The Parietal Peritoneum as a Substitute Graft for Venous Reconstruction in HPB Surgery

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

Study Overview

• Status: Unknown
• Conditions: Safety; Morbidity; Availability; Venous Patency; Oncological Benefits
• Intervention / Treatment: Procedure: venous reconstruction with the parietal peritoneum

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Safi Dokmak, MD; Phone Number: 0033140875797; Email: safi.dokmak@bjn.aphp.fr

Study Locations

• France
  • Hauts de seine
    • Clichy, Hauts de seine, France, 92110
      • Recruiting
      • Departement HPB surgery, Beaujon Hospital
      • Contact: Safi Dokmak, MD; Phone Number: 0033140875797; Email: safi.dokmak@bjn.aphp.fr
      • Principal Investigator: Safi Dokmak, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients who refuse to participate and patients with suspected peritoneal carcinomatosis or if intra-operative exploration confirmed the presence of peritoneal carcinomatosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parietal peritoneum	Procedure: venous reconstruction with the parietal peritoneum; Other Names: Liver resection; Reconstruction; Pancreatic resection; Venous resection; Parietal peritoneum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oncological benefit and rate or R0 venous resection	We will study on histology the rate of R0 resection (margins tumor free) in order to see if this technique allow us to resect largely the tumor with the benefit to increase the rate of R0 resection on the vein and surrounding structures	up to 1 month

Collaborators and Investigators

• Sponsor: Beaujon Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: April 20, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 24, 2014

Study Record Updates

• Last Update Posted (Estimate): April 24, 2014
• Last Update Submitted That Met QC Criteria: April 23, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: Departement of HPB surgery (Other Identifier: Beaujon Hospital, Clichy, France)