Safety and Efficacy of Simultaneous or Staged Surgery on Complicated Hepatolithiasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-11

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatolithiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simultaneous surgery

to perform surgery both on biliary stone and portal hypertension

Group Type EXPERIMENTAL

Simultaneous surgery

Intervention Type PROCEDURE

Simultaneous surgery in complicated hepatolithiasis

Staged surgery

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

Group Type ACTIVE_COMPARATOR

staged surgery

Intervention Type PROCEDURE

staged surgery in complicated hepatolithiasis

Interventions

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Simultaneous surgery

Simultaneous surgery in complicated hepatolithiasis

Intervention Type PROCEDURE

staged surgery

staged surgery in complicated hepatolithiasis

Intervention Type PROCEDURE

Eligibility Criteria

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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.