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Superior Bilioenteric Anastomosis by Magnetic Compressive Technique (CTREG)

Primary Purpose

Hilar Cholangiocarcinoma, Bile Duct Injury, Choledochal Cyst

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magnetic Compressive Anastomosis
Manual Anastomosis
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hilar Cholangiocarcinoma focused on measuring bilioenteric anastomosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital of Xian JiaotongUniversityRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Magnetic Compressive Anastomosis

Traditional Manual Anastomosis

Arm Description

A magnetic device will be used during bilioenteric anastomosis.

A handsewn technique will be used during bilioenteric anastomosis.

Outcomes

Primary Outcome Measures

Bilioenteric anastomotic leakage

Secondary Outcome Measures

Length of bilioenteric anastomosis time
Number of patients who have discharged the device on the date expected.
Number of patients who have been diagnosed as discharge disorder of magnetic device
average length of postoperative hospital stay
Times of pathological examination of bile duct's remnant of Klatskin' tumor
Bilioenteric anastomotic stricture

Full Information

First Posted
May 29, 2016
Last Updated
September 19, 2017
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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
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1. Study Identification

Unique Protocol Identification Number
NCT02801500
Brief Title
Superior Bilioenteric Anastomosis by Magnetic Compressive Technique
Acronym
CTREG
Official Title
Superior Bilioenteric Anastomosis by Magnetic Compressive Technique: A Multicenter, Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hilar Cholangiocarcinoma, Bile Duct Injury, Choledochal Cyst, Biliary Calculi
Keywords
bilioenteric anastomosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnetic Compressive Anastomosis
Arm Type
Experimental
Arm Description
A magnetic device will be used during bilioenteric anastomosis.
Arm Title
Traditional Manual Anastomosis
Arm Type
Active Comparator
Arm Description
A handsewn technique will be used during bilioenteric anastomosis.
Intervention Type
Device
Intervention Name(s)
Magnetic Compressive Anastomosis
Intervention Description
The magnetic compressive anastomosis device will be used to complete the anastomosis during bilioenteric anastomosis.
Intervention Type
Procedure
Intervention Name(s)
Manual Anastomosis
Intervention Description
A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.
Primary Outcome Measure Information:
Title
Bilioenteric anastomotic leakage
Time Frame
1 month post operation
Secondary Outcome Measure Information:
Title
Length of bilioenteric anastomosis time
Time Frame
during operation
Title
Number of patients who have discharged the device on the date expected.
Time Frame
1 to 4 weeks postoperation
Title
Number of patients who have been diagnosed as discharge disorder of magnetic device
Time Frame
less than 1 week or more than 4 weeks
Title
average length of postoperative hospital stay
Time Frame
3 months
Title
Times of pathological examination of bile duct's remnant of Klatskin' tumor
Time Frame
during operation
Title
Bilioenteric anastomotic stricture
Time Frame
Time Frame: 1,3,6,12-month post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Lv, MD,PHD
Phone
0086-13991200581
Email
luyi169@126.com
Facility Information:
Facility Name
First Affiliated Hospital of Xian JiaotongUniversity
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Lv, MD,PHD
Phone
0086-13991200581
Email
luyi169@126.com
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaopeng Yan, PHD
Phone
08615332432878
Email
yanxiaopeng99@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15849514
Citation
Sicklick JK, Camp MS, Lillemoe KD, Melton GB, Yeo CJ, Campbell KA, Talamini MA, Pitt HA, Coleman J, Sauter PA, Cameron JL. Surgical management of bile duct injuries sustained during laparoscopic cholecystectomy: perioperative results in 200 patients. Ann Surg. 2005 May;241(5):786-92; discussion 793-5. doi: 10.1097/01.sla.0000161029.27410.71.
Results Reference
result
PubMed Identifier
16632990
Citation
House MG, Cameron JL, Schulick RD, Campbell KA, Sauter PK, Coleman J, Lillemoe KD, Yeo CJ. Incidence and outcome of biliary strictures after pancreaticoduodenectomy. Ann Surg. 2006 May;243(5):571-6; discussion 576-8. doi: 10.1097/01.sla.0000216285.07069.fc.
Results Reference
result
PubMed Identifier
8912621
Citation
Frattaroli FM, Reggio D, Guadalaxara A, Illomei G, Pappalardo G. Benign biliary strictures: a review of 21 years of experience. J Am Coll Surg. 1996 Nov;183(5):506-13.
Results Reference
result
PubMed Identifier
18161934
Citation
Yan JQ, Peng CH, Ding JZ, Yang WP, Zhou GW, Chen YJ, Tao ZY, Li HW. Surgical management in biliary restricture after Roux-en-Y hepaticojejunostomy for bile duct injury. World J Gastroenterol. 2007 Dec 28;13(48):6598-602. doi: 10.3748/wjg.v13.i48.6598.
Results Reference
result
PubMed Identifier
19393505
Citation
Avaliani M, Chigogidze N, Nechipai A, Dolgushin B. Magnetic compression biliary-enteric anastomosis for palliation of obstructive jaundice: initial clinical results. J Vasc Interv Radiol. 2009 May;20(5):614-23. doi: 10.1016/j.jvir.2009.01.019.
Results Reference
result
PubMed Identifier
15824939
Citation
Chopita N, Vaillaverde A, Cope C, Bernedo A, Martinez H, Landoni N, Jmelnitzky A, Burgos H. Endoscopic gastroenteric anastomosis using magnets. Endoscopy. 2005 Apr;37(4):313-7. doi: 10.1055/s-2005-861358.
Results Reference
result
PubMed Identifier
1294807
Citation
Stepanov EA, Vasil'ev GS, Nikolaev VV. [The treatment of intestinal fistulae in children by applying a by-pass anastomosis using magnetic devices]. Khirurgiia (Mosk). 1992 Nov-Dec;(11-12):93-5. Russian.
Results Reference
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PubMed Identifier
22207929
Citation
Fan C, Ma J, Zhang HK, Gao R, Li JH, Yu L, Wu Z, Lv Y. Sutureless intestinal anastomosis with a novel device of magnetic compression anastomosis. Chin Med Sci J. 2011 Sep;26(3):182-9. doi: 10.1016/s1001-9294(11)60046-1.
Results Reference
result

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Superior Bilioenteric Anastomosis by Magnetic Compressive Technique

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