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

NCT02121886 | Unknown

• 1 other identifier: Departement of HPB surgery
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Safety; Availability; Venous Patency; Oncological Benefits; Morbidity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Long-term venous Patency

  Up to 6 months

Other Outcomes (1)

• Oncological benefit and rate or R0 venous resection

  up to 1 month

Study Arms (1)

Parietal peritoneum

EXPERIMENTAL

Procedure: venous reconstruction with the parietal peritoneum

Interventions

venous reconstruction with the parietal peritoneum PROCEDURE

Also known as: Liver resection, Pancreatic resection, Venous resection, Reconstruction, Parietal peritoneum

Parietal peritoneum

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beaujon Hospital: lead

Study Sites (1)

Departement HPB surgery, Beaujon Hospital

Clichy, Hauts de seine, 92110, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 25243564 DERIVED

MeSH Terms

Interventions

Hepatectomy; Plastic Surgery Procedures

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Safi Dokmak, MD

CONTACT

0033140875797; safi.dokmak@bjn.aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 20, 2014
• First Posted: April 24, 2014
• Study Start: December 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

FR (1)