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| Name | Class |
|---|---|
| Shaanxi Provincial People's Hospital | OTHER |
| Tang-Du Hospital | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| First Affiliated Hospital of Xinjiang Medical University |
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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 superior bilioenteric anastomosis.
The superior 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, thus they are lack of convictive evidence of evidence-based medicine for the security, reliability and convince.
This study is a multicenter, prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive superior bilioenteric anastomosis, this study compared the incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need superior bilioenteric anastomosis operation. The study design plan to enroll 70 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 | Device | The magnetic compressive anastomosis device will be used to complete the anastomosis during bilioenteric anastomosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bilioenteric anastomotic leakage | 1 month post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Length of bilioenteric anastomosis time | during operation | |
| Number of patients who have discharged the device on the date expected. | 1 to 4 weeks postoperation | |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Lv, MD,PHD | Contact | 0086-13991200581 | luyi169@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xian JiaotongUniversity | Recruiting | Xi'an | Shaanxi | 710061 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15849514 | Result | Sicklick JK, Camp MS, Lillemoe KD, Melton GB, Yeo CJ, Campbell KA, Talamini MA, Pitt HA, Coleman J, Sauter PA, Cameron JL. Surgical management of bile duct injuries sustained during laparoscopic cholecystectomy: perioperative results in 200 patients. Ann Surg. 2005 May;241(5):786-92; discussion 793-5. doi: 10.1097/01.sla.0000161029.27410.71. | |
| 16632990 |
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| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| D015529 | Choledochal Cyst |
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| OTHER |
| General Hospital of Ningxia Medical University | OTHER |
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| Manual Anastomosis | Procedure | A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis. |
|
| Number of patients who have been diagnosed as discharge disorder of magnetic device |
| less than 1 week or more than 4 weeks |
| average length of postoperative hospital stay | 3 months |
| Times of pathological examination of bile duct's remnant of Klatskin' tumor | during operation |
| Bilioenteric anastomotic stricture | Time Frame: 1,3,6,12-month post operation |
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
|
| House MG, Cameron JL, Schulick RD, Campbell KA, Sauter PK, Coleman J, Lillemoe KD, Yeo CJ. Incidence and outcome of biliary strictures after pancreaticoduodenectomy. Ann Surg. 2006 May;243(5):571-6; discussion 576-8. doi: 10.1097/01.sla.0000216285.07069.fc. |
| 8912621 | Result | Frattaroli FM, Reggio D, Guadalaxara A, Illomei G, Pappalardo G. Benign biliary strictures: a review of 21 years of experience. J Am Coll Surg. 1996 Nov;183(5):506-13. |
| 18161934 | Result | Yan JQ, Peng CH, Ding JZ, Yang WP, Zhou GW, Chen YJ, Tao ZY, Li HW. Surgical management in biliary restricture after Roux-en-Y hepaticojejunostomy for bile duct injury. World J Gastroenterol. 2007 Dec 28;13(48):6598-602. doi: 10.3748/wjg.v13.i48.6598. |
| 19393505 | Result | Avaliani M, Chigogidze N, Nechipai A, Dolgushin B. Magnetic compression biliary-enteric anastomosis for palliation of obstructive jaundice: initial clinical results. J Vasc Interv Radiol. 2009 May;20(5):614-23. doi: 10.1016/j.jvir.2009.01.019. |
| 15824939 | Result | Chopita N, Vaillaverde A, Cope C, Bernedo A, Martinez H, Landoni N, Jmelnitzky A, Burgos H. Endoscopic gastroenteric anastomosis using magnets. Endoscopy. 2005 Apr;37(4):313-7. doi: 10.1055/s-2005-861358. |
| 1294807 | Result | Stepanov EA, Vasil'ev GS, Nikolaev VV. [The treatment of intestinal fistulae in children by applying a by-pass anastomosis using magnetic devices]. Khirurgiia (Mosk). 1992 Nov-Dec;(11-12):93-5. Russian. |
| 22207929 | Result | Fan C, Ma J, Zhang HK, Gao R, Li JH, Yu L, Wu Z, Lv Y. Sutureless intestinal anastomosis with a novel device of magnetic compression anastomosis. Chin Med Sci J. 2011 Sep;26(3):182-9. doi: 10.1016/s1001-9294(11)60046-1. |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003560 | Cysts |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System 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 |