| CTRI Number |
CTRI/2014/08/004845 [Registered on: 08/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
14/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study of a Randomized Evaluation of Pancreatic Cystic Lesions Using Three EUS-FNA Needles |
|
Scientific Title of Study
|
A Multicenter, Prospective, Randomized Study on Endosonographic Evaluation of Pancreatic Cystic Lesions Using 22 G, 19 G, and Flexible 19 G Fine Needle Aspiration |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| E7084, Version AF, 11/Jun/2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Lakhtakia |
| Designation |
MD |
| Affiliation |
Asian Institute of Gastroenterology |
| Address |
Asian Institute of Gastroenterology
6-3-661 Somajiguda
Hyderabad, India
Gastroenterology
6-3-661 Somajiguda
Hyderabad, India
Hyderabad
ANDHRA PRADESH
500 082
India |
| Phone |
914023378888 |
| Fax |
|
| Email |
drsundeeplakhtakia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sundeep Lakhtakia |
| Designation |
Principal Investigator |
| Affiliation |
Asian Institute of Gastroenterology |
| Address |
Asian Institute of Gastroenterology
6-3-661 Somajiguda,
Hyderabad
India
6-3-661 Somajiguda,
Hyderabad
India
Hyderabad
ANDHRA PRADESH
500 082
India |
| Phone |
|
| Fax |
|
| Email |
drsundeeplakhtakia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sundeep Lakhtakia |
| Designation |
Principal Investigator |
| Affiliation |
Asian Institute of Gastroenterology |
| Address |
Asian Institute of Gastroenterology
6-3-661 Somajiguda,
Hyderabad
India
6-3-661 Somajiguda,
Hyderabad
India
Hyderabad
ANDHRA PRADESH
500 082
India |
| Phone |
|
| Fax |
|
| Email |
drsundeeplakhtakia@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Boston Scientific |
| Address |
100 Boston Scientific Way
Marlborough, MA
01752
USA |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sandeep Lakhtakia |
Asian Institute of Gastroenterology |
6-3-661 Somajiguda,
Hyderabad,India
500 082
Hyderabad
ANDHRA PRADESH |
914023378888
drsundeeplakhtakia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Asian Institute of Gastroenterology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pancreatic Cystic Lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
19 G Flex Needle |
Fine Needle Aspiration of PCL with a 19 G Flex needle. If unsuccessful, a salvage procedure will be done with 19 G or 22 G needle. |
| Intervention |
19 G Needle |
Fine Needle Aspiration of PCL with a 19 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle. |
| Intervention |
22 G Needle |
Fine Needle Aspiration of PCL with a 22 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Pancreatic cystic lesion measuring 13mm or greater in largest diameter.
Indicated for EUS evaluation of the PCL including EUS FNA.
Age 18 years of age or older.
Willing and able to comply with the study procedures and provide written informed consent form to participate in the study. |
|
| ExclusionCriteria |
| Details |
Cysts in which FNA is not indicated based on review by the clinician, including potential concern of blood vessel location relative to cyst.
Requirement for anticoagulation using clopidogril, warfarin, or other long acting antiplatelet agents (with the exception of aspirin) that cannot be safely stopped according to institutional guidelines
Standard contraindications for EUS.
Known pancreatic pseudocyst.
Pregnancy. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Volume of aspirated cyst fluid as a function of estimated maximal volume based on pre-aspiration EUS measure of cyst diameter (s) (% aspiration of total estimated volume) |
At Procedure (Up to 1 hour) |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Occurrence, severity and relatedness of adverse events to the needle and procedure. |
30 days |
| Extent of cyst aspiration as measured by reduction of maximal cyst diameter before and after FNA (converted to volume by standard geometric formulation). |
Procedure (Up to 1 hour) |
| Successful echoendoscopic fine needle aspiration of PCL, defined as complete cyst aspiration or collection of aspirate adequate to perform two standard assays: cytology and carcinoembryonic antigen (CEA) |
At procedure |
| Ability to reach and penetrate the PCL, stratified by route of access and PCL location. |
Procedure (Up to 1 hour) |
| Number of EUS-FNA needles and EUS-FNA needle passes used. |
Procedure (Up to 1 hour) |
| Time needed for aspiration for each pass and time from first needle pass in to last needle pass out. |
Procedure (Up to 1 hour) |
| Ease of needle passage in and out of echoendoscope and quality of needle visualization inside the cyst, categorized as Excellent, Very Good, Good, Fair, and Poor |
Procedure (Up to 1 hour) |
| Accuracy of two EUS-FNA-based standard assays (cytology and CEA) as a diagnostic measure of disease state categorized as one of the following: serous cyst, mucinous cyst, intra papillary mucinous neoplasm (IPMN), or pseudocyst. |
30 days |
| Post EUS-FNA patient management plan (clinical and/or imaging surveillance, percutaneous aspiration, surgical removal). |
30 days |
| Impact of EUS-FNA based assays on diagnosis to determine type of cyst |
Procedure - 30 days after procedure |
| Rate of cross-over to salvage arm |
Procedure (Immediate) |
|
Target Sample Size
Modification(s)
|
Total Sample Size="250"
Sample Size from India="47"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/10/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/01/2013 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To document impact of EUS-FNA needle gauge and flexibility on effectiveness of pancreatic cystic lesions (PCL) aspiration, on ability to obtain sufficient material for standard diagnostic testing, and on diagnostic accuracy of EUS-FNA aspirate for differentiation of mucinous (pre-malignant) and non-mucinous cysts.
The hypothesis is that the EUS-FNA 19 G Flex needle will be superior to the EUS-FNA 22 G standard and 19 G standard needles for successful EUS-FNA procedures to assess PCLs. |