Submucosal Tumor of Gastrointestinal TractNCT05394129
Diagnostic Accuracy of SurePath™ in EUS-FNA
An observational study of Submucosal Tumor of Gastrointestinal Tract, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
It is a prospective randomized controlled study to evaluate the diagnostic accuracy of SurePath™ liquid-based cytology in endoscopic ultrasound-guided sampling. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Submucosal Tumor of Gastrointestinal Tract
- What is being tested?
- SurePath™
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Apr 2019to 30 Jan 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients above 19 years of age who underwent EUS-FNA for suspected esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes.
Who may be able to join
- Patients who signed the agreement after the explanation
- Patients suspected of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes from radiological(CT, MR, ultrasound) or endoscopic examinations.
Who cannot join
- Those who did not agree with the study
- Patients younger than 19 years of age
- Serious mental patients
- Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, sever mental illness)
- Pregnant women
- If EUS is difficult due to previous surgery (Billroth II or TG with R-en-Y)
- Patient with blood clotting abnormality
- If there is a risk of tract seeding after examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Comparison of SurePath™ Liquid -Based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Esophageal, Gastric, Duodenal Subepithelial Tumors, Periesophageal and Perigastric Lymph Nodes
It is a prospective randomized controlled study to evaluate the diagnostic accuracy of SurePath™ liquid-based cytology in endoscopic ultrasound-guided sampling.
Read the detailed description
The SurePath™ has been approved by the FDA since 1997. Investigators want to compare the diagnostic accuracy of SurePath™ liquid based cytology and conventional smear cytology(CSC) in EUS-FNA sampling of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes.
The investigators randomly assigned (1:1) patients to the SurePath™ group or the CSC group. Aspirates from the first needle pass were processed by one method, aspirates from the second pass by the other method, and specimens from the last pass were processed as core biopsy samples. The primary endpoint was the diagnostic efficacy of each method, with the final diagnosis as the gold standard. The aim of this study is to confirm that the SurePath™ is not inferior than the conventional smear test.
- Being tested
- SurePath™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurePath™Diagnostic test
In the liquid-based cytology, a fine-needle aspirated sample is immediately inserted into a container containing a commercially available preservative solution without a separate slide-smearing procedure and immediately after the fine-needle aspiration.
| Study group | Role | What they receive |
|---|---|---|
| SurePath™ | The subjects are randomly assigned to SurePath™/Conventional test group at a ratio of 1:1.
In SurePath™ group, subjects who underwent SurePath™ liquid-phase cytology test with the first sample subjected to the conventional smear test with the second sample. Receives: Diagnostic Test: SurePath™ | |
| Conventional | The subjects are randomly assigned to SurePath™/Conventional test group at a ratio of 1:1.
In conventional test group, those who subjected to the conventional smear test with the first sample, will undergo the SurePath™ liquid cell test with the second obtained sample. Receives: Diagnostic Test: SurePath™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Pathologic results of the surgical specimen or core needle biopsy will be checked whether it is malignancy or benign. If benign diagnosis is made by combining the results of SurePathTM and conventional smear test, the follow-up period is 6 months and the results of the 6-month follow-up imaging and additional biopsy are checked. The combined results make a final diagnosis and are compared between two groups.
Measured: 6 months after randomization
Secondary outcomes (1)
Cytomorphologic feature
The investigators will evaluate the cytomorphologic features of each method. The investigators plan to investigate whether there are differences in the level of artifacts, the degree of background cleanliness, and tumor cell characteristics such as cellularity.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start9 Apr 2019
- Primary completion31 Jan 2022
- Study completion30 Jan 2023
Why it stopped: Difficulty in recruiting research subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Submucosal Tumor of Gastrointestinal TractStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Jeong Cho, Seoul National University Hospital
- Investigators
- Han Myung Lee, M.D., Study director, Fellowship
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394129
- Sponsor's protocol ID
- 1902-076-1011
- Status last verified
- Nov 2024
- First submitted
- 13 Sep 2021
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of SurePath™ Liquid -Based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Esophageal, Gastric, Duodenal Subepithelial Tumors, Periesophageal and Perigastric Lymph Nodes
- ClinicalTrials.gov ID
- NCT05394129
- Acronym / sponsor ID
- 1902-076-1011
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting research subjects
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a prospective randomized controlled study to evaluate the diagnostic accuracy of SurePath™ liquid-based cytology in endoscopic ultrasound-guided sampling.
Detailed description
The SurePath™ has been approved by the FDA since 1997. Investigators want to compare the diagnostic accuracy of SurePath™ liquid based cytology and conventional smear cytology(CSC) in EUS-FNA sampling of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes.
The investigators randomly assigned (1:1) patients to the SurePath™ group or the CSC group. Aspirates from the first needle pass were processed by one method, aspirates from the second pass by the other method, and specimens from the last pass were processed as core biopsy samples. The primary endpoint was the diagnostic efficacy of each method, with the final diagnosis as the gold standard. The aim of this study is to confirm that the SurePath™ is not inferior than the conventional smear test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SurePath™ | – | Diagnostic Test: SurePath™The subjects are randomly assigned to SurePath™/Conventional test group at a ratio of 1:1. In SurePath™ group, subjects who underwent SurePath™ liquid-phase cytology test with the first sample subjected to the conventional smear test with the second sample. |
| Conventional | – | Diagnostic Test: SurePath™The subjects are randomly assigned to SurePath™/Conventional test group at a ratio of 1:1. In conventional test group, those who subjected to the conventional smear test with the first sample, will undergo the SurePath™ liquid cell test with the second obtained sample. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients above 19 years of age who underwent EUS-FNA for suspected esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes.
Key inclusion criteria (2 listed)
- Patients who signed the agreement after the explanation
- Patients suspected of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes from radiological(CT, MR, ultrasound) or endoscopic examinations.
Key exclusion criteria (8 listed)
- Those who did not agree with the study
- Patients younger than 19 years of age
- Serious mental patients
- Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, sever mental illness)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurePath™In the liquid-based cytology, a fine-needle aspirated sample is immediately inserted into a container containing a commercially available preservative solution without a separate slide-smearing procedure and immediately after the fine-needle aspiration. | Diagnostic test | Conventional, SurePath™ |
Primary outcome
Diagnostic accuracy
Time frame: 6 months after randomization
Pathologic results of the surgical specimen or core needle biopsy will be checked whether it is malignancy or benign. If benign diagnosis is made by combining the results of SurePathTM and conventional smear test, the follow-up period is 6 months and the results of the 6-month follow-up imaging and additional biopsy are checked. The combined results make a final diagnosis and are compared between two groups.
1 secondary outcome
Cytomorphologic feature
Time frame: 6 months after randomization
Results and safety
The study was stopped early (reason given: Difficulty in recruiting research subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Submucosal Tumor of Gastrointestinal Tract
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingObservational study
Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study
Colorectal Cancer
Recruiting
Epinephrine 1:100,000 Versus 1:500,000 During Gastric Endoscopic Submucosal Dissection
Gastric Neoplasms, Gastric Dysplasia
RecruitingObservational study
Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
Esophageal Neoplasm, Esophageal Polyp
Active, not recruiting
Clinical Application of an AI-based Dissection Trajectory Prediction System (ADTPS) in Endoscopic Submucosal Dissection
Esophageal Squamous Cell Carcinoma (ESCC), High-Grade Intraepithelial Neoplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han Myung Lee, M.D. study director
Fellowship
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Submucosal Tumor of Gastrointestinal Tract, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting research subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.