NCT02360839

Brief Summary

Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology and/or fine needle biopsy (FNB) for histology may be used in the diagnostic work-up of intrathoracic and intrabdominal lesion of unknown origin. Certain lesions (such as pancreatic adenocarcinoma) are often well characterized by cytology assessment of FNA-samples while others are not (such as GIST-tumors). This study is a part observational (early study phase) and part interventional study (late study phase) on the diagnostic accuracy of EUS-assisted tissue sampling by FNA or FNB during a 10-year period on a tertiary endoscopy centre.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

13.1 years

First QC Date

January 26, 2015

Last Update Submit

June 27, 2023

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

  • The cellular quality of the EUS-FNA specimens (categorical variable).

    Specimens are measured on a standardized 5-grade categorical scale - from 1 (=poor, non-diagnostic yield) to 5 (excellent, completely diagnostic yield). There is no specific unit measured (the variable is not a continuous one). The results from cytology assessment of EUS-derived tissue are compared to the final diagnosis, that is based on the subsequent surgery report. Results from FNA and FNB are regarded equally important. That is why both are treated as Primary Outcomes.

    Follow up is by time of surgery (in average 2 months after EUS-FNA)

  • The histological quality of the EUS-FNB specimens (categorical variable).

    Specimens are measured on a standardized 5-grade categorical scale - from 1 (=poor, non-diagnostic yield) to 5 (excellent, completely diagnostic yield). There is no specific unit measured (the variable is not a continuous one). The results from pathology assessment of EUS-derived tissue are compared to the final diagnosis, that is based on the subsequent surgery report. Results from FNA and FNB are regarded equally important. That is why both are treated as Primary Outcomes.

    Follow up is by time of surgery (in average 2 months after EUS-FNB)

Secondary Outcomes (1)

  • Immunohistochemistry profiling of EUS

    Follow up is by time of surgery (in average 2 months after EUS)

Study Arms (2)

Early

NO INTERVENTION

Study subjects (patients) undergoing endoscopic ultrasound (with or without FNA/TCB) for clinical reasons during 2005-2011.

Late

OTHER

Study subjects (patients) undergoing endoscopic ultrasound with EUS-guided sampling of various lesions for clinical reasons during 20012-2015. Subjects sampled with both EUS-FNA and EUS-FNB on the same lesion. Randomization on first needle order.

Device: EUS-guided fine needle biopsy sampling (EUS-FNB)

Interventions

EUS-guided fine needle biopsy sampling (EUS-FNB)DEVICE

Dual sampling with EUS-FNA and EUS-FNB in a randomized order.

Late

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referral for a diagnostic EUS

You may not qualify if:

  • Referral for an interventional EUS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Per Hedenström

Gothenburg, S-413 45, Sweden

Location

Related Publications (1)

  • Hedenstrom P, Demir A, Khodakaram K, Nilsson O, Sadik R. EUS-guided reverse bevel fine-needle biopsy sampling and open tip fine-needle aspiration in solid pancreatic lesions - a prospective, comparative study. Scand J Gastroenterol. 2018 Feb;53(2):231-237. doi: 10.1080/00365521.2017.1421704. Epub 2018 Jan 4.

    PMID: 29301477DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Riadh Sadik, Prof

    Sahlgrenska University Hospital, Gothenburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 11, 2015

Study Start

July 1, 2009

Primary Completion

July 31, 2022

Study Completion

December 31, 2022

Last Updated

June 28, 2023

Record last verified: 2023-06

Locations

SE(1)