Bilateral Thoracoscopic Splanchnicectomy for Pain Relief in Patients With Unresectable Pancreatic Cancer



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:2/23/2018
Start Date:August 31, 2017
End Date:July 31, 2020
Contact:Gary C Vitale, MD
Email:gcvita01@louisville.edu
Phone:(502) 629-2278

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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.

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.

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
We found this trial at
2
sites
500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Gary C Vitale, MD
Phone: 502-629-2278
University of Louisville The University of Louisville is a state supported research university located in...
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701 Grove Rd
Greenville, South Carolina 29605
(864) 455-7000
Phone: 864-884-0932
Greenville Memorial Hospital Greenville Memorial Medical Campus is a regional referral center for the diagnosis...
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