NCT02588066

Pancreatoduodenectomy With or Without Ligamentum Teres Wrap Around Gastroduodenal Artery Stump for Prevention of Pancreatic Hemorrhage

Pancreatoduodenectomy With or Without Prophylactic Ligamentum Teres Hepatic Wrap Around the Gastroduodenal Artery Stump for Prevention of Pancreatic Hemorrhage - Panda - Multicentric Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate, whether a prophylactic wrapping of the gastroduodenal artery stump with the ligamentum teres or falciform hepatic (embryological structures, covered with peritoneum that do not have relevant meaning for adults) can reduce the incidence of arrosion bleeding during surgery. Thus a surgical technique is evaluated prospectively.

Detailed description

Pancreatoduodenectomy is a standard surgical procedure for resection of tumors of the pancreatic head and neck, and for selected patients with chronic pancreatitis. A postoperative pancreatic fistula (POPF) is a severe and frequent complication that may lead to a potentially letal arrosion hemorrhage from the stump of the gastroduodenal artery (GDA). Aim of the study is to evaluate the prophylactic wrapping of the GDA stump using the falciform hepatic ligament during the index operation. The null hypothesis is that prophylactic wrapping does not decrease the incidence of arrosion hemorrhage from the GDA stump. The study is designed as a randomized, single-blinded, controlled, multicenter trial.

Conditions

• Pancreatoduodenectomy

Interventions

Type	Name	Description
PROCEDURE	Ligamentum teres/falciform-plasty	Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy

Timeline

• Start date: 2015-11-01
• Primary completion: 2020-06-01
• Completion: 2020-07-01
• First posted: 2015-10-27
• Last updated: 2021-02-05

Locations

1 site across 1 country: Germany