Clinical trial · Interventional
Superior Bilioenteric Anastomosis by Magnetic Compressive Technique
Superior Bilioenteric Anastomosis by Magnetic Compressive Technique: A Multicenter, Prospective, Randomized Controlled Trial
NCT02801500CI-TRIAL-00029625CTREGunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Injury | — | UNRESOLVED | — |
| Biliary Calculi | — | UNRESOLVED | — |
| Choledochal Cyst | — | UNRESOLVED | — |
| Hilar Cholangiocarcinoma | Hilar Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Compressive Anastomosis | Device | — | UNRESOLVED |
| Manual Anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Magnetic Compressive Anastomosis
- description
- A magnetic device will be used during bilioenteric anastomosis.
- interventionNames
- Device: Magnetic Compressive Anastomosis
- type
- ACTIVE_COMPARATOR
- label
- Traditional Manual Anastomosis
- description
- A handsewn technique will be used during bilioenteric anastomosis.
- interventionNames
- Procedure: Manual Anastomosis
Primary outcomes (1)
- measure
- Bilioenteric anastomotic leakage
- timeFrame
- 1 month post operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with age between 18 to 75 * Patients' gender was not limited * Patients who were well-diagnosed and had the indication for superior bilioenteric 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 hepatic 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.
References
Publications (8)
- RESULTSicklick 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. PMID 15849514
- RESULTHouse 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. PMID 16632990
- RESULTFrattaroli 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. PMID 8912621
- RESULTYan 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. PMID 18161934
- RESULTAvaliani 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. PMID 19393505
- RESULTChopita 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. PMID 15824939
- RESULTStepanov 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.