Superior Bilioenteric Anastomosis by Magnetic Compressive Technique
NCT ID: NCT02801500
Last Updated: 2017-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2017-07-01
2019-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis.
Magnetic Compressive Anastomosis
The magnetic compressive anastomosis device will be used to complete the anastomosis during bilioenteric anastomosis.
Traditional Manual Anastomosis
A handsewn technique will be used during bilioenteric anastomosis.
Manual Anastomosis
A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.
Interventions
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Magnetic Compressive Anastomosis
The magnetic compressive anastomosis device will be used to complete the anastomosis during bilioenteric anastomosis.
Manual Anastomosis
A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Shaanxi Provincial People's Hospital
OTHER
Tang-Du Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
General Hospital of Ningxia Medical University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Locations
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First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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XJTU1AF-CRF-2015-001
Identifier Type: -
Identifier Source: org_study_id