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| Name | Class |
|---|---|
| Xi'an Jiaotong University | OTHER |
| Northwest Institute for Non-ferrous Metal Research | UNKNOWN |
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The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on bilioenteric anastomosis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Compressive Anastomosis | Experimental | A magnetic device will be used during bilioenteric anastomosis. |
|
| Traditional Manual Anastomosis | Active Comparator | A handsewn technique will be used during bilioenteric anastomosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Compressive Anastomosis | Procedure | The magnetic compressive anastomosis will be used to complete the anastomosis during bilioenteric anastomosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bilioenteric anastomotic leakage | To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis | 1 month post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Length of bilioenteric anastomosis time | To compare the anastomotic time between magnetic and hand-sewn groups | during operation |
| Time from the date of operation to expel of the magnets. | To confirm the safe discharge of the magnets |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Lv, MD,PHD | Contact | 86-29-85323900 | luyi169@126.com | |
| Xu-Feng Zhang, MD, PhD | Contact | 86-29-85323626 | xfzhang125@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Lv, MD,PHD | China, Shaanxi First Affiliated Hospital of Xian JiaotongUniversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D018281 | Cholangiocarcinoma |
| D015529 | Choledochal Cyst |
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Manual Anastomosis | Procedure | A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis. |
|
| 1 to 4 weeks postoperation |
| average length of postoperative hospital stay | To compare the length of stay between magnetic and hand-sewn groups | 3 months |
| Bilioenteric anastomotic stricture | To compare the long-term outcome between magnetic and hand-sewn groups | 1,3,6,12-month post operation |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D003560 | Cysts |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004065 | Digestive System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002769 | Cholelithiasis |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |