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Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Pancreatic Neoplasms Biliary Tract Neoplasms Pancreatitis, Chronic Duodenal Neoplasms | Procedure: pancreaticojejunostomy | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (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 ]
- postoperative hospital stay time; [ Time Frame: 90 days ]
- anastomosis time; [ Time Frame: 1 hour ]
- reoperation rate; [ Time Frame: 30 days ]
- morbidity and mortality [ Time Frame: 90 days ]
| Enrollment: | 308 |
| Study Start Date: | October 2012 |
| Study Completion Date: | October 2014 |
| Primary Completion Date: | June 2014 (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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01731821
| China, Shanghai | |
| Fudan University Shanghai Cancer Center | |
| Shanghai, Shanghai, China, 200032 | |
| Principal Investigator: | Xian-Jun Yu, M.D. | Department of Pancreatic & Hepatobiliary Surgery |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | December 2, 2014 |
Keywords provided by Xian-Jun Yu, Fudan University:
|
Pancreaticoduodenectomy Pancreaticojejunostomy |
Additional relevant MeSH terms:
|
Neoplasms Pancreatitis Pancreatic Neoplasms Biliary Tract Neoplasms Pancreatitis, Chronic Duodenal Neoplasms Pancreatic Diseases Digestive System Diseases Digestive System Neoplasms |
Neoplasms by Site Endocrine Gland Neoplasms Endocrine System Diseases Biliary Tract Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on August 18, 2017