Clinical trial · Interventional
Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure
Magnetic Compressive Anastomosis for Biliojejunostomy and Pancreaticojejunostomy During Whipple's Procedure: a Prospective Case-control Study
- 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)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Chronic Pancreatitis | — | UNRESOLVED | — |
| Duodenal Neoplasms | Duodenal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatolithiasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Compressive 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 and pancreaticojejunostomy
- interventionNames
- Procedure: Magnetic Compressive Anastomosis
- type
- NO_INTERVENTION
- label
- Manual Anastomosis
- description
- Manual Anastomosis for bilioenteric anastomosis and pancreaticojejunostomy
Primary outcomes (1)
- measure
- Incidence of anastomotic fistula
- timeFrame
- 1 month post operation
- description
- Incidence of biliary or pancreatic fistula after surgery
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 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.
References
Publications (0)
Data not yet available