Prospective Study on Endoscopic Ultrasound (EUS) Celiac B... | NCT01318590

Studies
Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis

NCT01318590

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Terminated

Last Update Posted

May 13, 2020Actual

Enrollment

2Actual

Phase

Phase 3

Conditions

Pancreatitis, Chronic

Interventions

EUS procedure with drug injection
EUS procedure

Countries

Belgium
Canada

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

May 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Closed by CHUM REB for incomplete documentation of research activities.

Expanded Access Info

Start Date

Nov 18, 2011Actual

Primary Completion Date

Jun 14, 2019Actual

Completion Date

Jun 14, 2019Actual

First Submitted Date

Mar 17, 2011

First Submission Date that Met QC Criteria

Mar 17, 2011

First Posted Date

Mar 18, 2011Estimated

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

May 12, 2020

Last Update Posted Date

May 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

A Sahai, Gastroenterologist, Centre hospitalier de l'Université de Montréal (CHUM)Principal Investigator

Lead Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)OTHER

Collaborators

Name	Class
Centre de Recherche du Centre Hospitalier de l'Université de Montréal	OTHER
Erasme University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The purpose of this study is to determine if celiac bloc (with injection of steroid and local anesthetic) is superior to a sham procedure for pain control and quality of life improvement in patient with chronic pancreatitis and abdominal pain.

Detailed Description

Chronic pancreatitis is a condition that can lead to very disabling pain symptoms that are difficult to control. The use of morphine is often necessary and also induces a series of secondary symptoms.

In this context, the injection into the celiac plexus block of a local anesthetic has often been proposed as an alternative. This procedure, by interrupting the afferent pain signal of pancreatic origin, aims to reduce pain and improve quality of life at the cost of fewer side effects.

This procedure can be performed transcutaneously using the anatomical landmark or under radiological control. It can also be performed via endosonography (EUS) with better control of the injection site under ultrasound control.

The results of the literature concerning the efficacy of the celiac block in chronic pancreatitis are rather encouraging with reported figures of partial or complete pain control in 39 to 65% of patients [1-7].

However, the number of prospective studies concerning this technique performed endoscopically remains low to date. In particular, there are no case control studies. Data is also poor on the impact on quality of life.

The study proposed here will therefore attempt to provide answers to the questions still pending: is the block by EUS superior to a diagnostic EUS without treatment? ; how long does this treatment last? ; does it have an impact on the quality of life of patients? This study and its draft are inspired by a similar recent study conducted in our department on patients with pancreatic neoplasia. The results of the latter are being submitted for publication.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Celiac bloc	Experimental	The experimental arm will consist of the fractional injection on both sides of the celiac trunk, via EUS, of a local anesthetic (10 ml of Bupivacaine 0.5% (gr / ml)) and an injection of steroids (Triamcinolone 40 mg). In this group antibiotic prophylaxis will be administered after administration of sedation (Cephazolin 1gr IV or Gentamycin).	Drug: EUS procedure with drug injection
Conservative treatment	Sham Comparator	Subject will undergo standard EUS without any additional interventions.	Other: EUS procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EUS procedure with drug injection	Drug	EUS procedure with injection of 10 ml Bupivacaine 0.5% and 40 mg of Triamcinolone in the celiac plexus after administration of intravenous (IV) antibioprophylaxis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain reduction on Likert scale	Pain scale with 7 levels	each month for six months

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life (QOL) score	the digestive disease QOL questionnaire 15 (DDQ-15) is used to analyze QOL	each month for six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

abdominal pain compatible with pancreatic ethiology since at least 3 months
chronic pancreatitis on Computed Tomography (CT), Endoscopic Retrograde Cholangiopancreatography (ERCP) or EUS
EUS feasible
inform consent

Exclusion Criteria:

pregnant women
allergy to local anesthetic
acute pancreatitis in the last 2 weeks
suspicious lesion on pancreatic EUS examination
celiac bloc in the last 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anand V Sahai, MD	CHUM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasme Hospital		Brussels		B1070	Belgium
CHUM

Condition Browse Module

MeSH Terms

ID	Term
D050500	Pancreatitis, Chronic
D015746	Abdominal Pain

Ancestor Terms

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004364	Pharmaceutical Preparations
D002045	Bupivacaine
D014222	Triamcinolone Acetonide

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided