Trans-parenchymal Compressing Suture in Major Liver Resection
Primary Purpose
Liver Carcinoma Resectable
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TCS
Sponsored by
About this trial
This is an interventional prevention trial for Liver Carcinoma Resectable
Eligibility Criteria
Inclusion Criteria:
- tumor size more than 5cm
- non-anatomical liver resection;
Exclusion Criteria:
- intravascular infiltration with tumor embolus;
- previous liver surgical treatment (e.g. microwave ablation; preoperative transcatheter arterial chemoembolization (TACE);
- other concomitant extrahepatic procedures (e.g. splenectomy).
- exposed Glisson Shealth, main hepatic veins or (and) retro-hepatic inferior vena cava.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Trans-parenchymal compressing suture
Exposed surface (ES)
Arm Description
TCS: After liver transection, check for active hemorrhage and visible sites of bile leakage of cutting surface by stainless gauze which covered up on the raw cutting surface for 5 minutes. For patients with any positive findings including bloodstain and (or) bile staining, the cutting surface was recognized as "not good" cutting surface and further trans-parenchymal compressing sutured, if possible, using a hepatic needle.
147 Patients with exposed surface (ES) were matched as control group. No TCS.
Outcomes
Primary Outcome Measures
Cutting surface related complications
After liver resection, some complication related cutting surface may occur, including surgery site infection, bile leakage, bleeding.
Secondary Outcome Measures
Interventions for cutting surface related complications
Once the cutting surface related complications occur, some interventions need to be performed to treat these complications, such as percutaneous abdominal paracentesis or reoperation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03215290
Brief Title
Trans-parenchymal Compressing Suture in Major Liver Resection
Official Title
Application of Trans-parenchymal Compressing Suture in Major Liver Resection to Decrease Cutting Surface Related Complication.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Non-anatomical liver resection with appropriate resection margin was regarded as a potential curative treatment for selected major hepatic carcinoma due to preserving maximal normal liver, especially in cirrhotic patients. But occurrence of cutting surface related complications become a main challenge.
Detailed Description
In order to better manage the cutting surface after liver resection, we further applied trans-parenchymal compressing suture to "not good" cutting surface in hope of decreasing cutting surface related complication. A majority of studies investigating cutting surface management are limited to non-surgical treatments, such as the application of hemostasis agents including fibrin sealants, oxidized cellulose, and absorbable gelatin sponge13-15 . But there is no consensus regarding the necessity of the hemostatic agent application to the liver cutting surface. Up to date, few studies investigate surgical suture management of the cutting surface in liver resection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Carcinoma Resectable
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
382 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trans-parenchymal compressing suture
Arm Type
Experimental
Arm Description
TCS: After liver transection, check for active hemorrhage and visible sites of bile leakage of cutting surface by stainless gauze which covered up on the raw cutting surface for 5 minutes. For patients with any positive findings including bloodstain and (or) bile staining, the cutting surface was recognized as "not good" cutting surface and further trans-parenchymal compressing sutured, if possible, using a hepatic needle.
Arm Title
Exposed surface (ES)
Arm Type
No Intervention
Arm Description
147 Patients with exposed surface (ES) were matched as control group. No TCS.
Intervention Type
Procedure
Intervention Name(s)
TCS
Other Intervention Name(s)
trans-parenchymal compressing suture
Intervention Description
The cutting surface recognized as "not good" cutting surface was further trans-parenchymal compressing sutured, if possible, using a hepatic needle.
Primary Outcome Measure Information:
Title
Cutting surface related complications
Description
After liver resection, some complication related cutting surface may occur, including surgery site infection, bile leakage, bleeding.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Interventions for cutting surface related complications
Description
Once the cutting surface related complications occur, some interventions need to be performed to treat these complications, such as percutaneous abdominal paracentesis or reoperation.
Time Frame
90 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
tumor size more than 5cm
non-anatomical liver resection;
Exclusion Criteria:
intravascular infiltration with tumor embolus;
previous liver surgical treatment (e.g. microwave ablation; preoperative transcatheter arterial chemoembolization (TACE);
other concomitant extrahepatic procedures (e.g. splenectomy).
exposed Glisson Shealth, main hepatic veins or (and) retro-hepatic inferior vena cava.
12. IPD Sharing Statement
Learn more about this trial
Trans-parenchymal Compressing Suture in Major Liver Resection
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