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The aim of the study is to compare the effect of Roux-en Y reconstruction (study group, DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for DPC. The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE after pancreaticoduodenectomy.
The pancreaticoduodenectomy (DPC) is the procedure of choice of the tumors of the head of the pancreas, periampullary tumors and intractable inflammatory pathology.
The high postoperative morbidity (50%) involve a mean hospital stay of 15 days after surgery. The most common complication is delayed gastric emptying (DGE), defined as the intolerance to solid oral intake by 7th day postoperative. In some severe cases, oral intolerance can occur after the 21th postoperative day. Therefore, the patient requires parenteral nutrition and prolonged hospital stay.
The aim of the study is to compare the effect of Roux-en Y reconstruction (study group, DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for DPC.
The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE after pancreaticoduodenectomy.
A pilot randomized clinical trial has been designed to compare two surgical techniques for reconstruction of digestive tract after DPC in patients treated in our center. The patients are randomized after tumor resection and before the reconstruction througt computer-generated random numbers using a sealed envelope technique. The primary endpoint is the incidence of DGE. Secondary endpoints are postoperative morbidity and specific complications as pancreatic fistula, the hospital stay, and postoperative endocrine and exocrine function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DPC DN | Experimental | Roux-en Y reconstruction after pancreaticoduodenectomy |
|
| DPC UN | Active Comparator | Child reconstruction after pancreaticoduodenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreaticoduodenectomy | Procedure | Pancreaticoduodenectomy is the classical operative technique to resect cephalic pancreatic cancer. In a first phase of the surgery, the resection may be performed. In the second phase, the digestive tract must be restored. We planify two different reconstruction techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Delayed gastric emptying incidence after pancreaticoduodenectomy | DGE, defined as oral diet intolerance from the 7th postoperative day, and the persistence of nasogastric tube on the 4th postoperative day or later, according to the ISGPS criteria | within the first 60 daysafter surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity and complications after pancreaticoduodenectomy | Postoperative morbidity was defined as any complication that appeared during hospital admission. Postoperative complications and postoperative mortality were defined according to the Clavien-Dindo classification. | within the first 60 daysafter surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JULI BUSQUETS | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | Hospitalet Llobregat | Barcelona | 08907 | Spain |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |