To Study the Role of Liquid Based Cytology (LBC) for Diagnosis and Characterization of Biliopancreatic Tumor s Compared With Standard Cytology and On-site Evaluation.

Sponsor
Institute of Liver and Biliary Sciences, India (Other)
Overall Status
Unknown status
CT.gov ID
NCT04022408
Collaborator
(none)
60
1
2
15.8
3.8

Study Details

Study Description

Brief Summary

Liquid Based Cytology is a method of preparing samples for examination in cytopathology.Liquid-based cytology (LBC), enables cells to be suspended in a monolayer. LBC makes better cytological assessment possible with improved sensitivity and specificity, since fixation is better and nuclear details are well preserved in the technique. Conventional cytology is gold standard for biliopancreatic malignancy examination. This method is operator depended and have high inter observer variation . On site evaluation increases the sensitivity of conventional cytology but requires the presence of pathologist at the time of sampling . Our study will compare LBC with conventional cytology ,If found to be non inferior will be great help in centre were on site evaluation cannot be carried out . It will further reduce the interobserver variation

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Liquid based cytology
  • Diagnostic Test: Conventional cytology
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
"To Study the Role of Liquid Based Cytology (LBC) for Diagnosis and Characterization of Biliopancreatic Tumor s Compared With Standard Cytology and On-site Evaluation: A Non-inferiority Trail".
Actual Study Start Date :
Jul 8, 2019
Anticipated Primary Completion Date :
Oct 31, 2020
Anticipated Study Completion Date :
Oct 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Liquid based cytology

.Liquid-based cytology (LBC), enables cells to be suspended in a monolayer. LBC makes better cytological assessment possible with improved sensitivity and specificity, since fixation is better and nuclear details are well preserved in the technique. Preneoplasticand neoplastic cells are not obscured by other cells, such as normal epithelial and inflammatory cells. LBC techniques are currently applied to cytological samples from several tissues or fluids. They include uterine cervix , endometrium, aspirates from breast , thyroid tumors, ascites and pleural effusion, and urine , LBC technology is suggested as an appropriate diagnostic method for metastatic tumors in cerebrospinal fluid .

Diagnostic Test: Liquid based cytology
Liquid based cytology

Active Comparator: Conventional cytology

It is a gold standard for histopathological diagnosis of pancreatobiliary malignancies till date

Diagnostic Test: Conventional cytology
Conventional cytology

Outcome Measures

Primary Outcome Measures

  1. Sensitivity of LBC for diagnosis of Bilio-pancreatic tumors, compared to cytology, on-site evaluation, and cell-block preparation. [0 day]

Secondary Outcome Measures

  1. Comparison of liquid based cytology versus conventional cytology in the diagnosis of tumor with size < 2 cm or > 2 cm [0 day]

  2. Comparison of liquid based cytology versus conventional cytology in the diagnosis of tumor with respect to site of tumor (pancreas biliary tract or gall bladder). [0 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Consenting patients (or guardian) undergoing EUS guided sampling of suspected pancreato-biliary tumors
Exclusion Criteria:
  • Patients on anti-platelet agents(including aspirin).

  • Patients with deranged coagulation parameters, defined by platelet counts <75,000/mm3 and/or INR >1.8

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Liver & Biliary Sciences New Delhi Delhi India 110070

Sponsors and Collaborators

  • Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT04022408
Other Study ID Numbers:
  • ILBS-Biliopancreatic Tumor-01
First Posted:
Jul 17, 2019
Last Update Posted:
Apr 8, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 8, 2020