The Efficacy of a Topical Anti-adhesive Film for Decreasing Perihepatic Adhesions in Repeat Hepatic Surgery

April 27, 2021 updated by: Dr. Chad G. Ball, University of Calgary
There has been an increase in the need for repeat hepatic surgery, especially for patients with colorectal liver metastasis and hepatocellular carcinoma. Adhesions at the time of repeat surgery can lead to increased operative times, higher blood loss and even increased perioperative morbidity. Not much data exists regarding use of anti-adhesion barriers at the time of index hepatectomy and their effect on adhesions at repeat hepatectomy. This randomized controlled trial aims to evaluate the effectiveness of the use of a hyaluronan and cellulose based antiadhesive topical film at index hepatectomy in reducing perihepatic adhesions at the time of repeat hepatic surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Peritoneal adhesions develop in up to 93% of patients following abdominal surgery.1 Mesothelial injury, inflammation and unbalanced fibrinolysis have been described as the primary factors leading to adhesion formation.2 Within hepatic surgery, the degree to which adhesions pose a significant challenge at the time of repeat resection often depends upon the extent of hepatectomy, hilar dissection, number of preceding liver resections, and the location of the proposed repeat partial hepatectomy. More specifically, peri-hepatic adhesions can lead to increased operative time, an increased risk of bleeding, injury to adjacent intra-abdominal organs and even higher perioperative morbidity.3 Similar to other diseases, repeat hepatectomy is often required in instances of both primary and metastatic liver cancers. This need will likely only increase in the future with continuously improving systemic chemotherapy and novel multimodality treatments. Not surprisingly, the necessary lysis of peri-hepatic adhesions has also been shown to increase operative times, by consuming as much as 50% of the operative procedure, during a repeat hepatectomy as well.4

Numerous anti-adhesion materials and barriers have been studied in colorectal,5,6,7 gynecological,8,9 neurosurgery,10 cardiac surgery,11 and otolaryngology.12 There is some data that these barriers can also be helpful in reducing operative times for repeat hepatectomy as well.13 More specifically, in a rat model, an Alg bilayer sponge application was effective in preventing peri-hepatic adhesions following a crush hepatectomy model.14 Unfortunately, there has been limited data regarding the effectiveness of any antiadhesion barriers in reducing peri-hepatic adhesions to date. SEPRA-C2T15 concluded that barrier film is helpful in reducing abdominal and perihepatic adhesions. This was done in patients with unresectable colorectal liver metastasis who underwent two stage hepatectomy and the median time to second hepatectomy was only 2 months.

The primary aim of this study is to evaluate the efficacy of a topical anti-adhesion barrier film in reducing the severity of subsequent peri-hepatic adhesions at the time of repeat hepatic surgery.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients undergoing partial hepatectomy with high likelihood of needing repeat hepatectomy (e.g. those with colorectal liver metastasis and hepatocellular carcinoma)
  2. Patients ≥ 18 years of age.

Exclusion Criteria:

  1. Patients unable to provide informed consent.
  2. Patients with hypersensitivity to Seprafilm and/or to any components of the Seprafilm.
  3. Patients who are found to have unresectable disease during surgery (additional hepatic lesions or extrahepatic metastatic disease precluding liver resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Seprafilm
Antiadhesion barrier applied
Other: Adhesion barrier
Adhesion barrier application at the time of first surgery
No Intervention: No seprafilm
No barrier applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of peri-hepatic adhesions at the time of repeat liver surgery
Time Frame: 0-4 years from initial surgery, time of repeat surgery will vary from patient to patient

Evaluation will be performed at second surgery as follows:

Calgary Scoring System Grade1-No adhesions, Grade2-Mild, Grade3-Moderate, Grade4-Severe adhesions, Grade5-severe adhesions with injury to other organs

TORanomon Adhesion score (TORAD score):

  • Hepatic Hilum

    • 1-Easy: Easy for encircling the hepatoduodenal ligament (HDL)
    • 2-Hard: Additional maneuver for encircling HDL
    • 3-Extreme: Safe encircling of HDL is impossible

  • Liver Surface

    • 1-Easy: No adhesion
    • 2-Hard: Presence of dense fibrosis or scarring tissue- hard dissection
    • 3-Extreme): Dense scar with unclear boundary with the surrounding organs.
0-4 years from initial surgery, time of repeat surgery will vary from patient to patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating time
Time Frame: 0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient
Operating time will be measured in minutes. Hypothesis is that increased adhesions will increase the operating time.
0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient
Estimated blood loss
Time Frame: 0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient
Estimated blood loss will be measured in milliliters. Increased adhesions lead to increase estimated blood loss.
0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient
Transfusion of blood or blood products
Time Frame: 0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient
Will be measured in # of units, increased adhesions lead to increased blood loss and therefore increased need for blood/blood product transfusion
0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient
Duration of hepatic pedicle clamping
Time Frame: 0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient
Will be measured in minutes. Increased adhesions and blood loss may prompt clamping of hepatic pedicle to decrease blood flow to the liver to decrease active blood loss.
0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient
Postoperative length of stay
Time Frame: 0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient
Will be measured in days, increased adhesions may mean longer surgery and longer recovery time which will increase length of stay in the hospital for the patients
0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient
30-day mortality and morbidity
Time Frame: 30 days after the repeat surgery which may be anywhere from 0-4 months after initial surgery
30-day postoperative morbidity will be classified according to the Clavien-Dindo classification (I-V). I being any deviation from normal postoperative course to V being death of patient. Postoperative morbidity will include liver failure (defined according to the International Study Group of Liver Surgery criteria), ascites, intra-abdominal fluid collection, bile leak, hemorrhage, pleural effusion, pulmonary embolism and deep venous thrombosis. Medical complications including acute myocardial infarction, cerebrovascular accident/transient ischemic attack, acute kidney injury will also be recorded. Infectious complications will include pneumonia, urinary tract infection, bloodstream infection, and surgical site infection.
30 days after the repeat surgery which may be anywhere from 0-4 months after initial surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (Actual)

November 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIVER-SEPRAFILM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to submit the study protocol for a journal publication

IPD Sharing Time Frame

Within the next 6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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