Safety and Efficacy of Simultaneous or Staged Surgery on Complicated Hepatolithiasis

Hepatolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03098264
• Other study ID #: SWHB018
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: April 11, 2017
• Start date: April 11, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2017
• Source: Southwest Hospital, China
• Contact: Xiaobin Feng, MD
• Phone: +86-2368765297
• Email: fengxiaobin200708[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 31, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatolithiasis

Intervention

Procedure:
• Simultaneous surgery
Simultaneous surgery in complicated hepatolithiasis
• staged surgery
staged surgery in complicated hepatolithiasis

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (9)

Lead Sponsor	Collaborator
Southwest Hospital, China	Chinese PLA General Hospital, Eastern Hepatobiliary Surgery Hospital, First Affiliated Hospital of Zhongshan Medical University, Fourth Military Medical University, Huaxi Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Tongji Hospital, Union hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	residual ratio of biliary stone	residual ratio of biliary stone diagnosed within 3 months	3 months
Secondary	postoperative complications	postoperative complications diagnosed within 6 months	6 months
Secondary	residual lesions	residual lesions diagnosed within 6 months	6 months
Secondary	Health economics index	Health economics index within 3 months	3 months
Secondary	mortality	mortality occured within 3 months	3 months