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Safety and Efficacy of Simultaneous or Staged Surgery on Complicated Hepatolithiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098264
Recruitment Status : Unknown
Verified April 2017 by feng xiaobin, Southwest Hospital, China.
Recruitment status was:  Recruiting
First Posted : March 31, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborators:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Chinese PLA General Hospital
Eastern Hepatobiliary Surgery Hospital
First Affiliated Hospital of Zhongshan Medical University
Fourth Military Medical University
Huaxi Hospital
Tongji Hospital
Union hospital of Fujian Medical University
Information provided by (Responsible Party):
feng xiaobin, 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.

Condition or disease Intervention/treatment Phase
Hepatolithiasis Procedure: Simultaneous surgery Procedure: staged surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cohort Study on Safety and Efficacy of Simultaneous or Staged Surgery in Complicated Hepatolithiasis
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Arm Intervention/treatment
Experimental: Simultaneous surgery
to perform surgery both on biliary stone and portal hypertension
Procedure: Simultaneous surgery
Simultaneous surgery in complicated hepatolithiasis

Active Comparator: Staged surgery
to perform surgery on biliary stone and portal hypertension by staged surgery
Procedure: staged surgery
staged surgery in complicated hepatolithiasis




Primary Outcome Measures :
  1. residual ratio of biliary stone [ Time Frame: 3 months ]
    residual ratio of biliary stone diagnosed within 3 months


Secondary Outcome Measures :
  1. postoperative complications [ Time Frame: 6 months ]
    postoperative complications diagnosed within 6 months

  2. residual lesions [ Time Frame: 6 months ]
    residual lesions diagnosed within 6 months

  3. Health economics index [ Time Frame: 3 months ]
    Health economics index within 3 months

  4. mortality [ Time Frame: 3 months ]
    mortality occured within 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098264


Contacts
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Contact: Xiaobin Feng, MD +86-2368765297 fengxiaobin200708@aliyun.com

Locations
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China, Chongqing
Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: xiaobin Feng, MD         
Sponsors and Collaborators
Southwest Hospital, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Chinese PLA General Hospital
Eastern Hepatobiliary Surgery Hospital
First Affiliated Hospital of Zhongshan Medical University
Fourth Military Medical University
Huaxi Hospital
Tongji Hospital
Union hospital of Fujian Medical University
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Responsible Party: feng xiaobin, Doctor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT03098264    
Other Study ID Numbers: SWHB018
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No