Safety and Efficacy of Simultaneous or Staged Surgery on Complicated Hepatolithiasis

A Cohort Study on Safety and Efficacy of Simultaneous or Staged Surgery in Complicated Hepatolithiasis

For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed.

Study Overview

• Status: Unknown
• Conditions: Hepatolithiasis
• Intervention / Treatment: Procedure: Simultaneous surgery; Procedure: staged surgery

Detailed Description

For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed. In this protocol, we will assign the eligible cases into two group. And then perform surgery as simultaneously or separately.By long-term follow-up,to examine the safety and advantages of each procedure.

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Recruiting
      • Southwest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged from 18 to 65 years old
• Without gender restriction
• With a favorable liver function of Child-Pugh A to B
• No contraindications to surgery and anesthesia
• Diagnosed with Hepatolithiasis and portal hypertension
• Signed informed consent.

Exclusion Criteria:

• Diffused type of Hepatolithiasis
• Impairment in liver function
• Severe disorders in vital organ
• Accompanied with tumors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Simultaneous surgery; to perform surgery both on biliary stone and portal hypertension	Procedure: Simultaneous surgery; Simultaneous surgery in complicated hepatolithiasis
ACTIVE_COMPARATOR: Staged surgery; to perform surgery on biliary stone and portal hypertension by staged surgery	Procedure: staged surgery; staged surgery in complicated hepatolithiasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
residual ratio of biliary stone	residual ratio of biliary stone diagnosed within 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	postoperative complications diagnosed within 6 months	6 months
residual lesions	residual lesions diagnosed within 6 months	6 months
Health economics index	Health economics index within 3 months	3 months
mortality	mortality occured within 3 months	3 months

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Collaborators: Chinese PLA General Hospital; Tongji Hospital; Second Affiliated Hospital, School of Medicine, Zhejiang University; Eastern Hepatobiliary Surgery Hospital; Air Force Military Medical University, China; Huaxi Hospital; Union hospital of Fujian Medical University; First Affiliated Hospital of Zhongshan Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2017
• Primary Completion (ANTICIPATED): December 30, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (ACTUAL): March 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: SWHB018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No