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

Study Overview
=================
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.

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

Conditions
-----------------
Unresectable Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: Bilateral Thoracoscopic Splanchnicectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Participating in another clinical trial for the treatment of cancer at the time of screening Pregnant or currently breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTS Intervention<br>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. | Procedure: Bilateral Thoracoscopic Splanchnicectomy<br>* 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.<br>|
| No Intervention: No BTS Intervention<br>Patients chosen to be treated with narcotic analgesia alone will undergo infusaport placement only. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain | Pain will be measured using a visual analog pain score | 1 year | 
| Daily Narcotic Requirements | Narcotic usage will be monitored at each follow-up visit | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Assessment | Quality of Life will be measured using the SF-12® Patient Questionnaire | 1 year | 
| Presence of Nausea | Patients will be queried about the presence of nausea using a questionnaire | 1 year | 
| Presence of Reflux | Patients will be queried about the presence of reflux using a questionnaire | 1 Year | 
| Use of Anti-emetics | anti-emetic dosage will be measures at each follow-up visit | 1 year |