Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy
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Purpose
Pancreaticojejunostomy is the key procedure of pancreaticoduodenectomy. The aim of our study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named "nonstented stump-closed pancreaticojejunostomy" in pancreatoduodenectomy, which could provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Neoplasms Biliary Tract Neoplasms Pancreatitis, Chronic Duodenal Neoplasms |
Procedure: pancreaticojejunostomy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Clinical Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy: Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy |
- the postoperative pancreatic fistula(POPF) rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- postoperative hospital stay time; [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- anastomosis time; [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- reoperation rate; [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- morbidity and mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 308 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nonstented stump-closed anastomosis
Nonstented stump-closed anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.
|
Procedure: pancreaticojejunostomy
Nonstented stump closed pancreaticojejunostomy: Close the pancreatic stump with interrupted inverting sutures around the "papillary-like" pancreatic duct. A small full-thickness enterotomy was penetrated on the jejunal wall for connecting to the "papillary-like" pancreatic duct by placing 4-6 sutures from the "periductal" parenchyma to the whole-layer jejunum hole. After that, interrupted sutures between the front wall of pancreatic stump and the seromuscular jejunum were performed by 4-0 absorbable sutures to complete the anastomosis. Duct-to-mucosa pancreaticojejunostomy:Two layer anatomosis with "Duct-to-Mucosa" pancreaticojejunostomy is performed by suturing the pancreatic parenchyma to the jejunal seromuscular layer and no stenting tube was used. |
|
Active Comparator: Duct-to-mucosa anastomosis
Duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy.
|
Procedure: pancreaticojejunostomy
Nonstented stump closed pancreaticojejunostomy: Close the pancreatic stump with interrupted inverting sutures around the "papillary-like" pancreatic duct. A small full-thickness enterotomy was penetrated on the jejunal wall for connecting to the "papillary-like" pancreatic duct by placing 4-6 sutures from the "periductal" parenchyma to the whole-layer jejunum hole. After that, interrupted sutures between the front wall of pancreatic stump and the seromuscular jejunum were performed by 4-0 absorbable sutures to complete the anastomosis. Duct-to-mucosa pancreaticojejunostomy:Two layer anatomosis with "Duct-to-Mucosa" pancreaticojejunostomy is performed by suturing the pancreatic parenchyma to the jejunal seromuscular layer and no stenting tube was used. |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed consent
- 18-80 years old;
- Eastern Cooperative Oncology Group(ECOG) 0-2
- Patients must have undergone pancreaticoduodenectomy.
- Preoperative enhanced CT scan shows respectable or borderline resectable neoplasm
- Without distal metastasis
Exclusion Criteria:
- Patients who have had previous pancreatic body tail resection rese
- immunodeficiency, people infected with HIV
- patients with severe cardiopulmonary function, liver and renal function
- infection without control or active infections
- Pregnant patients.
Contacts and Locations| Contact: Xian-Jun Yu, M.D. | +86 21 64175590 ext 1305 | yuxianjun88@hotmail.com |
| China, Shanghai | |
| Fudan University Shanghai Cancer Center | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Chen Liu, M.D. +86 21 64175590 ext 1305 blurlc@hotmail.com | |
| Principal Investigator: Xian-Jun Yu, M.D. | |
| Principal Investigator: | Xian-Jun Yu, M.D. | Department of Pancreatic & Hepatobiliary Surgery |
More Information
No publications provided
| Responsible Party: | Xian-Jun Yu, Professor and Chair,Department of Pancreatic & Hepatobiliary Surgery, Fudan University |
| ClinicalTrials.gov Identifier: | NCT01731821 History of Changes |
| Other Study ID Numbers: | PCI001 |
| Study First Received: | November 10, 2012 |
| Last Updated: | November 17, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Fudan University:
|
Pancreaticoduodenectomy Pancreaticojejunostomy |
Additional relevant MeSH terms:
|
Duodenal Diseases Biliary Tract Neoplasms Neoplasms Duodenal Neoplasms Pancreatic Neoplasms Pancreatitis Pancreatitis, Chronic Digestive System Neoplasms Neoplasms by Site |
Biliary Tract Diseases Digestive System Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Gastrointestinal Diseases Intestinal Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013