Nonstented Stump-closed vs Duct-to-Mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy
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| ClinicalTrials.gov Identifier: NCT01731821 |
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Recruitment Status :
Completed
First Posted : November 22, 2012
Last Update Posted : December 4, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Neoplasms Biliary Tract Neoplasms Pancreatitis, Chronic Duodenal Neoplasms | Procedure: pancreaticojejunostomy | Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 308 participants |
| 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 |
| Study Start Date : | October 2012 |
| Actual Primary Completion Date : | June 2014 |
| Actual Study Completion Date : | October 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Nonstented stump-closed anastomosis
Nonstented stump-closed anastomosis is used for pancreaticojejunostomy after pancreaticoduodenectomy.
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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. |
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Active Comparator: Duct-to-mucosa anastomosis
Duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy.
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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. |
- 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 ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731821
| China, Shanghai | |
| Fudan University Shanghai Cancer Center | |
| Shanghai, Shanghai, China, 200032 | |
| Principal Investigator: | Xian-Jun Yu, M.D. | Department of Pancreatic & Hepatobiliary Surgery |
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 |
| First Posted: | November 22, 2012 Key Record Dates |
| Last Update Posted: | December 4, 2014 |
| Last Verified: | December 2014 |
Keywords provided by Xian-Jun Yu, Fudan University:
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Pancreaticoduodenectomy Pancreaticojejunostomy |
Additional relevant MeSH terms:
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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 |