SafetyNCT02121886
The Parietal Peritoneum as a Substitute Graft for Venous Reconstruction in HPB Surgery
A study testing venous reconstruction with the parietal peritoneum in people with Safety and Availability, run by Beaujon Hospital at 1 site in France.
Trial summary
To evaluate the safety and outcome of the parietal peritoneum for venous reconstruction HPB surgery. Although the parietal peritoneum had already been used and published for the reconstruction of the vena cava, however this one was never described or described in HPB surgery Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Availability, Venous Patency
- What is being tested?
- venous reconstruction with the parietal peritoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients admitted to HPB unit and schudeled for major liver or pancreatic resections with suspected venous invasion. Venous invasion is suspected on CT scan (vein narrowing or disappearance of the fat plane between the vein and the tumor) performed within 1 month of surgical resection. Informed consent will be obtained and the parietal peritoneum will be used as a substitute graft for resection-reconstruction in these patients if intra-operative exploration confirmed this venous invasion
Who cannot join
- Patients who refuse to participate and patients with suspected peritoneal carcinomatosis or if intra-operative exploration confirmed the presence of peritoneal carcinomatosis
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Departement HPB surgery, Beaujon Hospital
Clichy, Hauts de seine, 92110
Safi Dokmak, MD, 0033140875797, safi.dokmak@bjn.aphp.fr
Safi Dokmak, MD
About this study
Official title: To Evaluate the Safety and Outcome of the Parietal Peritoneum as a Substitute Graft for Venous Reconstruction in Hepatobiliary and Pancreatic Surgery
To evaluate the safety and outcome of the parietal peritoneum for venous reconstruction HPB surgery. Although the parietal peritoneum had already been used and published for the reconstruction of the vena cava, however this one was never described or described in HPB surgery
Read the detailed description
Improvements in surgical techniques, perioperative management and effective chemotherapy regimens, have increased the resectability of malignant hepatobiliary and pancreatic tumors when associated with vascular invasion. Therefore, simultaneous vascular resection is increasingly required to obtain an adequate resection margin and improve patient definite survival. Although most vascular resection associated with pancreatectomy can be reconstructed by simple venorraphy or end-to-end anastomosis, a segmental or lateral vacular graft (VG) can be necessary in 8-12 % of cases. Vascular reconstruction can be planned preoperatively if the vascular invasion is evident and an appropriate VG can be prepared. Differents sources of VG are available including autogenous veins , synthetic such as polytetrafluoroethylene (PTFE) , cryopreserved and veins from the resected liver. However the decision to perform vascular resection may be made during dissection due to vascular invasion or injury and even occasionnally taken while the mesentericoportal vein (MPV) or vena cava (VC) are occluded. In this emergency situation, an urgent and easily available graft is necessary to prevent prolonged ischemia. The difficulty of anticipating the need for these vascular resections during HPB surgery, has lead certain authors including those in our group to use either the veins from the resected liver, the umbilical vein or the parietal peritoneum (PP) for vena cava reconstruction. The aim of our study is to evaluate the safety and outcome of the parietal peritoneum as a substitute patch for venous reconstruction during HPB surgery in emergency and elective situations.
- Conditions
- Safety, Availability, Venous Patency, Oncological Benefits, Morbidity
- Being tested
- venous reconstruction with the parietal peritoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous reconstruction with the parietal peritoneumProcedure or surgery
Also called Liver resection, Pancreatic resection, Venous resection, Reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Parietal peritoneum | Experimental | Not described Receives: Procedure: venous reconstruction with the parietal peritoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and venous patency
The primary outcome of this study will be the safety and venous patency. Safety means "to see if the parietal peritoneum is rigid and there is no tearing of bleeding in the reconstructed area, related to venous pressure", this safety will be assessed clinically (exteriorized bleeding from the reconstructed zone and on CT scan to search for local hematoma). Patency will be assessed by regular CT scan performed on postoperative day 8,30,90 and 120. On CT scan, this evaluation will include the degree on venous stenosis (0%, <25%, 25%-75%, >75%, thrombosis) compared to non reconstructed vein, the presence of thrombosis with collateral venous circulation or venous enlargement in the reconstructed area
Measured: Up to 4 months
Secondary outcomes (1)
Long-term venous Patency
The venous latency will be assessed at 6 months of the surgical resection and the assessment with be done by CT scan in order to study the degree of venous stenosis, the presence or not of thrombosis or collateral venous circulation and venous enlargement.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startDec 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SafetyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beaujon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safi Dokmak, Beaujon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121886
- Sponsor's protocol ID
- Departement of HPB surgery
- Other IDs
- Departement of HPB surgery
- Status last verified
- Apr 2014
- First submitted
- 20 Apr 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dokmak S, Aussilhou B, Sauvanet A, Nagarajan G, Farges O, Belghiti J. Parietal Peritoneum as an Autologous Substitute for Venous Reconstruction in Hepatopancreatobiliary Surgery. Ann Surg. 2015 Aug;262(2):366-71. doi: 10.1097/SLA.0000000000000959.
PubMed 25243564
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and Outcome of the Parietal Peritoneum as a Substitute Graft for Venous Reconstruction in Hepatobiliary and Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT02121886
- Acronym / sponsor ID
- Departement of HPB surgery
- Conditions
- Safety, Availability, Venous Patency, Oncological Benefits, Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beaujon HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 24 Apr 2014 (estimated)
- 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 evaluate the safety and outcome of the parietal peritoneum for venous reconstruction HPB surgery. Although the parietal peritoneum had already been used and published for the reconstruction of the vena cava, however this one was never described or described in HPB surgery
Detailed description
Improvements in surgical techniques, perioperative management and effective chemotherapy regimens, have increased the resectability of malignant hepatobiliary and pancreatic tumors when associated with vascular invasion. Therefore, simultaneous vascular resection is increasingly required to obtain an adequate resection margin and improve patient definite survival. Although most vascular resection associated with pancreatectomy can be reconstructed by simple venorraphy or end-to-end anastomosis, a segmental or lateral vacular graft (VG) can be necessary in 8-12 % of cases. Vascular reconstruction can be planned preoperatively if the vascular invasion is evident and an appropriate VG can be prepared. Differents sources of VG are available including autogenous veins , synthetic such as polytetrafluoroethylene (PTFE) , cryopreserved and veins from the resected liver. However the decision to perform vascular resection may be made during dissection due to vascular invasion or injury and even occasionnally taken while the mesentericoportal vein (MPV) or vena cava (VC) are occluded. In this emergency situation, an urgent and easily available graft is necessary to prevent prolonged ischemia. The difficulty of anticipating the need for these vascular resections during HPB surgery, has lead certain authors including those in our group to use either the veins from the resected liver, the umbilical vein or the parietal peritoneum (PP) for vena cava reconstruction. The aim of our study is to evaluate the safety and outcome of the parietal peritoneum as a substitute patch for venous reconstruction during HPB surgery in emergency and elective situations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parietal peritoneum | Experimental | Procedure: venous reconstruction with the parietal peritoneum |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to HPB unit and schudeled for major liver or pancreatic resections with suspected venous invasion. Venous invasion is suspected on CT scan (vein narrowing or disappearance of the fat plane between the vein and the tumor) performed within 1 month of surgical resection. Informed consent will be obtained and the parietal peritoneum will be used as a substitute graft for resection-reconstruction in these patients if intra-operative exploration confirmed this venous invasion
Key exclusion criteria (1 listed)
- Patients who refuse to participate and patients with suspected peritoneal carcinomatosis or if intra-operative exploration confirmed the presence of peritoneal carcinomatosis
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 |
|---|---|---|
| venous reconstruction with the parietal peritoneumAlso: Liver resection, Pancreatic resection, Venous resection, Reconstruction | Procedure or surgery | Parietal peritoneum |
Primary outcome
Safety and venous patency
Time frame: Up to 4 months
The primary outcome of this study will be the safety and venous patency. Safety means "to see if the parietal peritoneum is rigid and there is no tearing of bleeding in the reconstructed area, related to venous pressure", this safety will be assessed clinically (exteriorized bleeding from the reconstructed zone and on CT scan to search for local hematoma). Patency will be assessed by regular CT scan performed on postoperative day 8,30,90 and 120. On CT scan, this evaluation will include the degree on venous stenosis (0%, <25%, 25%-75%, >75%, thrombosis) compared to non reconstructed vein, the presence of thrombosis with collateral venous circulation or venous enlargement in the reconstructed area
1 secondary outcome
Long-term venous Patency
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Derived from this study: PubMed 25243564Dokmak S, Aussilhou B, Sauvanet A, Nagarajan G, Farges O, Belghiti J. Parietal Peritoneum as an Autologous Substitute for Venous Reconstruction in Hepatopancreatobiliary Surgery. Ann Surg. 2015 Aug;262(2):366-71. doi: 10.1097/SLA.0000000000000959.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing venous reconstruction with the parietal peritoneum in people with Safety and Availability, run by Beaujon Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Apr 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Safi Dokmak, MD (0033140875797, safi.dokmak@bjn.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and venous patency (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121886, which also lists 1 linked publication.
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 24 Apr 2014.