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

NCT04641923 | Unknown

• 1 other identifier: LIVER-SEPRAFILM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesion; Liver Neoplasms

Outcome Measures

Primary Outcomes (1)

• Incidence of peri-hepatic adhesions at the time of repeat liver surgery

  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 Outcomes (6)

• Operating time

  0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient

• 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

  0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient

• Duration of hepatic pedicle clamping

  0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient

• Postoperative length of stay

  0-4 years from initial surgery, unpredictable - time of repeat surgery will vary from patient to patient

Study Arms (2)

Seprafilm

EXPERIMENTAL

Antiadhesion barrier applied

Other: Adhesion barrier

No seprafilm

NO INTERVENTION

No barrier applied

Interventions

Adhesion barrier OTHER

Adhesion barrier application at the time of first surgery

Seprafilm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (15)

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  PMID: 4580750 RESULT

• Schnuriger B, Barmparas G, Branco BC, Lustenberger T, Inaba K, Demetriades D. Prevention of postoperative peritoneal adhesions: a review of the literature. Am J Surg. 2011 Jan;201(1):111-21. doi: 10.1016/j.amjsurg.2010.02.008.

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• Arung W, Meurisse M, Detry O. Pathophysiology and prevention of postoperative peritoneal adhesions. World J Gastroenterol. 2011 Nov 7;17(41):4545-53. doi: 10.3748/wjg.v17.i41.4545.

  PMID: 22147959 RESULT

• Kobayashi Y, Shindoh J, Igata Y, Okubo S, Hashimoto M. A novel scoring system for evaluating the difficulty of lysis of adhesion and surgical risk at repeat hepatectomy. J Hepatobiliary Pancreat Sci. 2020 Apr;27(4):191-199. doi: 10.1002/jhbp.708. Epub 2020 Feb 14.

  PMID: 31944589 RESULT

• Ahmad G, O'Flynn H, Hindocha A, Watson A. Barrier agents for adhesion prevention after gynaecological surgery. Cochrane Database Syst Rev. 2015 Apr 30;2015(4):CD000475. doi: 10.1002/14651858.CD000475.pub3.

  PMID: 25924805 RESULT

• Shimizu A, Hasegawa K, Masuda K, Omichi K, Miyata A, Kokudo N. Efficacy of Hyaluronic Acid/Carboxymethyl Cellulose-Based Bioresorbable Membranes in Reducing Perihepatic Adhesion Formation: A Prospective Cohort Study. Dig Surg. 2018;35(2):95-103. doi: 10.1159/000472883. Epub 2017 May 12.

  PMID: 28494442 RESULT

• Kumar S, Wong PF, Leaper DJ. Intra-peritoneal prophylactic agents for preventing adhesions and adhesive intestinal obstruction after non-gynaecological abdominal surgery. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD005080. doi: 10.1002/14651858.CD005080.pub2.

  PMID: 19160246 RESULT

• Fazio VW, Cohen Z, Fleshman JW, van Goor H, Bauer JJ, Wolff BG, Corman M, Beart RW Jr, Wexner SD, Becker JM, Monson JR, Kaufman HS, Beck DE, Bailey HR, Ludwig KA, Stamos MJ, Darzi A, Bleday R, Dorazio R, Madoff RD, Smith LE, Gearhart S, Lillemoe K, Gohl J. Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection. Dis Colon Rectum. 2006 Jan;49(1):1-11. doi: 10.1007/s10350-005-0268-5.

  PMID: 16320005 RESULT

• Becker JM, Dayton MT, Fazio VW, Beck DE, Stryker SJ, Wexner SD, Wolff BG, Roberts PL, Smith LE, Sweeney SA, Moore M. Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. J Am Coll Surg. 1996 Oct;183(4):297-306.

  PMID: 8843257 RESULT

• Ten Broek RPG, Stommel MWJ, Strik C, van Laarhoven CJHM, Keus F, van Goor H. Benefits and harms of adhesion barriers for abdominal surgery: a systematic review and meta-analysis. Lancet. 2014 Jan 4;383(9911):48-59. doi: 10.1016/S0140-6736(13)61687-6. Epub 2013 Sep 27.

  PMID: 24075279 RESULT

• Mumert ML, Altay T, Couldwell WT. Technique for decompressive craniectomy using Seprafilm as a dural substitute and anti-adhesion barrier. J Clin Neurosci. 2012 Mar;19(3):455-7. doi: 10.1016/j.jocn.2011.09.004. Epub 2012 Jan 14.

  PMID: 22245275 RESULT

• Kaneko Y, Hirata Y, Achiwa I, Morishita H, Soto H, Kobayahsi J. Adhesion barrier reduces postoperative adhesions after cardiac surgery. Asian Cardiovasc Thorac Ann. 2012 Jun;20(3):257-62. doi: 10.1177/0218492311435154.

  PMID: 22718712 RESULT

• Caylan R, Bektas D. Preservation of the mastoid aeration and prevention of mastoid dimpling in chronic otitis media with cholesteatoma surgery using hyaluronate-based bioresorbable membrane (Seprafilm). Eur Arch Otorhinolaryngol. 2007 Apr;264(4):377-80. doi: 10.1007/s00405-006-0193-9. Epub 2006 Nov 9.

  PMID: 17093997 RESULT

• Ohta S, Toda T, Inagaki F, Omichi K, Shimizu A, Kokudo N, Hasegawa K, Ito T. The Prevention of Hepatectomy-Induced Adhesions by Bilayer Sponge Composed of Ultrapure Alginate. J Surg Res. 2019 Oct;242:286-295. doi: 10.1016/j.jss.2019.04.063. Epub 2019 May 21.

  PMID: 31125842 RESULT

• Dupre A, Lefranc A, Buc E, Delpero JR, Quenet F, Passot G, Evrard S, Rivoire M. Use of bioresorbable membranes to reduce abdominal and perihepatic adhesions in 2-stage hepatectomy of liver metastases from colorectal cancer: results of a prospective, randomized controlled phase II trial. Ann Surg. 2013 Jul;258(1):30-6. doi: 10.1097/SLA.0b013e3182854949.

  PMID: 23426344 RESULT

MeSH Terms

Conditions

Tissue Adhesions; Liver Neoplasms

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery and Oncology

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 24, 2020
• Study Start: November 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within the next 6 months

Locations

CA (1)