Bilioenteric Anastomosis by Magnetic Compressive Technique

NCT03774589 | Unknown

• 1 other identifier: XJTU1AF-CRF-2015-001-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on bilioenteric anastomosis.

Conditions

Pancreatic Cancer; Cholangiocarcinoma; Bile Duct Injury; Choledochal Cyst; Biliary Calculi

Keywords

bilioenteric anastomosis; magnetic compressive technique; morbidity

Outcome Measures

Primary Outcomes (1)

• Bilioenteric anastomotic leakage

  To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis

  1 month post operation

Secondary Outcomes (4)

• Length of bilioenteric anastomosis time

  during operation

• Time from the date of operation to expel of the magnets.

  1 to 4 weeks postoperation

• average length of postoperative hospital stay

  3 months

• Bilioenteric anastomotic stricture

  1,3,6,12-month post operation

Study Arms (2)

Magnetic Compressive Anastomosis

EXPERIMENTAL

A magnetic device will be used during bilioenteric anastomosis.

Procedure: Magnetic Compressive Anastomosis

Traditional Manual Anastomosis

ACTIVE COMPARATOR

A handsewn technique will be used during bilioenteric anastomosis.

Procedure: Manual Anastomosis

Interventions

Magnetic Compressive Anastomosis PROCEDURE

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

Magnetic Compressive Anastomosis

Manual Anastomosis PROCEDURE

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

Traditional Manual Anastomosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Xi'an Jiaotong University: collaborator
• Northwest Institute for Non-ferrous Metal Research: collaborator

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Cholangiocarcinoma; Choledochal Cyst; Gallstones

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Cysts; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cholelithiasis; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Lv, MD,PHD

  China, Shaanxi First Affiliated Hospital of Xian JiaotongUniversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Lv, MD,PHD

CONTACT

86-29-85323900; luyi169@126.com

Xu-Feng Zhang, MD, PhD

CONTACT

86-29-85323626; xfzhang125@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: December 12, 2018
• First Posted: December 13, 2018
• Study Start: February 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2022
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

CN (1)