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

Unresectable Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03117556
• Other study ID #: 17.0315
• Status: Withdrawn
• Phase: N/A
• Start date: August 31, 2017
• Est. completion date: April 16, 2018

Study information

• Verified date: June 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 16, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Unresectable Pancreatic Cancer

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Norton Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

Gachago C, Draganov PV. Pain management in chronic pancreatitis. World J Gastroenterol. 2008 May 28;14(20):3137-48. Review. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal pain	Pain will be measured using a visual analog pain score	1 year
Primary	Daily Narcotic Requirements	Narcotic usage will be monitored at each follow-up visit	1 year
Secondary	Quality of Life Assessment	Quality of Life will be measured using the SF-12® Patient Questionnaire	1 year
Secondary	Presence of Nausea	Patients will be queried about the presence of nausea using a questionnaire	1 year
Secondary	Presence of Reflux	Patients will be queried about the presence of reflux using a questionnaire	1 Year
Secondary	Use of Anti-emetics	anti-emetic dosage will be measures at each follow-up visit	1 year