Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Compressive Anastomosis | Experimental | A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy |
|
| Manual Anastomosis | No Intervention | Manual Anastomosis for bilioenteric anastomosis and pancreaticojejunostomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Compressive Anastomosis | Procedure | A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anastomotic fistula | Incidence of biliary or pancreatic fistula after surgery | 1 month post operation |
| 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 |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Lv, MD,PHD | Contact | 0086-13991200581 | luyi169@126.com | |
| Xu-Feng Zhang, MD, PhD | Contact | 86-29-85323626 | xfzhang125@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Lv, MD, PhD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xian JiaotongUniversity | Recruiting | Xi'an | Shaanxi | 710061 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
|
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D010190 | Pancreatic Neoplasms |
| D004379 | Duodenal Neoplasms |
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D010195 | Pancreatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided