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

NCT ID: NCT02121886

Last Updated: 2014-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-12-31

Brief 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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parietal peritoneum

Group Type: EXPERIMENTAL

venous reconstruction with the parietal peritoneum

Intervention Type: PROCEDURE

Interventions

venous reconstruction with the parietal peritoneum

Intervention Type: PROCEDURE

Other Intervention Names

Liver resection; Pancreatic resection; Venous resection; Reconstruction; Parietal peritoneum

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beaujon Hospital

OTHER

Sponsor Role: lead

Responsible Party

Safi Dokmak

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Departement HPB surgery, Beaujon Hospital

Clichy, Hauts de seine, France

Site Status: RECRUITING

Countries

France

Central Contacts

Safi Dokmak, MD

Role: CONTACT

safi.dokmak@bjn.aphp.fr

0033140875797

Facility Contacts

Safi Dokmak, MD

Role: primary

safi.dokmak@bjn.aphp.fr

0033140875797

References

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.

Reference Type: DERIVED

PMID: 25243564 (View on PubMed)

Other Identifiers

Departement of HPB surgery

Identifier Type: OTHER

Identifier Source: secondary_id

Departement of HPB surgery

Identifier Type: -

Identifier Source: org_study_id