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New treatment option for Pancreatectomy
Official title Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty
ClinicalTrials.gov ID: NCT05992857
What this study is testing
- What it's testing
- To assess the efficacy of complete covering using retromesenteric omentoplasty vs. partial covering or no covering of peripancreatic arteries in decreasing incidence of grade B+C post-pancreatectomy hemorrhage (PPH), i.e.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Patients requiring a pancreaticoduodenectomy (PD) for any indication
- Open approach
- Affiliation to the French public healthcare insurance
- Fistula risk score (FRS) ≥ 7 confirmed intraoperatively
You likely can't join if
- Presence of distant tumor deposits (liver and peritoneal metastases, and/or para-aortic lymph nodes metastases) reveals during intraoperative...
- Patients with previous abdominal surgery compromising completion of retromesenteric omentoplasty
- PD with arterial resection (i.e. resection of hepatic artery, splenic artery, superior mesenteric artery, or celiac axis)
- Laparoscopic or robotic PD
- Reconstruction wih pancreatico-gastrostomy
- Total pancreatectomy
See the full eligibility criteria
- Age ≥ 18 years
- Patients requiring a pancreaticoduodenectomy (PD) for any indication
- Open approach
- Affiliation to the French public healthcare insurance
- Fistula risk score (FRS) ≥ 7 confirmed intraoperatively
- Ability to understand and to comply with the study protocol
- Reconstruction with PJ and external pancreatic stent
- Signed written informed consent
- Inclusion is allowed for patients:
- On curative or long-term anticoagulation or aspirin (indicated for previous thromboembolic complications, heart disease, previous history of stroke)
- Undergoing PD with venous resection
- Presence of distant tumor deposits (liver and peritoneal metastases, and/or para-aortic lymph nodes metastases) reveals during intraoperative exploration for patient with malignant pancreatic or periampullary tumor.
- Patients with previous abdominal surgery compromising completion of retromesenteric omentoplasty
- PD with arterial resection (i.e. resection of hepatic artery, splenic artery, superior mesenteric artery, or celiac axis)
- Laparoscopic or robotic PD
- Reconstruction wih pancreatico-gastrostomy
- Total pancreatectomy
- Emergency procedure
- Pregnant women
- Patient under guardianship and curatorship
- Participation in another treatment study evaluating complication after pancreaticoduodenectomy or patient still being in the exclusion period at the end of a previous study evaluating drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Clichy, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clichy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.