Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03774589
Other study ID # XJTU1AF-CRF-2015-001-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date January 31, 2022

Study information

Verified date November 2019
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Yi Lv, MD,PHD
Phone 86-29-85323900
Email luyi169@126.com
Is FDA regulated No
Health authority
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 bilioenteric anastomosis.


Description:

The 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. This study is a prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive bilioenteric anastomosis versus traditional suture method on incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need bilioenteric anastomosis operation. The study is to enroll about 200 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 200
Est. completion date January 31, 2022
Est. primary completion date January 31, 2021
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 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.

Study Design


Intervention

Procedure:
Magnetic Compressive Anastomosis
The magnetic compressive anastomosis 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.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University Health Science Center of Xi’an Jiaotong University, Northwest Institute for Non-ferrous Metal Research

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bilioenteric anastomotic leakage To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis 1 month post operation
Secondary Length of bilioenteric anastomosis time To compare the anastomotic time between magnetic and hand-sewn groups during operation
Secondary Time from the date of operation to expel of the magnets. To confirm the safe discharge of the magnets 1 to 4 weeks postoperation
Secondary average length of postoperative hospital stay To compare the length of stay between magnetic and hand-sewn groups 3 months
Secondary Bilioenteric anastomotic stricture To compare the long-term outcome between magnetic and hand-sewn groups 1,3,6,12-month post operation
See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Recruiting NCT06054984 - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04927780 - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer Phase 3
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Terminated NCT03140670 - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy Phase 2
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05168527 - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Recruiting NCT05391126 - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care N/A
Terminated NCT03300921 - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer Phase 1
Completed NCT03153410 - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas Early Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT05679583 - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer Phase 2
Recruiting NCT04183478 - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer Phase 2/Phase 3
Terminated NCT03600623 - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer Early Phase 1
Recruiting NCT04584008 - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics N/A
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Completed NCT04290364 - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study