Endoscopic Ultrasound (EUS) Guided-Celiac Plexus Neurolysis (CPN) in Unresectable Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to decreasing the severity of abdominal pain when compared to analgesic therapy alone.

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Detailed Description

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The specific primary aim of this study is to evaluate the efficacy of EUS-CPN + analgesic therapy (Group 1) in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy (Group 2). The hypothesis will be tested by comparing the changes in reported pain severity between those who receive EUS-CPN in addition to analgesic therapy as compared to analgesic therapy alone.

The secondary aims of this study are to evaluate the efficacy of EUS-CPN + analgesic therapy in improvement of quality of life (QOL) of patients with unresectable pancreatic cancer when compared to when compared with analgesic therapy alone, compare pain medication usage between Group 1 when compared to Group 2, and compare the referral for rescue block during the course of the study between Group 1 and Group 2

Conditions

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Pain Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group 1: CPN + analgesic therapy

Receives ultrasound guided celiac plexus neurolysis (CPN) in addition to standard analgesic therapy

Group Type ACTIVE_COMPARATOR

Ultrasound guided celiac plexus neurolysis (CPN)

Intervention Type PROCEDURE

Initial procedure and rescue procedure if applicable

Analgesic therapy alone

Will not receive ultrasound guided celiac plexus neurolysis (CPN); only standard analgesic therapy for pain management

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound guided celiac plexus neurolysis (CPN)

Initial procedure and rescue procedure if applicable

Intervention Type PROCEDURE

Other Intervention Names

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EUS-CPN

Eligibility Criteria

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Inclusion Criteria

1. Male or Female
2. Age ≥19 yrs old
3. Abdominal pain typical for pancreatic cancer ≥3/10
4. Abdominal CT radiologically consistent with the diagnosis of pancreatic cancer
5. Pancreatic cancer confirmed by FNA during EUS
6. Inoperability of pancreatic cancer as determined during EUS or prior CT

Exclusion Criteria

1. Age \< 19 yrs old
2. Unable to safely undergo EUS for any reason
3. Coagulopathy (prolongation of prothrombin time \> 18 sec, thrombocytopenia \<80,000 platelets/ml)
4. Previous CPN or other neurolytic block that could affect pancreatic cancer -related pain or had implanted epidural or intrathecal analgesic therapy
5. Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
6. Potential patient noncompliance (refusing to follow schedule of events)
7. Active alcohol or other drug use or significant psychiatric illness
8. Pregnant or breastfeeding
9. Unable to consent
10. Non-English speaking

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No