Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063362) titled 'Safety of continuous suturing for pancreatic duct-to-jejunum anastomosis in pancreaticoduodenectomy' on Oct. 21.

Study Type: Interventional

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

Primary Sponsor: Institute - Hyogo Medical University

Condition: Condition - Pancreatic head and periampullary tumors Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To prospectively evaluate the safety and feasibility of continuous-suture duct-to-mucosa pancreaticojejunostomy in pancreaticoduodenectomy (PD), focusing on the incidence of clinically relevant postoperative pancreatic fistula (CR-POPF) within 90 days after surgery. The data will be used to estimate the effect size, calculate the sample size, and standardize the technique for a future multicenter randomized controlled trial comparing continuous and interrupted sutures. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duct-to-mucosa pancreaticojejunostomy in pancreaticoduodenectomy (including pylorus-preserving and subtotal stomach-preserving PD; open, laparoscopic, or robot-assisted) is performed with continuous sutures using 5-0 PDS. If the surgeon judges continuous suturing to be difficult or unsafe during surgery, the anastomosis is immediately converted to interrupted sutures.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients scheduled for pancreaticoduodenectomy (including pylorus-preserving and subtotal stomach-preserving PD) with reconstruction by duct-to-mucosa pancreaticojejunostomy 2) Aged 18 years or older at the time of consent 3) Written informed consent obtained from the patient 4) Regardless of disease (benign or malignant) or approach (open, laparoscopic, or robot-assisted) Key exclusion criteria - 1) Patients scheduled for pancreatic reconstruction other than duct-to-mucosa pancreaticojejunostomy, such as pancreaticogastrostomy or pancreatic duct ligation 2) Patients scheduled for total pancreatectomy 3) Patients requiring combined resection of major adjacent organs, such as hepatectomy or colectomy (combined resection of the portal vein/superior mesenteric vein and partial resection of adjacent organs are allowed) 4) Patients expected to require arterial reconstruction, such as of the common hepatic artery or celiac artery 5) Patients with severe ischemic heart disease 6) Patients with liver cirrhosis or active hepatitis 7) Patients with dyspnea requiring oxygen therapy due to interstitial pneumonia, pulmonary fibrosis, or other conditions 8) Patients on dialysis for chronic renal failure 9) Patients with active synchronous cancer considered to affect adverse events or overall survival 10) Patients on long-term oral steroids considered to affect adverse events 11) Patients who cannot receive either iodinated or gadolinium-based contrast agents due to severe drug allergy 12) Patients judged to lack the capacity to consent 13) Patients with psychosis or psychiatric symptoms that make participation in the study difficult 14) Other patients judged inappropriate by the principal investigator or sub-investigators Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 11 Month 01 Day Anticipated trial start date - 2026 Year 12 Month 01 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072523

Disclaimer: Curated by HT Syndication.