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
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Condition or disease | Intervention/treatment | Phase |
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Hilar Cholangiocarcinoma Bile Duct Injury Choledochal Cyst Biliary Calculi | Device: Magnetic Compressive Anastomosis Procedure: Manual Anastomosis | Not Applicable |
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 |
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Experimental: Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis.
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Device: Magnetic Compressive Anastomosis
The magnetic compressive anastomosis device will be used to complete the anastomosis during bilioenteric anastomosis.
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Active Comparator: Traditional Manual Anastomosis
A handsewn technique will be used during bilioenteric anastomosis.
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Procedure: Manual Anastomosis
A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.
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- Bilioenteric anastomotic leakage [ Time Frame: 1 month post operation ]
- Length of bilioenteric anastomosis time [ Time Frame: during operation ]
- Number of patients who have discharged the device on the date expected. [ Time Frame: 1 to 4 weeks postoperation ]
- Number of patients who have been diagnosed as discharge disorder of magnetic device [ Time Frame: less than 1 week or more than 4 weeks ]
- average length of postoperative hospital stay [ Time Frame: 3 months ]
- Times of pathological examination of bile duct's remnant of Klatskin' tumor [ Time Frame: during operation ]
- 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, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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