To Evaluate the Best Metric for Inspection Time During a Diagnostic and/or Surveillance Upper Gastrointestinal Endoscopy (Age ≥ 18 Years, Informed Consent), Between Total Inspection Time Versus Withdrawal Time, for the Identification of Malignant Lesions

NCT06696209 | Recruiting

• 1 other identifier: PortugueseOIC 006
• Study Type: interventional
• Target: 1,290
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer is the fifth cause of cancer-related mortality worldwide. Gastric carcinogenesis involves the progression from premalignant conditions such as atrophic gastritis and intestinal metaplasia to premalignant lesions like dysplasia, and ultimately carcinoma. Most diagnoses of gastric cancer are made at advanced stages, with a five-year relative survival rate of 36%. Therefore, early detection of premalignant conditions and lesions is crucial, as it allows for timely surveillance and treatment, which can improve patient survival. Upper gastrointestinal endoscopy (UGE) is the first-line examination for diagnosing upper gastrointestinal tract pathology, particularly oncological conditions. The European Society of Gastrointestinal Endoscopy (ESGE) and the United European Gastroenterology (UEG) have established that UGE quality is a priority, identifying specific quality parameters, such as the duration of the procedure, which is the most extensively studied parameter. According to ESGE recommendations, all UGE reports should include the procedure time (goal: ≥90% of reports), which should be seven minutes or longer for surveillance of intestinal metaplasia. This time threshold follows a study that established a causal relationship between longer procedures (≥ seven minutes) and a higher detection rate of premalignant gastric conditions and lesions. Subsequent observational studies have generally shown that setting a minimum procedure time increases the detection rate of lesions. The definition of procedure time varies between studies, being described as the time from intubation to extubation, but also as the time for withdrawing the endoscope from the second portion of the duodenum (D2) to extubation, also known as withdrawal time. The hypothesis under study is that a better definition of the most appropriate time for a diagnostic UGE could standardize reports, improve malignant lesion detection rates, and reduce the rate of undiagnosed cancers, without any additional risk to patients. Existing studies have been retrospective or comparative between different temporal cohorts, with no prospective or randomised comparative studies, nor any studies comparing the two existing metrics. Therefore, the aim of this study is to evaluate the best metric for inspection time during a diagnostic and/or surveillance UGE, between total inspection time versus withdrawal time, for the identification of malignant lesions.

Conditions

Premalignant Conditions; Malignant Lesions; Gastric; Esophageal; Duodenal

Outcome Measures

Primary Outcomes (1)

• Primary outcome: Detection rate of premalignant conditions and malignant lesions, defined as the total number of lesions in the esophagus, stomach, or duodenum detected per randomisation group, confirmed by histological evaluation (if necessary)

  One month

Secondary Outcomes (1)

• • Complications: related to sedation, cardiopulmonary adverse events, bleeding, perforation, others.

  1 month

Study Arms (2)

Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy

ACTIVE COMPARATOR

Other: Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy; Other: Upper gastrointestinal endoscopy: Common Practices

Analysis of the total time of the Upper Gastrointestinal Endoscopy

ACTIVE COMPARATOR

Other: Analysis of the total time of the Upper Gastrointestinal Endoscopy; Other: Upper gastrointestinal endoscopy: Common Practices

Interventions

Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy OTHER

Time of last esophageal image - time of first image of the second portion of the duodenum.

Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy

Analysis of the total time of the Upper Gastrointestinal Endoscopy OTHER

Time of last esophageal image - time of first esophageal image

Analysis of the total time of the Upper Gastrointestinal Endoscopy

Upper gastrointestinal endoscopy: Common Practices OTHER

Execution of UGE using high-resolution endoscopes, with the option of virtual chromoendoscopy, according with the physician's preference. Possible optimization of visualization with washing and/or the use of simethicone or similar, as pre-medication or during the examination, according with the physician's preference. Patients will be randomised to one of the following measurements-total time versus withdrawal time-in a parallel 1:1 scheme. The allocation of the randomisation group will be computer-generated. The endoscopist must record the time at which the following three anatomical structures are reached (either by noting during the procedure or based on the information in the photographic documentation), before any biopsies or therapeutic interventions, in the format xxh:xxmin:xxsec: 1. First esophageal image; 2. First image of the second portion of the duodenum; 3. Last esophageal image.

Analysis of the total time of the Upper Gastrointestinal Endoscopy; Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous esophagus, stomach, or duodenum surgery
• Known or suspected neoplasia
• Therapeutic procedure (polypectomy, argon plasma coagulation, hemostasis, others)

Sponsors & Collaborators

• Portuguese Oncology Institute, Coimbra: lead

Study Sites (1)

Portuguese Institute of Oncology

Coimbra, 3030-508, Portugal

RECRUITING

Central Study Contacts

Maria Ines Viegas, Doctor

CONTACT

+351911057121; mariainesviegas96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 20, 2024
• Study Start: March 7, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

PT (1)