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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure: a Prospective Case-control Study

Conditions
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Cholangiocarcinoma, Pancreatic Neoplasms, Duodenal Neoplasms, Pancreatolithiasis, Chronic Pancreatitis

Intervention / Treatment
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* Procedure: Magnetic Compressive Anastomosis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic Compressive Anastomosis<br>A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy | Procedure: Magnetic Compressive Anastomosis<br>* A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy<br>|
| No Intervention: Manual Anastomosis<br>Manual Anastomosis for bilioenteric anastomosis and pancreaticojejunostomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of anastomotic fistula | Incidence of biliary or pancreatic fistula after surgery | 1 month post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of bilio-/pancreaticojejunostomy time | Separate operation time of magnetic anastomosis for bilio- and pancreaticojejunostomy | during operation | 
| average length of postoperative hospital stay | length of hospital stay (days) after surgery | 1 to 4 weeks postoperation | 
| Hospitalization cost | cost in hospital | 1 to 4 weeks postoperation | 
| incidence of biliojejunostomic stricture | Incidence of biliojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up | 12 months post operation | 
| Incidence of pancreaticojejunostomic stricture | Incidence of pancreaticojejunostomic stricture between magnetic and manual groups during the relatively long-term follow-up | 12 months post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bilioenteric anastomosis, pancreaticojejunostomy, Magnetic Compressive