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

Pancreatoduodenectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588066
• Other study ID #: TW-002
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: July 2020

Study information

• Verified date: February 2021
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Pancreatoduodenectomy

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Surgery, University Hospital Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of arrosion bleeding		>24 hours after partial pancreatoduodenectomy