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Low patient accrual
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The prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and gastric outlet obstruction, is the primary aim of these patients' care. Endoscopic stenting and surgical bypass are currently the two competing treatment options. There is currently no randomized trial comparing the recently developed metal stents to surgical bypass. Furthermore, there is very limited data on quality of life of these patients receiving either therapy. While endoscopic stenting represents the less invasive treatment, surgery may provide better long-term control requiring one-time treatment. Due to the incomplete evidence the present randomized controlled trial is designed to compare quality of life of patients undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused by cancer of the pancreatic head requiring with low bile duct obstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary) |
|
| B | Active Comparator | Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical bypass | Procedure | Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 12 months | |
| Serum bilirubin | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related complications | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Schmied, MD | Department of General, Visceral and Transplantation Surgery, University of Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universityhospital Heidelberg | Heidelberg | 69120 | Germany |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Endoscopic stenting | Procedure | Placement of a biliary metal stent (in combination with a duodenal metal stent in case of gastric outlet obstruction if necessary) |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |