Safety and Efficacy of Simultaneous or Staged Surgery on Complicated Hepatolithiasis

Not Applicable

• Conditions: Hepatolithiasis
• Interventions: Procedure: Simultaneous surgery; Procedure: staged surgery

• Registration Number: NCT03098264
• Lead Sponsor: Southwest Hospital, China

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-31
• Status Verified: 2017-04
• Study Start: 2017-04-11
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-12
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simultaneous surgery	Simultaneous surgery	to perform surgery both on biliary stone and portal hypertension
Staged surgery	staged surgery	to perform surgery on biliary stone and portal hypertension by staged surgery

Primary Outcome Measures

Name	Time	Method
residual ratio of biliary stone	3 months	residual ratio of biliary stone diagnosed within 3 months

Secondary Outcome Measures

Name	Time	Method
residual lesions	6 months	residual lesions diagnosed within 6 months
mortality	3 months	mortality occured within 3 months
postoperative complications	6 months	postoperative complications diagnosed within 6 months
Health economics index	3 months	Health economics index within 3 months

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China