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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02588066
Enrollment
400
Registered
2015-10-27
Start date
2015-11-30
Completion date
2020-07-31
Last updated
2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatoduodenectomy

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.

Interventions

PROCEDURELigamentum teres/falciform-plasty

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

Sponsors

Technische Universität Dresden
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of arrosion bleeding>24 hours after partial pancreatoduodenectomy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026