Clinical trial NCT03117556: Bilateral Thoracoscopic Splanchnicectomy for Pain Relief in Patients With Unresectable Pancreatic Cancer
Official title: Bilateral Thoracoscopic Splanchnicectomy for Pain Relief in Patients With Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Unresectable Pancreatic Cancer
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Norton Healthcare
First posted: 2017-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients with unresectable pancreatic cancer will be considered for participation in this study. Patients with locally advanced or metastatic cancer that meet inclusion criteria will be randomized into one of two arms, treatment with BTS and narcotic analgesia or treatment with narcotic analgesia alone.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to compare the efficacy of bilateral thoracoscopic splanchnicectomy (BTS) to conventional narcotic analgesia for control of abdominal pain in patients with pancreatic ductal adenocarcinoma not amenable to surgical resection.

Detailed description: All patients with unresectable pancreatic cancer will be considered for participation in this study. Patients with locally advanced or metastatic cancer that meet inclusion criteria will be randomized into one of two arms, treatment with BTS and narcotic analgesia or treatment with narcotic analgesia alone. After randomization a baseline pain score will be assessed using the visual analog pain scale. Narcotic dosage and frequency will be evaluated at the time of enrollment. A pre-treatment quality of life score will be recorded using the SF-12® Patient Questionnaire. Patients will also be queried about the presence of nausea and reflux.

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.

Eligibility criteria: Inclusion Criteria:

1. Must be 18 years of age
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:

1. Participating in another clinical trial for the treatment of cancer at the time of screening
2. Pregnant or currently breast feeding

Primary outcomes:
measure: Abdominal pain
timeFrame: 1 year
measure: Daily Narcotic Requirements
timeFrame: 1 year
Secondary outcomes:
measure: Quality of Life Assessment
timeFrame: 1 year
measure: Presence of Nausea
timeFrame: 1 year
measure: Presence of Reflux
timeFrame: 1 Year
measure: Use of Anti-emetics
timeFrame: 1 year
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.