NCT03886298

Brief Summary

The investigators will evaluate the analgesic efficacy of radiofrequency splanchnic nerve denervation versus neurolytic retrocrural celiac denervation for patients with abdominal pain due to cancer pancreas

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2020

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

March 20, 2019

Last Update Submit

July 3, 2019

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • the percentage of patients that gain more than 50% reduction of their pain on VAS pain score

    VAS pain scale is a tool for measurement of pain intensity scored from 0 to 10 in which 0 + no pain and 10 + the worst pain immaginable

    6 months postoperatively

Study Arms (2)

radiofrequency splanchnic denervation

EXPERIMENTAL
Procedure: radiofrequency splanchnic denervation

retrocrural celiac denervation

ACTIVE COMPARATOR
Procedure: retrocrural celiac denervation

Interventions

radiofrequency splanchnic denervationPROCEDURE

the authors will denervate the splanchnic nerves via radiofrequency

radiofrequency splanchnic denervation
retrocrural celiac denervationPROCEDURE

the authors will denervate the splanchnic nerves in the retrocrural space via injection of alcohol

retrocrural celiac denervation

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with abdominal pain due to cancer pancreas

You may not qualify if:

  • coagulopathy
  • infection at site of the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diab

Asyut, Assuit, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 22, 2019

Study Start

April 10, 2019

Primary Completion

April 10, 2020

Study Completion

June 10, 2020

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

EG(1)