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Completed

NCT Number: NCT00968175

Endoscopic Ultrasound (EUS) Guided-Celiac Plexus Neurolysis (CPN) in Unresectable Pancreatic Cancer

The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to decreasing the severity of abdominal pain when compared to analgesic therapy alone.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

The specific primary aim of this study is to evaluate the efficacy of EUS-CPN + analgesic therapy (Group 1) in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy (Group 2). The hypothesis will be tested by comparing the changes in reported pain severity between those who receive EUS-CPN in addition to analgesic therapy as compared to analgesic therapy alone.

The secondary aims of this study are to evaluate the efficacy of EUS-CPN + analgesic therapy in improvement of quality of life (QOL) of patients with unresectable pancreatic cancer when compared to when compared with analgesic therapy alone, compare pain medication usage between Group 1 when compared to Group 2, and compare the referral for rescue block during the course of the study between Group 1 and Group 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female
  • Age ≥19 yrs old
  • Abdominal pain typical for pancreatic cancer ≥3/10
  • Abdominal CT radiologically consistent with the diagnosis of pancreatic cancer
  • Pancreatic cancer confirmed by FNA during EUS
  • Inoperability of pancreatic cancer as determined during EUS or prior CT

Exclusion criteria

  • Age < 19 yrs old
  • Unable to safely undergo EUS for any reason
  • Coagulopathy (prolongation of prothrombin time > 18 sec, thrombocytopenia <80,000 platelets/ml)
  • Previous CPN or other neurolytic block that could affect pancreatic cancer -related pain or had implanted epidural or intrathecal analgesic therapy
  • Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
  • Potential patient noncompliance (refusing to follow schedule of events)
  • Active alcohol or other drug use or significant psychiatric illness
  • Pregnant or breastfeeding
  • Unable to consent
  • Non-English speaking

Treatment and study plan

Ultrasound guided celiac plexus neurolysis (CPN)

Procedure

Initial procedure and rescue procedure if applicable

Other names: EUS-CPN

Primary outcomes

  1. The efficacy of EUS-CPN and analgesic therapy in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy

    Time frame: ~ 2 year

Secondary outcomes

  1. To evaluate the efficacy of EUS-CPN and analgesic therapy in improvement of quality of life (QOL)

    Time frame: ~2 year

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • AdventHealth

Registry information

Official study title

EUS Guided-Celiac Plexus Neurolysis (CPN) for Patients With Unresectable Pancreatic Cancer: A Multi-Center, Randomized, Single-Blinded Controlled Trial

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 28, 2009
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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