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

Not Applicable

Completed

• Conditions: Pancreatoduodenectomy
• Interventions: Procedure: Ligamentum teres/falciform-plasty

• Registration Number: NCT02588066
• Lead Sponsor: Technische Universität Dresden

Brief 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.

Study Timeline

• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Study Start: 2015-11
• Primary Completion: 2020-06
• Study Completion: 2020-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Indication for elective open pancreatoduodenectomy (pylorus-preserving or classic) with pancreatojejunostomy for tumors, or cystic lesions of the pancreatic head, tumors of the distal bile duct, duodenum or for chronic pancreatitis
• american society of anesthesiologists classification I-III
• age ≥18 years
• given informed consent

Exclusion Criteria

• status post previous abdominal surgery with resection of the falciform ligament (e.g. hemihepatectomy)
• No reconstruction using a pancreatojejunostomy (e.g. pancreatogastrostomy)
• simultaneous visceral arterial resection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Index test	Ligamentum teres/falciform-plasty	Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy

Primary Outcome Measures

Name	Time	Method
Incidence of arrosion bleeding	>24 hours after partial pancreatoduodenectomy

Trial Locations

Locations (1)

Department of Surgery, University Hospital Dresden; 🇩🇪 Dresden, Germany