NCT02801500

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

May 29, 2016

Last Update Submit

September 19, 2017

Conditions

Hilar CholangiocarcinomaBile Duct InjuryCholedochal CystBiliary Calculi

Keywords

bilioenteric anastomosis

Outcome Measures

Primary Outcomes (1)

  • Bilioenteric anastomotic leakage

    1 month post operation

Secondary Outcomes (6)

  • Length of bilioenteric anastomosis time

    during operation

  • Number of patients who have discharged the device on the date expected.

    1 to 4 weeks postoperation

  • Number of patients who have been diagnosed as discharge disorder of magnetic device

    less than 1 week or more than 4 weeks

  • average length of postoperative hospital stay

    3 months

  • Times of pathological examination of bile duct's remnant of Klatskin' tumor

    during operation

  • +1 more secondary outcomes

Study Arms (2)

Magnetic Compressive Anastomosis

EXPERIMENTAL

A magnetic device will be used during bilioenteric anastomosis.

Device: Magnetic Compressive Anastomosis

Traditional Manual Anastomosis

ACTIVE COMPARATOR

A handsewn technique will be used during bilioenteric anastomosis.

Procedure: Manual Anastomosis

Interventions

Magnetic Compressive AnastomosisDEVICE

The magnetic compressive anastomosis device will be used to complete the anastomosis during bilioenteric anastomosis.

Magnetic Compressive Anastomosis
Manual AnastomosisPROCEDURE

A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.

Traditional Manual Anastomosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 15849514RESULT

  • 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.

    PMID: 16632990RESULT

  • 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.

    PMID: 8912621RESULT

  • 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.

    PMID: 18161934RESULT

  • 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.

    PMID: 19393505RESULT

  • 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.

    PMID: 15824939RESULT

  • 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.

    PMID: 1294807RESULT

  • 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.

    PMID: 22207929RESULT

MeSH Terms

Conditions

Klatskin TumorCholedochal CystGallstones

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCystsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCholelithiasisCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Yi Lv, MD,PHD

CONTACT

0086-13991200581luyi169@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2016

First Posted

June 16, 2016

Study Start

July 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2019

Last Updated

September 21, 2017

Record last verified: 2017-09

Locations

CN(2)