Which timing—total procedure time or withdrawal time—finds more premalignant and malignant lesions during upper endoscopy
Analysis of Withdrawal Time in Upper Gastrointestinal Endoscopy as Procedure Time: a Randomised, Parallel, Double-blinded, Multicenter, International Clinical Trial
This study tests whether measuring the total inspection time or just the withdrawal time during upper endoscopy is better at finding premalignant and malignant upper gastrointestinal lesions in adults having diagnostic or surveillance endoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1290 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Portuguese Oncology Institute, Coimbra Academic / other |
| Locations | 1 site (Coimbra) |
| Trial ID | NCT06696209 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for diagnostic or surveillance upper gastrointestinal endoscopy are randomized 1:1 to have either total inspection time or withdrawal time recorded as the primary metric for the procedure. High-resolution endoscopes (with optional virtual chromoendoscopy and routine measures such as washing or simethicone at the physician's discretion) will be used and the endoscopist will timestamp key anatomical landmarks before any biopsies or therapy. Procedures proceed as clinically needed without preset minimum or maximum durations, and cases with prior upper GI surgery, known or suspected neoplasia, or planned therapeutic interventions are excluded. The recorded times and photographic documentation will be analyzed to compare which timing metric correlates with detection of premalignant and malignant lesions.
Who should consider this trial
Good fit: Adults aged 18 or older undergoing diagnostic or surveillance upper gastrointestinal endoscopy for premalignant conditions who can give informed consent and have no prior esophagus, stomach, or duodenal surgery are ideal candidates.
Not a fit: Patients with known or suspected neoplasia, those undergoing therapeutic procedures during endoscopy, or those with prior upper GI surgery are excluded and therefore will not benefit from participation in this protocol.
Why it matters
Potential benefit: If successful, this could provide clear guidance on which timing metric to use during upper endoscopy to improve early detection of premalignant and malignant lesions.
How similar studies have performed: Guidelines and several observational studies suggest longer inspection times can increase lesion detection, but randomized comparisons specifically contrasting total inspection time versus withdrawal time in upper endoscopy are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Diagnostic or surveillance upper gastrointestinal endoscopy for premalignant conditions * Informed consent for the execution of the upper gastrointestinal endoscopy and participation in the study Exclusion Criteria: * Previous esophagus, stomach, or duodenum surgery * Known or suspected neoplasia * Therapeutic procedure (polypectomy, argon plasma coagulation, hemostasis, others)
Where this trial is running
Coimbra
- Portuguese Institute of Oncology — Coimbra, Portugal (Recruiting)
Study contacts
- Study coordinator: Maria Ines Viegas, Doctor
- Email: mariainesviegas96@gmail.com
- Phone: +351911057121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.