NCT03215290

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

June 29, 2017

Last Update Submit

July 10, 2017

Conditions

Liver Carcinoma Resectable

Outcome Measures

Primary Outcomes (1)

  • Cutting surface related complications

    After liver resection, some complication related cutting surface may occur, including surgery site infection, bile leakage, bleeding.

    90 days

Secondary Outcomes (1)

  • Interventions for cutting surface related complications

    90 days

Study Arms (2)

Trans-parenchymal compressing suture

EXPERIMENTAL

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.

Procedure: TCS

Exposed surface (ES)

NO INTERVENTION

147 Patients with exposed surface (ES) were matched as control group. No TCS.

Interventions

TCSPROCEDURE

The cutting surface recognized as "not good" cutting surface was further trans-parenchymal compressing sutured, if possible, using a hepatic needle.

Also known as: trans-parenchymal compressing suture
Trans-parenchymal compressing suture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • tumor size more than 5cm
  • non-anatomical liver resection;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 12, 2017

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

July 12, 2017

Record last verified: 2017-07