Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061003) titled 'Duodenal Gel-immersion Endoscopic submucosal dissection for Large superficial non-ampullary duodenal epithelial lesions (D-GEL study)' on May 1.

Study Type: Observational

Primary Sponsor: Institute - Kyoto Prefectural University of Medicine

Condition: Condition - Superficial non-ampullary duodenal epithelial tumor Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To identify the safety and efficacy of gel immersion ESD for SNADET Basic objectives2 - Safety

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Patients have a lesion diagnosed as SNADET by endoscopic examination, including suspected cases, regardless of whether a biopsy has been performed, and are scheduled to undergo ESD. 2. The lesion is 20 mm or larger in size based on the preoperative endoscopic diagnosis. 3. Saline- or Gel-immersion observation has been performed during the preoperative endoscopic examination, and the lesion has been judged to be appropriate for treatment under gel immersion. 4. The patient is aged 20 years or older and younger than 90 years at the time of enrollment. 5. The patient has received a full explanation regarding participation in the study, and written informed consent has been obtained from the patient. Key exclusion criteria - 1. Lesions larger than 50 mm. 2. Lesions in which the resection area involves the pyloric ring or the major papilla. 3. Patients with a history of gastric or duodenal surgery. 4. Cases in which follow-up until 14 days after ESD is not feasible. 5. Cases considered inappropriate for study participation by the investigator. Target Size - 160

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 19 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2029 Year 04 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069808

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