Endoscopic Radiofrequency Ablation of Celiac Ganglion for Pain Management and Improvement of Quality of Life in Patients With Unresectable Pancreatic Cancer

Study Purpose

This study aims to evaluate the EUS-RFA in terms of efficacy for pain management and improvement in quality-of-life parameters for patients with advanced inoperable pancreatic cancer. The primary objectives of this study are to 1) evaluate the utility of EUS-RFA for pain control and improvement in quality-of-life parameters for patients with advanced pancreatic cancer; 2) to measure the reduction of analgesic medications' requirements in patients affected by inoperable pancreatic cancer.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of pancreatic cancer based on clinical, radiological, or pathological assessment; - Referred for abdominal and/or back pain due to pancreatic cancer; - No prior history of RFA; - Cancer pain unresponsive to the WHO 3-step analgesic ladder; - Willingness to consent to participate in the study.

Exclusion Criteria:

  • - Patients who are not willing to give informed consent or agree to participate in the study.
  • - Surgically resectable pancreatic cancer; - Abdominal pain with etiology other than pancreatic malignancy; - Evidence of concurrent infection; - Patients with irreversible coagulopathy international normalized ratio >1.5 or platelet count <50,000/mm3), - Patients with a preliminary diagnosis of adenocarcinoma are not possible established with intraprocedural at EUS-guided FNA.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05535894
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

West Virginia University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Shailendra Singh, MD
Principal Investigator Affiliation West Virginia University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pancreatic Cancer
Arms & Interventions

Arms

: Unresectable Pancreatic Cancer

Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion

Interventions

Procedure: - Ablation of Celiac Ganglion

Endoscopic Ultrasound-guided Radiofrequency Ablation of Celiac Ganglion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Shailendra Singh, Morgantown, West Virginia

Status

Recruiting

Address

Shailendra Singh

Morgantown, West Virginia, 26508

Site Contact

Shailendra Singh, MD

shailendra.singh@hsc.wvu.edu

304-293-4123

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