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Bilioenteric Anastomosis by Magnetic Compressive Technique (BAMCT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774589
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : November 18, 2019
Sponsor:
Collaborators:
Health Science Center of Xi'an Jiaotong University
Northwest Institute for Non-ferrous Metal Research
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:
The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on bilioenteric anastomosis.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Cholangiocarcinoma Bile Duct Injury Choledochal Cyst Biliary Calculi Procedure: Magnetic Compressive Anastomosis Procedure: Manual Anastomosis Not Applicable

Detailed Description:
The bilioenteric anastomosis is one of the most common and difficult operations in Hepatobiliary Surgery. The traditional manual anastomosis has become one of the main prognosis factors because of the length of suture time, the difficulty of operation, the high incidence of anastomotic leakage and stricture. Magnetic compressive anastomosis can realize the fast anastomosis, reduce the difficulty, and reduce the incidence of anastomotic leakage and stricture. Currently, the majority of studies of magnetic compressive bilioenteric anastomosis are merely confined within clinical case report and single-center, small sample, retrospective study. This study is a prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive bilioenteric anastomosis versus traditional suture method on incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need bilioenteric anastomosis operation. The study is to enroll about 200 patients and divide into Study Group (Group A: Magnetic compressive anastomosis) and Control Group (Group B: traditional manual anastomosis) as 1:1 ratio randomly by stratification factors. The incidence of anastomotic leakage and stricture, length of bilioenteric anastomosis time, value of serum bilirubin, length of discharge time of magnetic device and mean time of hospital stay will be evaluated. The patients will drop out of the study if adverse events happen, active request for dropping out, new-onset severe disease or death. The primary and secondary end point will be observed by regular follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bilioenteric Anastomosis by Magnetic Compressive Technique: A Prospective, Randomized Controlled Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2022


Arm Intervention/treatment
Experimental: Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis.
Procedure: Magnetic Compressive Anastomosis
The magnetic compressive anastomosis will be used to complete the anastomosis during bilioenteric anastomosis.

Active Comparator: Traditional Manual Anastomosis
A handsewn technique will be used during bilioenteric anastomosis.
Procedure: Manual Anastomosis
A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.




Primary Outcome Measures :
  1. Bilioenteric anastomotic leakage [ Time Frame: 1 month post operation ]
    To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis


Secondary Outcome Measures :
  1. Length of bilioenteric anastomosis time [ Time Frame: during operation ]
    To compare the anastomotic time between magnetic and hand-sewn groups

  2. Time from the date of operation to expel of the magnets. [ Time Frame: 1 to 4 weeks postoperation ]
    To confirm the safe discharge of the magnets

  3. average length of postoperative hospital stay [ Time Frame: 3 months ]
    To compare the length of stay between magnetic and hand-sewn groups

  4. Bilioenteric anastomotic stricture [ Time Frame: 1,3,6,12-month post operation ]
    To compare the long-term outcome between magnetic and hand-sewn groups



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with age between 18 to 75
  • Patients' gender was not limited
  • Patients who were well-diagnosed and had the indication for bilioenteric anastomosis.
  • Patients whose lifetimes will be longer than 12 months.
  • Patients who are willing to join this clinical trial and informed consent form voluntarily.

Exclusion Criteria:

  • Woman during pregnancy or lactation or anyone with mental disorder
  • The wall of hepatic duct or jejunum was too thick so that the attractive force of magnetic device cannot meet the requirements of compression.
  • Any anatomical variation in bile ducts system or the inner diameter is too small so that the magnetic device cannot place in.
  • Any foreign body has been implanted in body, such as heart pacemaker.
  • Surgical contraindication, including:

Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long- term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.

• Any other disease in perioperation periods which needs MRI examination in the next 8 weeks post operation.


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): NCT03774589


Contacts
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Contact: Yi Lv, MD,PHD 86-29-85323900 luyi169@126.com
Contact: Xu-Feng Zhang, MD, PhD 86-29-85323626 xfzhang125@126.com

Locations
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China, Shaanxi
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Yi Lv, MD,PHD    0086-13991200581    luyi169@126.com   
Contact: Rongfeng Wang, MD    0086-15877553630    15877553630@163.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Health Science Center of Xi'an Jiaotong University
Northwest Institute for Non-ferrous Metal Research
Investigators
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Principal Investigator: Yi Lv, MD,PHD China, Shaanxi First Affiliated Hospital of Xian JiaotongUniversity
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03774589    
Other Study ID Numbers: XJTU1AF-CRF-2015-001-1
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
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
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
bilioenteric anastomosis
magnetic compressive technique
morbidity
Additional relevant MeSH terms:
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Cholangiocarcinoma
Choledochal Cyst
Gallstones
Calculi
Neoplasms
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathological Conditions, Anatomical
Cysts
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Abnormalities
Congenital Abnormalities
Cholelithiasis
Cholecystolithiasis
Gallbladder Diseases