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This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.
Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct cancer.
Subjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with ethanol injection versus surgery plus placebo injection. Subjects will be followed every three months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of pain control will be determined at one year post surgery. Subjects are not required to undergo any additional diagnostic testing procedures that are not part of their routine follow-up care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol Injection | Experimental | Celiac plexus neurolysis by alcohol injection One time administration during surgery 20 ml of alcohol injection on each side of aorta at level of celiac axis |
|
| Placebo Injection | Placebo Comparator | Celiac plexus injection - placebo injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol Injection | Other | Celiac plexus neurolysis by alcohol injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Control | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-specific, recurrence-free survival | 2 Years |
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Inclusion Criteria:
This study will be offered to all patients scheduled to undergo open or laparoscopic operative resection of a presumed pancreatic (any location; i.e., head, body, or tail) or distal biliary tract cancer.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael G House, MD | Indiana University, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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| Placebo Injection | Other |
|
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012996 |
| Solutions |
| D004364 | Pharmaceutical Preparations |