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

Technische Universität Dresden

Status: Completed

Conditions: Pancreatoduodenectomy

Treatments: Procedure: Ligamentum teres/falciform-plasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02588066

TW-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Index test

Experimental group

Description:

Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy

Treatment:

Procedure: Ligamentum teres/falciform-plasty

Reference test

No Intervention group

Description:

No Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy