Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure

NCT03792048 | Unknown

• 1 other identifier: XJTU1AF-CRF-2015-001-2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Magnetic anastomosis has been attempted in biliary and intestinal reconstruction. Based on our initial experience, the investigators have successfully utilized magnetic anastomosis for biliojejunostomy and pancreaticojejunostomy during pancreaticoduodenectomy. The current study was to design a prospective and case-control study with utilization of magnetic compression anastomosis for pancreaticojejunostomy and biliojejunostomy in Whipple's procedure versus traditional hand-sewn technique on the postoperative morbidity, such as biliary/pancreatic fistula, hemorrhage, anastomotic stenosis, etc. In addition, the investigators are seeking to assess the safety and formation of the anastomosis by magnetic technique.

Conditions

Cholangiocarcinoma; Pancreatic Neoplasms; Duodenal Neoplasms; Pancreatolithiasis; Chronic Pancreatitis

Keywords

bilioenteric anastomosis; pancreaticojejunostomy; Magnetic Compressive

Outcome Measures

Primary Outcomes (1)

• Incidence of anastomotic fistula

  Incidence of biliary or pancreatic fistula after surgery

  1 month post operation

Secondary Outcomes (5)

• Length of bilio-/pancreaticojejunostomy time

  during operation

• average length of postoperative hospital stay

  1 to 4 weeks postoperation

• Hospitalization cost

  1 to 4 weeks postoperation

• incidence of biliojejunostomic stricture

  12 months post operation

• Incidence of pancreaticojejunostomic stricture

  12 months post operation

Study Arms (2)

Magnetic Compressive Anastomosis

EXPERIMENTAL

A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy

Procedure: Magnetic Compressive Anastomosis

Manual Anastomosis

NO INTERVENTION

Manual Anastomosis for bilioenteric anastomosis and pancreaticojejunostomy

Interventions

Magnetic Compressive Anastomosis PROCEDURE

A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy

Magnetic Compressive 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 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 biliary 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

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

MeSH Terms

Conditions

Cholangiocarcinoma; Pancreatic Neoplasms; Duodenal Neoplasms; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Lv, MD, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Lv, MD,PHD

CONTACT

0086-13991200581; luyi169@126.com

Xu-Feng Zhang, MD, PhD

CONTACT

86-29-85323626; xfzhang125@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: January 3, 2019
• 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 (2)