PancreatectomyPACOMARCONCT05992857
Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty
A study testing Pancreaticoduodenectomy without retromesenteric omental flap and Pancreaticoduodenectomy with retromesenteric omental flap in people with Pancreatectomy and Complication of Surgical Procedure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatectomy, Complication of Surgical Procedure
- What is being tested?
- Pancreaticoduodenectomy without retromesenteric omental flap and Pancreaticoduodenectomy with retromesenteric omental flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Reconstruction with PJ and external pancreatic stent
- Signed written informed consent
- On curative or long-term anticoagulation or aspirin (indicated for previous thromboembolic complications, heart disease, previous history of stroke)
- Undergoing PD with venous resection
Who cannot join
- 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
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- Emergency procedure
- Pregnant women
- Patient under guardianship and curatorship
- Participation in another interventional study evaluating complication after pancreaticoduodenectomy or patient still being in the exclusion period at the end of a previous study evaluating drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Safi DOKMAK, MD. PhD contact
France1 site, 1 recruiting
- Recruiting
Beaujon Hospital
Clichy, 92118
Alain SAUVANET, MD, PHD, alain.sauvanet@aphp.fr
About this study
Official title: Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.
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. treated by transfusion and / or radiological or surgical hemostasis after PD in patients with high risk of POPF.
Read the detailed description
Grade B+C postpancreatectomy hemorrhage (PPH) is a severe complication following pancreaticoduodenectomy (PD), more frequently observed in patients with high-risk of postoperative pancreatic fistula (POPF). To date no randomized controlled trial has assessed the impact of an omentoplasty covering all arteries exposed during PD on the prevention of clinically relevant postpancreatectomy hemorrhage (PPH) in patients with high-risk of POPF (fistula risk score between 7 to 10)
In the standard technique, no omental flap is used or an omental flap is only interposed between the pancreatic anastomosis and the hepatic artery, and/or the round ligament wraps the hepatic artery only. An orignal approach is proposed using a J-shaped omental flap created by the mobilization of the greater omentum and ascended through the retromesentric route to cover all the peri-pancreatic arteries at risk of bleeding after pancreatic resection.
Patient fulfilling eligibility criteria will be enrolled during a selection visit (V0) which may take place 45 days and up to 1 day prior PD surgery. Patient will be randomized intra-operatively either in the experimental arm or the control arm for allocation the omental covering technique.
After surgery, the following visits will be planned for the patient follow up:
- V2: End of hospitalization visit which can be done up to 1 day prior discharge.
- V3: POD 45 (±15) days which will take place at the hospital.
- Vai: Additional visit which may take place if the patient is readmitted for postoperative complication. Those visits may take place between V2 and V4 up to 1 day prior discharge.
- V4: POD 90 (±15) days is the end of study visit. It will take place at the hospital.
During those visits, data will be collected to validate the primary and secondary endpoints of the trial.
- Conditions
- Pancreatectomy, Complication of Surgical Procedure
- Being tested
- Pancreaticoduodenectomy without retromesenteric omental flap, Pancreaticoduodenectomy with retromesenteric omental flap
- Keywords
- Pancreaticoduodenectomy, Post-pancreatectomy haemorrhage, Omentoplasty, Post-operative pancreatic fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaticoduodenectomy without retromesenteric omental flapProcedure or surgery
Resection of the pancreatic head, duodenum, distal common bile duct and gallbladder followed by reconstruction using pancreaticojejunostomy, hepaticojejunostomy, and gastrojejunostomy performed on the first jejunal loop.
Pancreaticoduodenectomy with retromesenteric omental flapProcedure or surgery
All exposed peripancratic arteries should be covered with a retromesentric omental flap
| Study group | Role | What they receive |
|---|---|---|
| Retromesenteric omental flap covering all exposed peripancreatic arteries | Experimental | A J-shaped omental flap is created by extensive mobilization of the greater omentum, and if needed, lengthening by division of vertical collaterals of gastroepiploic vessels section or thinning it out in patients with visceral obesity. This omental flap is ascended through the retromesentric route to cover all the peri-pancreatic vessels at risk of bleeding after pancreatic resection (hepatic artery, proximal part of the splenic artery, superior mesenteric artery, and right hepatic artery originating from superior mesenteric artery when present) Receives: Procedure: Pancreaticoduodenectomy with retromesenteric omental flap |
| Control | Active comparator | No omental flap or an omental flap not using the retromesenteric route and only interposed between the pancreatic anastomosis and the hepatic artery, or a single round ligament flap wrapping the hepatic artery only. Receives: Procedure: Pancreaticoduodenectomy without retromesenteric omental flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postpancreatectomy haemorrhage clinically significant (graded B or C)
According to the definition of the International Study Group of Pancreatic Surgery (ISGPS)
- Grade B: PPH is early (< 24h) or late bleeding without any organ failure
- Grade C: PPH is late bleeding with organ failure (hemodynamic, renal, cardiac, respiratory failure)
- Both grade B and C bleeding require transfusion and/or a procedure to obtain hemostasis including radiological embolization, endoscopic intervention or reoperation.
Measured: From surgery to post-operative day 90
Secondary outcomes (7)
Mortality
Measured: From surgery to post-operative day 90
Overall Morbidity
Assessed by comprehensive complication index (CCI)
Measured: From surgery to post-operative day 90
Rate of grade B+C post-operative pancreatic fistula
According to 2016 ISGPF classification (Bassi C et al. 2016) :
-Amylase level in the drainage fluid (or fluid of any collection) exceeding 3 times the upper limit of local laboratory norm of serum amylase level co-existing with clinically significant deviation from the normal post operative course.
Measured: From post-operative day 3 to post-operative day 90
Rate of grade A post-pancreatectomy haemorrhage
[12:51] Alain (Invité)
Post pancreatectomy haemorrhage requiring neither transfusion nor hemostatic procedure
Measured: From surgery to post-operative day 90
Hospital readmission
Defined by unplanned readmission
Measured: From end of initial hospital stay to post-operative day 90
Total duration of hospital stay
Including duration of initial stay and readmision if present
Measured: From surgery to post-operative day 90
Rate of arterial pseudoaneurysm
Detected by routine enhanced CT with intravenous contrast injection
Measured: Performed at post-operative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start22 Oct 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National, Phase IIIb multicenter, centrally randomized open-label trial with two parallel arms. Participants will be distributed between the two arms at a ratio (1:1). Randomization will be built by block of unequal size stratified by center and the prophylactic use of somatostatin/octreotide-Yes/No
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain SAUVANET, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992857
- Sponsor's protocol ID
- APHP220823
- Acronym
- PACOMARCO
- Status last verified
- Nov 2025
- First submitted
- 8 Aug 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.
- ClinicalTrials.gov ID
- NCT05992857
- Acronym / sponsor ID
- PACOMARCO / APHP220823
- Conditions
- Pancreatectomy, Complication of Surgical Procedure
- Keywords
- Pancreaticoduodenectomy, Post-pancreatectomy haemorrhage, Omentoplasty, Post-operative pancreatic fistula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. treated by transfusion and / or radiological or surgical hemostasis after PD in patients with high risk of POPF.
Detailed description
Grade B+C postpancreatectomy hemorrhage (PPH) is a severe complication following pancreaticoduodenectomy (PD), more frequently observed in patients with high-risk of postoperative pancreatic fistula (POPF). To date no randomized controlled trial has assessed the impact of an omentoplasty covering all arteries exposed during PD on the prevention of clinically relevant postpancreatectomy hemorrhage (PPH) in patients with high-risk of POPF (fistula risk score between 7 to 10)
In the standard technique, no omental flap is used or an omental flap is only interposed between the pancreatic anastomosis and the hepatic artery, and/or the round ligament wraps the hepatic artery only. An orignal approach is proposed using a J-shaped omental flap created by the mobilization of the greater omentum and ascended through the retromesentric route to cover all the peri-pancreatic arteries at risk of bleeding after pancreatic resection.
Patient fulfilling eligibility criteria will be enrolled during a selection visit (V0) which may take place 45 days and up to 1 day prior PD surgery. Patient will be randomized intra-operatively either in the experimental arm or the control arm for allocation the omental covering technique.
After surgery, the following visits will be planned for the patient follow up:
- V2: End of hospitalization visit which can be done up to 1 day prior discharge.
- V3: POD 45 (±15) days which will take place at the hospital.
- Vai: Additional visit which may take place if the patient is readmitted for postoperative complication. Those visits may take place between V2 and V4 up to 1 day prior discharge.
- V4: POD 90 (±15) days is the end of study visit. It will take place at the hospital.
During those visits, data will be collected to validate the primary and secondary endpoints of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- National, Phase IIIb multicenter, centrally randomized open-label trial with two parallel arms. Participants will be distributed between the two arms at a ratio (1:1). Randomization will be built by block of unequal size stratified by center and the prophylactic use of somatostatin/octreotide-Yes/No
| Arm | Type | Receives |
|---|---|---|
| Retromesenteric omental flap covering all exposed peripancreatic arteries | Experimental | Procedure: Pancreaticoduodenectomy with retromesenteric omental flapA J-shaped omental flap is created by extensive mobilization of the greater omentum, and if needed, lengthening by division of vertical collaterals of gastroepiploic vessels section or thinning it out in patients with visceral obesity. This omental flap is ascended through the retromesentric route to cover all the peri-pancreatic vessels at risk of bleeding after pancreatic resection (hepatic artery, proximal part of the splenic artery, superior mesenteric artery, and right hepatic artery originating from superior mesenteric artery when present) |
| Control | Active comparator | Procedure: Pancreaticoduodenectomy without retromesenteric omental flapNo omental flap or an omental flap not using the retromesenteric route and only interposed between the pancreatic anastomosis and the hepatic artery, or a single round ligament flap wrapping the hepatic artery only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreaticoduodenectomy without retromesenteric omental flapResection of the pancreatic head, duodenum, distal common bile duct and gallbladder followed by reconstruction using pancreaticojejunostomy, hepaticojejunostomy, and gastrojejunostomy performed on the first jejunal loop. | Procedure or surgery | Control |
| Pancreaticoduodenectomy with retromesenteric omental flapAll exposed peripancratic arteries should be covered with a retromesentric omental flap | Procedure or surgery | Retromesenteric omental flap covering all exposed peripancreatic arteries |
Primary outcome
Rate of postpancreatectomy haemorrhage clinically significant (graded B or C)
Time frame: From surgery to post-operative day 90
According to the definition of the International Study Group of Pancreatic Surgery (ISGPS) * Grade B: PPH is early (< 24h) or late bleeding without any organ failure * Grade C: PPH is late bleeding with organ failure (hemodynamic, renal, cardiac, respiratory failure) * Both grade B and C bleeding require transfusion and/or a procedure to obtain hemostasis including radiological embolization, endoscopic intervention or reoperation.
7 secondary outcomes
Mortality
Time frame: From surgery to post-operative day 90
Overall Morbidity
Time frame: From surgery to post-operative day 90
Rate of grade B+C post-operative pancreatic fistula
Time frame: From post-operative day 3 to post-operative day 90
Rate of grade A post-pancreatectomy haemorrhage
Time frame: From surgery to post-operative day 90
Hospital readmission
Time frame: From end of initial hospital stay to post-operative day 90
Total duration of hospital stay
Time frame: From surgery to post-operative day 90
Rate of arterial pseudoaneurysm
Time frame: Performed at post-operative day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Safi DOKMAK, MD. PhD contact
Alain SAUVANET, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreaticoduodenectomy without retromesenteric omental flap and Pancreaticoduodenectomy with retromesenteric omental flap in people with Pancreatectomy and Complication of Surgical Procedure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain SAUVANET, MD, PhD (+33140875948 ext. 33, alain.sauvanet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postpancreatectomy haemorrhage clinically significant (graded B or C) (time frame: From surgery to post-operative day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.