EUS Guided Celiac Neurolysis | NCT01615653

Studies
EUS Guided Celiac Neurolysis

NCT01615653

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jul 25, 2017Actual

Enrollment

110Actual

Phase

Not Applicable

Conditions

Pancreatic Cancer Pain

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009Actual

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2015Actual

First Submitted Date

Apr 17, 2012

First Submission Date that Met QC Criteria

Jun 7, 2012

First Posted Date

Jun 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2017

Last Update Posted Date

Jul 25, 2017Actual

Name	Class
American College of Gastroenterology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hypothesis:

- Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
Rationale:
- Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EUS 1	Active Comparator		Procedure: EUS
EUS 2	Active Comparator		Procedure: EUS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EUS	Procedure	EUS Guided Therapy	EUS 1 EUS 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain assessed using a numerical rating scale (NRS) from 0 to 10.	pain response will be measured	Baseline to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
2. Cytologic or histologic confirmation of pancreatic carcinoma
3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
4. EUS clinically indicated (for non-study purposes)

Exclusion Criteria:

1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000
2. Abdominal surgery within 1 month
3. Prior celiac plexus or ganglia neurolysis.
4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55906	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30217513	Derived	Levy MJ, Gleeson FC, Topazian MD, Fujii-Lau LL, Enders FT, Larson JJ, Mara K, Abu Dayyeh BK, Alberts SR, Hallemeier CL, Iyer PG, Kendrick ML, Mauck WD, Pearson RK, Petersen BT, Rajan E, Takahashi N, Vege SS, Wang KK, Chari ST. Combined Celiac Ganglia and Plexus Neurolysis Shortens Survival, Without Benefit, vs Plexus Neurolysis Alone. Clin Gastroenterol Hepatol. 2019 Mar;17(4):728-738.e9. doi: 10.1016/j.cgh.2018.08.040. Epub 2018 Sep 12.

ID	Term
D010190	Pancreatic Neoplasms
D010146	Pain

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms