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Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control | Clinical Trials | Clareo Health

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Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control

A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies

NCT02002806•Indiana University

View on ClinicalTrials.gov

Summary

This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.

Detailed Description

Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct cancer. Subjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with ethanol injection versus surgery plus placebo injection. Subjects will be followed every three months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of pain control will be determined at one year post surgery. Subjects are not required to undergo any additional diagnostic testing procedures that are not part of their routine follow-up care.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•This study will be offered to all patients scheduled to undergo open or laparoscopic operative resection of a presumed pancreatic (any location; i.e., head, body, or tail) or distal biliary tract cancer.
•Physiologic suitability for major abdominal surgery
•Aged 18 years and older
•Written informed consent
•Ability to understand and comply with study guidelines.

Exclusion Criteria

•Pregnancy
•Previous, preoperative celiac nerve block
•Neoadjuvant chemotherapy or radiation therapy
•Incomplete tumor resection (R2 resection, grossly positive resection margin)
•Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative findings
•Benign tumors, neuroendocrine tumors, soft tissue tumors based on preoperative work-up or intraoperative findings
•Known metastatic disease

Locations (1)

Indiana University

Indianapolis, Indiana, United States

Key Dates

Start Date

January 1, 2012

Primary Completion Date

December 1, 2018

Completion Date

June 1, 2019

Last Updated

August 16, 2019

Enrollment

150

ACTUAL participants

Conditions

Pancreas CancerBiliary Tract Cancer

Interventions

Alcohol Injection

OTHER

Placebo Injection

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 16, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control

Inclusion Criteria

Exclusion Criteria

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

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