Superior Bilioenteric Anastomosis by Magnetic Compressive Technique

Hilar Cholangiocarcinoma Clinical Trial

— CTREG  

Official title:

Superior Bilioenteric Anastomosis by Magnetic Compressive Technique: A Multicenter, Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02801500
• Other study ID #: XJTU1AF-CRF-2015-001
• Status: Recruiting
• Phase: N/A
• First received: May 29, 2016
• Last updated: September 19, 2017
• Start date: July 1, 2017
• Est. completion date: June 2019

Study information

• Verified date: September 2017
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yi Lv, MD,PHD
• Phone: 0086-13991200581
• Email: luyi169[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bile Duct Injury
• Biliary Calculi
• Calculi
• Cholangiocarcinoma
• Cholecystolithiasis
• Choledochal Cyst
• Cholelithiasis
• Gallstones
• Hilar Cholangiocarcinoma
• Klatskin Tumor

Intervention

Device:
• Magnetic Compressive Anastomosis
The magnetic compressive anastomosis device will be used to complete the anastomosis during bilioenteric anastomosis.

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian JiaotongUniversity	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (6)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital, Sun Yat-Sen University, General Hospital of Ningxia Medical University, Shaanxi Provincial People's Hospital, Tang-Du Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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 — View 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. — View 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. — View Citation

Outcome

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