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

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ClinicalTrials.gov Identifier: NCT03792048
Recruitment Status : Not yet recruiting
First Posted : January 3, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Pancreatic Neoplasms Duodenal Neoplasms Pancreatolithiasis Chronic Pancreatitis Procedure: Magnetic Compressive Anastomosis Not Applicable

Detailed Description:
The magnets used in the current study consists of a mother and daughter magnets. An 8-Fr nasogastric tube is tightly fixed with the mother magnet, which will be used for bile or pancreatic drainage before formation of anastomoses. The outside diameter (OD) of the magnets ranges from 5mm to 15mm. In fact, for biliojejunostomy, larger magnets are applied, whereas for pancreaticojejunostomy, smaller magnets are routinely used. This study is a single-center, parallel controlled trial to evaluate the safety and effectiveness of magnetic compression technique for biliojejunostomy and pancreaticojejunostomy, versus traditional hand-sewn techniques on the postoperative morbidity of the patients. And also how to avoid mutual attraction of the two pairs of magnets, formation of bilio-/pancreaticojejunostomy time, discharge rule of the magnets will be all evaluated in the current study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure: a Prospective Case-control Study
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2022


Arm Intervention/treatment
Experimental: Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy
Procedure: Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy

No Intervention: Manual Anastomosis
Manual Anastomosis for bilioenteric anastomosis and pancreaticojejunostomy



Primary Outcome Measures :
  1. Incidence of anastomotic fistula [ Time Frame: 1 month post operation ]
    Incidence of biliary or pancreatic fistula after surgery


Secondary Outcome Measures :
  1. Length of bilio-/pancreaticojejunostomy time [ Time Frame: during operation ]
    Separate operation time of magnetic anastomosis for bilio- and pancreaticojejunostomy

  2. average length of postoperative hospital stay [ Time Frame: 1 to 4 weeks postoperation ]
    length of hospital stay (days) after surgery

  3. Hospitalization cost [ Time Frame: 1 to 4 weeks postoperation ]
    cost in hospital

  4. incidence of biliojejunostomic stricture [ Time Frame: 12 months post operation ]
    Incidence of biliojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up

  5. Incidence of pancreaticojejunostomic stricture [ Time Frame: 12 months post operation ]
    Incidence of pancreaticojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792048


Contacts
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Contact: Yi Lv, MD,PHD 0086-13991200581 luyi169@126.com
Contact: Xu-Feng Zhang, MD, PhD 86-29-85323626 xfzhang125@126.com

Locations
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China, Shaanxi
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, China, 710061
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: Yi Lv, MD, PhD First Affiliated Hospital Xi'an Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03792048     History of Changes
Other Study ID Numbers: XJTU1AF-CRF-2015-001-2
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
bilioenteric anastomosis
pancreaticojejunostomy
Magnetic Compressive

Additional relevant MeSH terms:
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Neoplasms
Pancreatitis
Cholangiocarcinoma
Pancreatitis, Chronic
Pancreatic Neoplasms
Duodenal Neoplasms
Pancreatic Diseases
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases