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Superior Bilioenteric Anastomosis by Magnetic Compressive Technique (CTREG)

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ClinicalTrials.gov Identifier: NCT02801500
Recruitment Status : Recruiting
First Posted : June 16, 2016
Last Update Posted : September 21, 2017
Sponsor:
Collaborators:
Shaanxi Provincial People's Hospital
Tang-Du Hospital
First Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital of Xinjiang Medical University
General Hospital of Ningxia Medical University
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 superior bilioenteric anastomosis.

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

Detailed Description:

The superior 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, thus they are lack of convictive evidence of evidence-based medicine for the security, reliability and convince.

This study is a multicenter, prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive superior bilioenteric anastomosis, this study compared the incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need superior bilioenteric anastomosis operation. The study design plan to enroll 70 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Superior Bilioenteric Anastomosis by Magnetic Compressive Technique: A Multicenter, Prospective, Randomized Controlled Trial
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis.
Device: Magnetic Compressive Anastomosis
The magnetic compressive anastomosis device 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 ]

Secondary Outcome Measures :
  1. Length of bilioenteric anastomosis time [ Time Frame: during operation ]
  2. Number of patients who have discharged the device on the date expected. [ Time Frame: 1 to 4 weeks postoperation ]
  3. Number of patients who have been diagnosed as discharge disorder of magnetic device [ Time Frame: less than 1 week or more than 4 weeks ]
  4. average length of postoperative hospital stay [ Time Frame: 3 months ]
  5. Times of pathological examination of bile duct's remnant of Klatskin' tumor [ Time Frame: during operation ]
  6. Bilioenteric anastomotic stricture [ Time Frame: Time Frame: 1,3,6,12-month post operation ]


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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 superior 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): NCT02801500


Contacts
Contact: Yi Lv, MD,PHD 0086-13991200581 luyi169@126.com

Locations
China, Shaanxi
First Affiliated Hospital of Xian JiaotongUniversity Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Yi Lv, MD,PHD    0086-13991200581    luyi169@126.com   
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Xiaopeng Yan, PHD    08615332432878    yanxiaopeng99@163.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Shaanxi Provincial People's Hospital
Tang-Du Hospital
First Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital of Xinjiang Medical University
General Hospital of Ningxia Medical University

Publications of Results:

Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02801500     History of Changes
Other Study ID Numbers: XJTU1AF-CRF-2015-001
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Cholangiocarcinoma
Calculi
Klatskin Tumor
Gallstones
Cholelithiasis
Cholecystolithiasis
Choledochal Cyst
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Cysts
Bile Duct Diseases
Digestive System Abnormalities
Congenital Abnormalities