Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of 3D Typing on Surgical Treatment of 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: NCT03098251
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
Information provided by (Responsible Party):
feng xiaobin, Southwest Hospital, China

Brief Summary:
According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis.

Condition or disease Intervention/treatment Phase
Hepatolithiasis Surgery Procedure: 3D typing Procedure: routine typing Not Applicable

Detailed Description:
According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis. In this cohort study, two group will be enrolled to compare the outcomes.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of 3D Typing and Routine Typing on Surgical Treatment of Hepatolithiasis
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: 3D typing
typing the patient with 3D typing system and give treatment according preestablished algorism in our center.
Procedure: 3D typing
typing the patient with 3D typing system and give specific treatment

Active Comparator: routine typing
typing the patient with routine typing system and give treatment according preestablished algorism in our center.
Procedure: routine typing
typing the patient with routine typing system and give specific treatment




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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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): NCT03098251


Contacts
Layout table for location contacts
Contact: Xiaobin Feng, MD +86-2368765297 fengxiaobin200708@aliyun.com

Locations
Layout table for location information
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
Layout table for additonal information
Responsible Party: feng xiaobin, clinical professor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT03098251    
Other Study ID Numbers: SWHB017
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No