NCT03098264

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

April 11, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

1.7 years

First QC Date

March 20, 2017

Last Update Submit

April 11, 2017

Conditions

Hepatolithiasis

Outcome Measures

Primary Outcomes (1)

  • residual ratio of biliary stone

    residual ratio of biliary stone diagnosed within 3 months

    3 months

Secondary Outcomes (4)

  • postoperative complications

    6 months

  • residual lesions

    6 months

  • Health economics index

    3 months

  • mortality

    3 months

Study Arms (2)

Simultaneous surgery

EXPERIMENTAL

to perform surgery both on biliary stone and portal hypertension

Procedure: Simultaneous surgery

Staged surgery

ACTIVE COMPARATOR

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

Procedure: staged surgery

Interventions

Simultaneous surgeryPROCEDURE

Simultaneous surgery in complicated hepatolithiasis

Simultaneous surgery
staged surgeryPROCEDURE

staged surgery in complicated hepatolithiasis

Staged surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Interventions

Overlapping Surgery

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Xiaobin Feng, MD

CONTACT

+86-2368765297fengxiaobin200708@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 31, 2017

Study Start

April 11, 2017

Primary Completion

December 30, 2018

Study Completion

December 31, 2018

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

CN(1)