Tokyo, May 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061526) titled 'Omission of prophylactic intra-abdominal drainage after pancreatoduodenectomy: a prospective pilot safety study of a no-drain strategy' on May 20.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Juntendo University Graduate School of Medicine

Condition: Condition - Pancreatic cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to prospectively evaluate the safety of a no-drain strategy, in which prophylactic intra-abdominal drainage is omitted, in low-risk patients undergoing pancreatoduodenectomy. The primary outcome is the rate of invasive intra-abdominal reintervention within 30 days after surgery, and serious postoperative complications will also be assessed. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - In low-risk patients for postoperative pancreatic fistula, a no-drain strategy will be applied during pancreatoduodenectomy by omitting prophylactic intra-abdominal drainage. Postoperative management will follow a predefined safety protocol, including clinical assessment, laboratory tests, imaging when clinically indicated, and reintervention such as percutaneous drainage, interventional radiology, or reoperation when necessary.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Patients aged 20 to 85 years at the time of informed consent Patients with a main pancreatic duct diameter of 3 mm or greater on preoperative computed tomography Patients judged intraoperatively to have a hard pancreatic texture by surgical palpation Patients with an Acinar Score of 3 or greater at the pancreatic transection margin Patients who have received sufficient explanation about the study, fully understood its contents, and provided written informed consent voluntarily Key exclusion criteria - Patients with distant metastasis Patients with an operative time exceeding 8.5 hours Patients with intraoperative blood loss exceeding 500 mL Patients requiring concomitant vascular resection Patients undergoing pancreatoduodenectomy for diseases other than pancreatic cancer Patients judged by the principal investigator or subinvestigators to be unsuitable for participation in the study

Eligible patients are defined as those who meet all inclusion criteria and do not meet any of the exclusion criteria listed above. Target Size - 23

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 13 Day Date of IRB - 2026 Year 04 Month 13 Day Anticipated trial start date - 2026 Year 05 Month 20 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070403

Disclaimer: Curated by HT Syndication.