NCT03070210

Brief Summary

AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided celiac ganglia block (EUS-CGB) vs standard endoscopic ultrasound-guided celiac plexus block (EUS-CPB). METHODS: This is a single-center, double-blind, randomized parallel-group study to assess the efficacy of EUS-CPB vs. EUS-CGB in patients with painful chronic pancreatitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 25, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

2.5 years

First QC Date

February 28, 2017

Last Update Submit

April 15, 2020

Conditions

Pancreatitis, ChronicAbdominal Pain

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    The primary endpoint will be pain relief at 1 week after the block, defined as a decrease of 3 or more points in the VAS scale measuring "average pain over past week".

    1 week

Secondary Outcomes (4)

  • Complete response rate

    1 week

  • Duration of pain relief

    up to 2 months

  • Opioid consumption

    up to 2 months

  • Adverse effects

    in up to 2 months

Study Arms (2)

EUS-celiac plexus block (EUS-CPB)

OTHER

This is the standard technique. In this approach, the needle is passed through the body of the stomach adjacent the celiac artery into the retroperitoneal space in 1 or 2 passes. The injectate (bupivacaine or alcohol) is injected and spreads through the retroperitoneal space, effectively "bathing" all the ganglia.

Procedure: EUS-celiac plexus block (EUS-CPB)

EUS-celiac ganglia block (EUS-CGB)

ACTIVE COMPARATOR

This is a more recent technique which has been often used. In this procedure, the needle is inserted under EUS guidance directly into as many ganglia as possible. For celiac ganglia \<1cm in diameter, the solution is injected into the central point; for those ≥1 cm, a needle is advanced to the deepest point into the ganglia and solution is injected as the needle is slowly withdrawn. Injections are continued until an echogenic pattern is produced over the entire celiac ganglia.

Procedure: EUS-celiac ganglia block (EUS-CGB)

Interventions

EUS-celiac ganglia block (EUS-CGB)PROCEDURE

The intervention technique of EUS-CGB is the realization of EUS-guided celiac block with injection of bupivacaine directly into the ganglia for patients with chronic pancreatitis.

EUS-celiac ganglia block (EUS-CGB)
EUS-celiac plexus block (EUS-CPB)PROCEDURE

In the arm of EUS-CPB, the procedure is going to be performed with the standard EUS-guided celiac plexus block with injection of bupivacaine into the retroperitoneal space.

EUS-celiac plexus block (EUS-CPB)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with chronic pancreatitis and referred for EUS-guided celiac plexus block with: age\>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain.

You may not qualify if:

  • pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (\>1.5) or low platelet count (\<75 cells/mm3), allergy to eggs or "caine" anesthetics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

  • Doi S, Yasuda I, Kawakami H, Hayashi T, Hisai H, Irisawa A, Mukai T, Katanuma A, Kubota K, Ohnishi T, Ryozawa S, Hara K, Itoi T, Hanada K, Yamao K. Endoscopic ultrasound-guided celiac ganglia neurolysis vs. celiac plexus neurolysis: a randomized multicenter trial. Endoscopy. 2013;45(5):362-9. doi: 10.1055/s-0032-1326225. Epub 2013 Apr 24.

    PMID: 23616126BACKGROUND

  • Ascunce G, Ribeiro A, Reis I, Rocha-Lima C, Sleeman D, Merchan J, Levi J. EUS visualization and direct celiac ganglia neurolysis predicts better pain relief in patients with pancreatic malignancy (with video). Gastrointest Endosc. 2011 Feb;73(2):267-74. doi: 10.1016/j.gie.2010.10.029.

    PMID: 21295640BACKGROUND

MeSH Terms

Conditions

Pancreatitis, ChronicAbdominal Pain

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Tyler Stevens, MD

    The Cleveland Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Advanced Endoscopy Fellowship Program

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 3, 2017

Study Start

January 25, 2017

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)