiring continuous oxygen therapy is present. 9.Severe hepatic or renal failure is present, and the patient is considered to be at high risk from ESD or sedation/anesthesia. 10.Poorly controlled hypertension, diabetes mellitus, or another serious comorbidity is present, making participation in the study difficult. 11.The patient is pregnant, breastfeeding, or may be pregnant. 12. Psychosis, psychiatric symptoms, dementia, or another condition is present that is considered likely to impair participation in the study, understanding of the informed consent process, or adherence to the follow-up schedule. 13.The principal investigator or a subinvestigator considers the patient unsuitable for participation in the study for any other reason. Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 07 Month 14 Day Date of IRB - 2026 Year 07 Month 31 Day Anticipated trial start date - 2026 Year 08 Month 02 Day Last follow-up date - 2032 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071460

Disclaimer: Curated by HT Syndication.