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Clinical Trials (PDQ®)

EUS Guided Celiac Neurolysis

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedSupportive careClosedNot specifiedOther09-005037
NCT01615653

Trial Description

Summary

  • Hypothesis:
  • Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
  • Rationale:
  • Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.

Eligibility Criteria

Inclusion Criteria:

  • 1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
  • 2. Cytologic or histologic confirmation of pancreatic carcinoma
  • 3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
  • 4. EUS clinically indicated (for non-study purposes)

Exclusion Criteria:

  • 1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000
  • 2. Abdominal surgery within 1 month
  • 3. Prior celiac plexus or ganglia neurolysis.
  • 4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
  • 5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.

Trial Contact Information

Trial Lead Organizations/Sponsors

Mayo Clinic Cancer Center

American College of Gastroenterology

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01615653
ClinicalTrials.gov processed this data on June 05, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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