Intraoperative Celiac Plexus Neurolysis for Patients With Operable Pancreatic and Periampullary Cancer
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| ClinicalTrials.gov Identifier: NCT00806611 |
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Recruitment Status :
Completed
First Posted : December 11, 2008
Last Update Posted : October 21, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Cancer | Procedure: Alcohol Block | Phase 3 |
Pancreatic adenocarcinoma is the fourth leading cause of cancer related death in the United States and is usually fatal. Surgery provides the only chance for long-term survival. Pain is a significant, often difficult to control component of survivorship for many who succumb to this disease. The purpose of this trial is to evaluate the effect of ethanol celiac plexus neurolysis (alcohol nerve block) in patients undergoing surgical intervention for pancreatic cancer. Patients undergoing surgery for pancreatic cancer will be enrolled in a prospective randomized double blind placebo controlled clinical trial.
This protocol is designed to definitively determine the role of ethanol celiac plexus neurolysis as a simple addition to the surgical management of pancreatic adenocarcinoma and help define the standard of care for cancer associated pain management in this disease.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 438 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Supportive Care |
| Official Title: | A Randomized, Controlled Trial of Intraoperative Celiac Plexus Neurolysis for Patients With Operable (Resectable and Unresectable) Pancreatic and Periampullary Cancer |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | April 2013 |
| Actual Study Completion Date : | April 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 50% Ethanol
Operating surgeon injects 20 ml of 50% ethanol on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
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Procedure: Alcohol Block
Operating surgeon by injecting 20 ml of either 50% ethanol or saline on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
Other Name: ethanol celiac plexus neurolysis |
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Placebo Comparator: Placebo
Operating surgeon injects 20 ml of saline on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
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Procedure: Alcohol Block
Operating surgeon by injecting 20 ml of either 50% ethanol or saline on each side of the aorta at the level of the celiac axis with a 20 or 22 gauge spinal needle
Other Name: ethanol celiac plexus neurolysis |
- The primary endpoint is cancer related pain control. [ Time Frame: Increased pain at 12 months in subjects with resectable tumors; increased pain at 3 months in subjects with unresectable tumors ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Preoperative imaging indicates possibility of resectable pancreatic cancer
- Intraoperative biopsy histologically confirming pancreatic adenocarcinoma
Exclusion Criteria:
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): NCT00806611
| United States, Pennsylvania | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Principal Investigator: | Harish Lavu, MD | Thomas Jefferson University |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sidney Kimmel Cancer Center at Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00806611 History of Changes |
| Other Study ID Numbers: |
08D.380 2007-32 ( Other Identifier: CCRRC ) |
| First Posted: | December 11, 2008 Key Record Dates |
| Last Update Posted: | October 21, 2016 |
| Last Verified: | October 2016 |
Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
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pancreatic cancer periampullary cancer resectable |
unresectable celiac plexus neurolysis surgery |
Additional relevant MeSH terms:
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases |
Endocrine System Diseases Ethanol Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs |