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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02002806

Enrollment

150

Registered

2013-12-06

Start date

2012-01-31

Completion date

2019-06-30

Last updated

2019-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Cancer, Biliary Tract Cancer

Keywords

Pancreatic cancer, Pain

Brief 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.

Interventions

OTHERAlcohol Injection

Celiac plexus neurolysis by alcohol injection

OTHERPlacebo Injection

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Pain Control	12 Months

Secondary

Measure	Time frame
Disease-specific, recurrence-free survival	2 Years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026