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Trans-parenchymal Compressing Suture in Major Liver Resection

T

Tongji Hospital

Status

Completed

Conditions

Liver Carcinoma Resectable

Treatments

Procedure: TCS

Study type

Interventional

Funder types

Other

Identifiers

NCT03215290
TJ-201206

Details and patient eligibility

About

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.

Full 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.

Enrollment

382 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. tumor size more than 5cm
  2. non-anatomical liver resection;

Exclusion criteria

  1. intravascular infiltration with tumor embolus;
  2. previous liver surgical treatment (e.g. microwave ablation; preoperative transcatheter arterial chemoembolization (TACE);
  3. other concomitant extrahepatic procedures (e.g. splenectomy).
  4. exposed Glisson Shealth, main hepatic veins or (and) retro-hepatic inferior vena cava.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

382 participants in 2 patient groups

Trans-parenchymal compressing suture
Experimental group
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.
Treatment:
Procedure: TCS
Exposed surface (ES)
No Intervention group
Description:
147 Patients with exposed surface (ES) were matched as control group. No TCS.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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