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Background: postoperative pancreatic fistula (POPF) remains the most important morbidity after pancreaticoduodenectomy (PD). There is no consensual technique for pancreatic reconstruction and many surgeons use a transanastomotic drain. Currently, the stents used are not degradable and they can cause obstruction, stricture and pancreatitis. The use of biodegradable stents that disappear a few months after the intervention could have a role in the prevention of pancreaticojejunostomy complications.
Material and method: A single-center prospective randomized study was planned with patients undergoing PD. A duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis and the stent is placed from the pancreatic duct to the jejunum.
The primary outcome of the study is the evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biodegradable stent |
| ||
| Non-biodegradable stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodegradable stent | Device | Biodegradable stent (polymeric prostheses) is placed from the pancreatic duct to the jejunum. Duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis. |
| Measure | Description | Time Frame |
|---|---|---|
| POPF | Evaluation of the presence of POPF (drainage fluid amylase value of > 5000 U/L on the first day). | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Position and degradation of biodegradable stents | Evaluation of the position and degradation time of the biodegradable stents | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing cephalic pancreaticoduodenectomy (Whipple procedure).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Ferreras | Recruiting | Murcia | 30120 | Spain |
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| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
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