Clinical Trial: The Usefulness of Gel Immersion Endoscopy in Patients with Pancreaticojejunostomy Anastomotic Stricture: A Multicenter Prospective Observational Study (Japan)

Tokyo, Sept. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063085) titled 'The Usefulness of Gel Immersion Endoscopy in Patients with Pancreaticojejunostomy Anastomotic Stricture: A Multicenter Prospective Observational Study' on Sept. 28.

Study Type: Observational

Primary Sponsor: Institute - Iwata City Hospital

Condition: Condition - Pancreaticojejunostomy anastomotic stricture Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Pancreaticojejunostomy anastomotic stricture (PJAS) is a late complication that can occur after pancreaticoduodenectomy and may lead to symptoms such as pancreatitis. Endoscopic treatment is often attempted via the anastomosis, but identifying the site can be challenging, and success rates are relatively low. Gel immersion endoscopy (GIE) has recently been introduced to improve visibility during endoscopic procedures. This technique has shown promise in enhancing the identification of the anastomosis site. However, its effectiveness in PJAS has not been evaluated in a prospective study. This multicenter prospective observational study aims to assess the usefulness of GIE during endoscopic treatment for PJAS. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Inclusion Criteria

1) Symptomatic PJAS after pancreaticoduodenectomy (PD) 2) Age 20 years or older 3) Provided with sufficient explanation about the study and obtained written informed consent from the patient Key exclusion criteria - Exclusion Criteria

1) History of treatment for PJAS 2) Pregnant or suspected pregnancy 3) Any other condition judged inappropriate for participation by the principal investigator or sub-investigators Target Size - 20

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 04 Month 01 Day Date of IRB - 2025 Year 06 Month 10 Day Anticipated trial start date - 2025 Year 06 Month 10 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066918

Disclaimer: Curated by HT Syndication.