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Evaluation of EUS-guided alcohol ablation effectiveness in treatment of insolinoma

Protocol summary

Summary
After localizing the site of the tumor by EUS, fine needle aspiration of the tumor will be performed for cytological evaluation. At least three passes of FNA with a 22-guage needle (COOK) will be taken. The samples will be placed into 70% ethanol and sent for cell block preparation and cytological evaluation. Then, a total of 6 ml of 95% ethanol will be injected during the same session using linear array echo-endoscope guidance. The patients will be hospitalized for 48 hours. The patients will be received dextrose 10% (1000 ml every 8 hours) during the first 24 hours after alcohol injection. Periodic visits of the patient will be performed during the hospitalization. The patients will be monitored for any symptoms (e.g. abdominal pain, nausea, vomiting, etc.). Serum levels of amylase and lipase will be checked at hour 12, hour 24 and hour 48 post-procedure. Outcome measures: •Fasting plasma glucose level at day 0 (before the procedure), day 1, month 1, month 3, month 6, month 12 post-procedure •EUS of the pancreas to evaluate tumor remission at month 3, and month 12 post-procedure

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201098635N2
Registration date: 2012-05-09, 1391/02/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-05-09, 1391/02/20
Registrant information
Name
Mehdi Mohammadnejad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1633
Email address
mehdim@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of EUS-guided alcohol ablation effectiveness in treatment of insolinoma
Public title
Evaluation of EUS-guided alcohol ablation effectiveness in treatment of insolinoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: •Biochemically proven solitary insulinoma •Ages between 18 and 80 years old Exclusion criteria: •Insulinoma size of 2 cm or more •Presence of lymph node, or vascular involvement of the tumor in EUS or spiral CT scan •Presence of liver or other distant metastases in the spiral CT scan •Presence of MEN-1 syndrome •Presence of multiple insulinomas •Inability to localize the tumor by EUS •Unwilling to assign inform consent
Age
From 18 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
Tehran university of medical sciences, Ghods ave, Keshavarz boulvard, Tehran
City
Tehran
Postal code
Approval date
2012-05-02, 1391/02/13
Ethics committee reference number
16322

Health conditions studied

1

Description of health condition studied
insulinoma
ICD-10 code
C25.9
ICD-10 code description
Pancreas, unspecified

Primary outcomes

1

Description
The effectivenrss of the process
Timepoint
In the first and third month after treatment, BS level, and also in the third month the size of tumor would be measured and regiter by (EUS) method.
Method of measurement
According to check list

2

Description
Serum amylase
Timepoint
12, 24 and48 hours post(EUS)
Method of measurement
Patients blood sampling

3

Description
Serum lipase
Timepoint
12, 24 and 48 hours post(EUS)
Method of measurement
Patient's blood sampling

4

Description
The procedure's time
Timepoint
During sonography and alcohol injection
Method of measurement
According to endoscopist's report

Secondary outcomes

1

Description
Complications
Timepoint
During first 48 hours of admission
Method of measurement
According to physical exams and tests

2

Description
Admission time
Timepoint
The average of the patient's spending days while the procedure untill discharging from the hospital
Method of measurement
According to the file

Intervention groups

1

Description
After localizing the site of the tumor by EUS, fine needle aspiration of the tumor will be performed for cytological evaluation. At least three passes of FNA with a 22-guage needle (COOK) will be taken. The samples will be placed into 70% ethanol and sent for cell block preparation and cytological evaluation. Then, a total of 6 ml of 95% ethanol will be injected during the same session using linear array echo-endoscope guidance. The patients will be hospitalized for 48 hours. The patients will be received dextrose 10% (1000 ml every 8 hours) during the first 24 hours after alcohol injection. Periodic visits of the patient will be performed during the hospitalization. The patients will be monitored for any symptoms (e.g. abdominal pain, nausea, vomiting, etc.). Serum levels of amylase and lipase will be checked at hour 12, hour 24 and hour 48 post-procedure. Outcome measures: •Fasting plasma glucose level at day 0 (before the procedure), day 1, month 1, month 3, month 6, month 12 post-procedure •EUS of the pancreas to evaluate tumor remission at month 3, and month 12 post-procedure
Category
Treatment - Drugs

2

Description
Control group: the patients with insulinoma treating by surgery
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Tehran University of Medical Sciences
Full name of responsible person
Ms. Malmir
Street address
class 5, Tehran University of Medical Sciences, Ghods ave, Keshavarz boulvard, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Firoozgar hospital
Full name of responsible person
Neda rabiei
Position
General physician
Other areas of specialty/work
Street address
Resaerch center of Gastroentrology and liver diseases, Firoozgar hospital, Beh afarin st, Vali asr sq.
City
Tehran
Postal code
Phone
+98 21 8214 1711
Fax
Email
Neda.rabiei@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shariati hospital
Full name of responsible person
Mehdi Mohammadnejad
Position
Specialist in gastroentrology and liver diseases
Other areas of specialty/work
Street address
Tehran, Northern Karegar st, Shariati hospital.
City
Tehran
Postal code
Phone
+98 21 8822 0000
Fax
Email
mehdi.nejad@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shariati hospital
Full name of responsible person
Mehdi Mohamadnejad
Position
Gastroenterologist
Other areas of specialty/work
Street address
Shariati hospital, North Kargar Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 8822 0000
Fax
Email
mehdi.nejad@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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