ERAS Program Improves Recovery of HCC Patient Undergoing Hepatectomy

NCT03104920 | Unknown DMC

• 1 other identifier: SWHB016
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief Summary

The worldwide introduction of multimodal enhanced recovery programs has also changed perioperative care in patients who undergo liver resection. This study will be performed to assess a comprehensive care package for patients with hepatocellular carcinoma (HCC) undergoing hepatectomy with the aim of minimal physiological disturbance in the peri-operative period. Peri-operative opioid-sparing analgesia with few gastrointestinal (GI) effects and reduced requirement for intravenous fluid therapy, early ambulation and promoted GI function recovery were centered to this plan.

Conditions

HCC

Keywords

ERAS; Time to ready for discharge

Outcome Measures

Primary Outcomes (1)

• TRD (time to ready for discharge)

  time to ready for discharge

  1 month after surgery

Secondary Outcomes (9)

• Readmission within 30 days of discharge

  30 days after surgery

• Complications rate

  3 months after surgery

• Postoperative LOS (length of hospital stay)

  30 days after surgery

• Liver function recovery

  30 days after surgery

• Surgery Stress （CRP）

  15 days after surgery

Study Arms (2)

ERAS program

EXPERIMENTAL

We give an ERAS pathway, which comprises of optimized management of diet, mobilization, analgesia and GI function recovery for patients with HCC.

Procedure: ERAS Program

Traditional treatment

ACTIVE COMPARATOR

We give routine clinic practices for the treatment of HCC.

Procedure: Traditional treatment

Interventions

ERAS Program PROCEDURE

An ERAS pathway comprises of optimized management of diet, mobilization, multimodal perioperative analgesia and GI function recovery modalities.

ERAS program

Traditional treatment PROCEDURE

A traditional perioperative management for HCC.

Traditional treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent;
• Elective partial hepatectomy for HCC;
• No major concomitant surgical procedures such as bowl or bile duct resection;
• Tumors restricted in hepatic segment: II, III, IVb, VI and VII;
• Child-Pugh Class A/B liver function status；
• ECGO scores = 0

You may not qualify if:

• Tumor thrombi in portal vein;
• Tumor size \>10cm;
• History of uncontrolled ascites, hepatic encephalopathy, and varices bleeding;
• ICG\>14%;
• Concurrent with other malignant disease;
• Multiple organ dysfunctions;
• Viral infectious disease besides HBV and HCV;
• Diabetes Mellitus;
• Ruptured hepatocellular carcinoma;
• History of treatment such as TACE, RFI, PEI.

Sponsors & Collaborators

• feng xiaobin: lead

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Study Officials

• Kuansheng Ma, Doctor

  Third Military Medical University

  STUDY DIRECTOR

Central Study Contacts

Xiaobin Feng, Doctor

CONTACT

86-23-68765297; fengxiaobin200708@aliyun.com

Lei Tang, Doctor

CONTACT

86-13709091333; tleimc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Proffesor

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 7, 2017
• Study Start: March 27, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 7, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)