UMIN-CTR Clinical Trial

Public title

Efficacy and Safety of Endoscopic Ultrasound Guided Central versus Bilateral Celiac Plexus Neurolysis for Managing Abdominal Pain Associated with Pancreatic Cancer

Acronym

Endoscopic Ultrasound Guided Central versus Bilateral Celiac Plexus Neurolysis for Managing Abdominal Pain Associated with Pancreatic Cancer

Scientific Title

Efficacy and Safety of Endoscopic Ultrasound Guided Central versus Bilateral Celiac Plexus Neurolysis for Managing Abdominal Pain Associated with Pancreatic Cancer

Scientific Title:Acronym

Endoscopic Ultrasound Guided Central versus Bilateral Celiac Plexus Neurolysis for Managing Abdominal Pain Associated with Pancreatic Cancer

Region

Africa

Condition

is EUS Guided Safe and effective in managing pancreatic cancer pain and with method is better ( Central VS Bilateral
and what is the best time for intervention early or late salvage therapy ?

Classification by specialty

Gastroenterology

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

aim of this study is to compare central endoscopic ultrasound guided
versus bilateral celiac plexus neurolysis using absolute alcohol for pain control with pancreatic cancer

Basic objectives2

Others

Basic objectives -Others

the optimal time for intervention early vs late salvage therapy

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Primary outcomes

central endoscopic ultrasound guided
versus bilateral celiac plexus neurolysis using absolute alcohol for pain control with pancreatic cancer which is better ?
by assessing pain duration before the procedure, the
dose and type of analgesic used, and visual analog scale pain score pre and
post-treatment at day 7th , 14th and after two months.

Key secondary outcomes

The best Time of intervention early or salvage therapy
Decreased requirement for analgesics

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

First group
- central Endoscopic Ultrasound guided celiac nerve neurolysis in managing pain in patient
with pancreatic cancer

Interventions/Control_2

second group
- bilateral Endoscopic Ultrasound guided celiac nerve neurolysis in managing pain in patient
with pancreatic cancer

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

- age older than 18 years;
- Severe abdominal or back pain due to confirmed pancreatic cancer
(surgical biopsy or EUS-FNA) .
- Presence of unrespectable pancreatic cancer (distant metastasis; the
invasion of celiac trunk or superior mesentery artery) or intolerability to
3
surgery because of other systemic disorders.
- Informed consent.

Key exclusion criteria

- Patients whose general condition cannot tolerate an endoscopic
procedure.
- Patient refusal of the procedure.
- Acute abdominal complaint attributed to other causes.
- Coagulopathy that makes the procedure risky.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Hussein Hassan Okasha

Organization

Cairo university

Division name

faculty of medicine

Zip code

Address

350 Port Said St. Bab El Khalk, Cairo

TEL

00201001000502

Email

okasha.hussein@gmail.com

Name of contact person

1st name
Middle name
Last name	admin

Organization

faculty of medicine

Division name

research affair

Zip code

Address

Kasr Al Ainy St. Cairo, Egypt

TEL

0020223682030

Homepage URL

http://medicine.cu.edu.eg

Email

Admin@kasralainy.edu.eg

Institute

cairo univesity , faculty of medicine

Institute

Department

Personal name

Organization

cairo univesity , faculty of medicine

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2017

Year

03

Month

05

Day

Date of IRB

Anticipated trial start date

2017

Year

05

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

05

Month

01

Day

Last modified on

2017

Year

05

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031154