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

Not Applicable

Not yet recruiting

• Conditions: Adhesion; Liver Neoplasms
• Interventions: Other: Adhesion barrier

• Registration Number: NCT04641923
• Lead Sponsor: University of Calgary

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.

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 Timeline

• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-24
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28
• Study Start: 2022-11
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seprafilm	Adhesion barrier	Antiadhesion barrier applied

Primary Outcome Measures

Name	Time	Method
Incidence of peri-hepatic adhesions at the time of repeat liver surgery	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

Name	Time	Method
Operating time	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.
Transfusion of blood or blood products	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
Duration of hepatic pedicle clamping	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.
Estimated blood loss	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.
Postoperative length of stay	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
30-day mortality and morbidity	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.

Trial Locations

Locations (1)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada