Safety and Efficacy of Simultaneous or Staged Surgery on Complicated Hepatolithiasis

Army Medical University

Status: Unknown

Conditions: Hepatolithiasis

Treatments: Procedure: staged surgery; Procedure: Simultaneous surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03098264

SWHB018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Simultaneous surgery

Experimental group

Description:

to perform surgery both on biliary stone and portal hypertension

Treatment:

Procedure: Simultaneous surgery

Staged surgery

Active Comparator group

Description:

to perform surgery on biliary stone and portal hypertension by staged surgery

Treatment:

Procedure: staged surgery