Bilateral Thoracoscopic Splanchnicectomy for Pain Relief in Patients With Unresectable Pancreatic Cancer
- Conditions
- Unresectable Pancreatic Cancer
- Interventions
- Procedure: Bilateral Thoracoscopic Splanchnicectomy
- Registration Number
- NCT03117556
- Lead Sponsor
- University of Louisville
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Must be 18 years of age
- Diagnosed with stage III/IV pancreatic cancer
- Willing and able to comply with the protocol requirements
- Able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study
- Participating in another clinical trial for the treatment of cancer at the time of screening
- Pregnant or currently breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BTS Intervention Bilateral Thoracoscopic Splanchnicectomy 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.
- Primary Outcome Measures
Name Time Method Abdominal pain 1 year Pain will be measured using a visual analog pain score
Daily Narcotic Requirements 1 year Narcotic usage will be monitored at each follow-up visit
- Secondary Outcome Measures
Name Time Method Presence of Nausea 1 year Patients will be queried about the presence of nausea using a questionnaire
Quality of Life Assessment 1 year Quality of Life will be measured using the SF-12® Patient Questionnaire
Presence of Reflux 1 Year Patients will be queried about the presence of reflux using a questionnaire
Use of Anti-emetics 1 year anti-emetic dosage will be measures at each follow-up visit
Trial Locations
- Locations (2)
University of Louisville
🇺🇸Louisville, Kentucky, United States
Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States