Liver Neoplasms Clinical Trial
Official title:
The Efficacy of a Topical Anti-adhesive Film for Decreasing Perihepatic Adhesions in Repeat Hepatic Surgery
Verified date | April 2021 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | June 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Operating time | 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 | |
Secondary | Estimated blood loss | 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 | |
Secondary | Transfusion of blood or blood products | 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 | |
Secondary | Duration of hepatic pedicle clamping | 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 | |
Secondary | Postoperative length of stay | 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 | |
Secondary | 30-day mortality and morbidity | 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 |
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