Bilateral Thoracoscopic Splanchnicectomy for Pain Relief in Patients With Unresectable Pancreatic Cancer
NCT ID: NCT03117556
Last Updated: 2021-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-08-31
2018-04-16
Brief Summary
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Detailed Description
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After all baseline assessments are complete patients will be taken to the OR to undergo their assigned procedure. BTS and infusaport placement will be performed on patients randomly selected for treatment with BTS and narcotic analgesia. BTS will be performed as described in the study procedure. Patients chosen to be treated with narcotic analgesia alone will undergo infusaport placement only. An evaluation will be completed postoperatively in which the length of stay, post-op complications, and chest X-ray results will be recorded. Follow-up assessments will be conducted 24-48 hours post-procedure and at the time of discharge. Further follow-up assessments will be conducted 14 days, 30 days, and 90 days post-procedure during an office visit with the clinical research team or medical oncology.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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BTS Intervention
Bilateral thoracoscopic splanchnicectomy and infusaport placement will be performed on patients randomly selected for treatment with BTS and narcotic analgesia. Narcotics will still be prescribed for pain as needed.
Bilateral Thoracoscopic Splanchnicectomy
BTS will be performed on all patients under general endotracheal anesthesia. Patients will be placed in the prone position. A 5 mm trocar should be placed at the inferior scapular apex on the patient's left side. After confirmation of trocar placement with a 30 degree 5 mm thoracoscope, a second trocar will be placed two intercostal spaces below and two cm medial to the first trocar. After the splanchnic nerves are identified inferior and medial to the sympathetic trunk, the pleura will be incised on both sides of each of the nerves. Skin incisions are then closed and the procedure will then be repeated on the patient's right side.
No BTS Intervention
Patients chosen to be treated with narcotic analgesia alone will undergo infusaport placement only.
No interventions assigned to this group
Interventions
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Bilateral Thoracoscopic Splanchnicectomy
BTS will be performed on all patients under general endotracheal anesthesia. Patients will be placed in the prone position. A 5 mm trocar should be placed at the inferior scapular apex on the patient's left side. After confirmation of trocar placement with a 30 degree 5 mm thoracoscope, a second trocar will be placed two intercostal spaces below and two cm medial to the first trocar. After the splanchnic nerves are identified inferior and medial to the sympathetic trunk, the pleura will be incised on both sides of each of the nerves. Skin incisions are then closed and the procedure will then be repeated on the patient's right side.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with stage III/IV pancreatic cancer
3. Willing and able to comply with the protocol requirements
4. Able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study
Exclusion Criteria
2. Pregnant or currently breast feeding
18 Years
ALL
No
Sponsors
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Norton Healthcare
OTHER
University of Louisville
OTHER
Responsible Party
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Gary C. Vitale, MD
Professor of medicine, General Surgeon
Locations
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University of Louisville
Louisville, Kentucky, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Countries
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References
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Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.
Gachago C, Draganov PV. Pain management in chronic pancreatitis. World J Gastroenterol. 2008 May 28;14(20):3137-48. doi: 10.3748/wjg.14.3137.
Katri KM, Ramadan BA, Mohamed FS. Thoracoscopic splanchnicectomy for pain control in irresectable pancreatic cancer. J Laparoendosc Adv Surg Tech A. 2008 Apr;18(2):199-203. doi: 10.1089/lap.2007.0066.
Jones WB, Jordan P, Pudi M. Pain management of pancreatic head adenocarcinomas that are unresectable: celiac plexus neurolysis and splanchnicectomy. J Gastrointest Oncol. 2015 Aug;6(4):445-51. doi: 10.3978/j.issn.2078-6891.2015.052.
Malec-Milewska MB, Tarnowski W, Ciesielski AE, Michalik E, Guc MR, Jastrzebski JA. Prospective evaluation of pain control and quality of life in patients with chronic pancreatitis following bilateral thoracoscopic splanchnicectomy. Surg Endosc. 2013 Oct;27(10):3639-45. doi: 10.1007/s00464-013-2937-0. Epub 2013 Apr 10.
Davis BR, Vitale M, Lecompte M, Vitale D, Vitale GC. An objective study of pain relief in chronic pancreatitis from bilateral thoracoscopic splanchnicectomy. Am Surg. 2008 Jun;74(6):510-4; discussion 514-5.
Other Identifiers
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17.0315
Identifier Type: -
Identifier Source: org_study_id
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