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

NCT03117556 | Withdrawn

• 1 other identifier: 17.0315
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Unresectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Quality of Life Assessment

  1 year

• Presence of Nausea

  1 year

• Presence of Reflux

  1 Year

• Use of Anti-emetics

  1 year

Study Arms (2)

BTS Intervention

EXPERIMENTAL

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

No BTS Intervention

NO INTERVENTION

Patients chosen to be treated with narcotic analgesia alone will undergo infusaport placement only.

Interventions

Bilateral Thoracoscopic Splanchnicectomy PROCEDURE

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.

BTS Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Louisville: lead
• Norton Healthcare: collaborator

Study Sites (2)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Related Publications (6)

• 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.

  PMID: 23622135 BACKGROUND

• 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.

  PMID: 18506917 BACKGROUND

• 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.

  PMID: 18373443 BACKGROUND

• 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.

  PMID: 26261731 BACKGROUND

• 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.

  PMID: 23572221 BACKGROUND

• 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.

  PMID: 18556993 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medicine, General Surgeon

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 18, 2017
• Study Start: August 31, 2017
• Primary Completion: April 16, 2018
• Study Completion: April 16, 2018
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)