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

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ClinicalTrials.gov Identifier: NCT04641923
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Chad G. Ball, University of Calgary

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adhesion Liver Neoplasms Other: Adhesion barrier Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study population will consist of all consecutive adult patients undergoing a partial hepatectomy with a high likelihood of repeat hepatectomy. These will include patients with colorectal liver metastasis and those with hepatocellular carcinoma. All patients who consent to undergo a partial hepatectomy at the Foothills Medical Center and who meet the inclusion criteria will be contacted via phone prior to their surgery by a trial research assistant in order to obtain informed consent for enrolment in the trial. Patients will be randomized with a 1:1 ratio for seprafilm vs no seprafilm group.
Masking: Single (Participant)
Masking Description: Once eligibility has been determined, participants will be randomized with a 1:1 ratio using a block randomization model. The randomization tool will be located on a password-protected website. In order to maintain allocation concealment, the assigned intervention (i.e. Seprafilm use) will be provided to the surgeon in an opaque, sealed envelope immediately before surgery by the research assistant. Patients and data analysts will be blinded to treatment allocation status.
Primary Purpose: Prevention
Official Title: The Efficacy of a Topical Anti-adhesive Film for Decreasing Perihepatic Adhesions in Repeat Hepatic Surgery
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04641923


Locations
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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
More Information
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Publications of Results:

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Responsible Party: Dr. Chad G. Ball, Professor of Surgery and Oncology, University of Calgary
ClinicalTrials.gov Identifier: NCT04641923    
Other Study ID Numbers: LIVER-SEPRAFILM
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to submit the study protocol for a journal publication
Supporting Materials: Study Protocol
Time Frame: Within the next 6 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Neoplasms
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases