Premalignant ConditionsNCT06696209
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
A study testing Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy, Analysis of the total time of the Upper Gastrointestinal Endoscopy and Upper gastrointestinal endoscopy: Common Practices in people with Premalignant Conditions and Malignant Lesions, run by Portuguese Oncology Institute, Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Premalignant Conditions, Malignant Lesions, Gastric
- What is being tested?
- Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy, Analysis of the total time of the Upper Gastrointestinal Endoscopy and Upper gastrointestinal endoscopy: Common Practices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,290 participants
- Where
- 1 sitePortugal
- Study dates
- 7 Mar 2025to 31 Jul 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous esophagus, stomach, or duodenum surgery
- Known or suspected neoplasia
- Therapeutic procedure (polypectomy, argon plasma coagulation, hemostasis, others)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Withdrawal Time in Upper Gastrointestinal Endoscopy as Procedure Time: a Randomised, Parallel, Double-blinded, Multicenter, International Clinical Trial
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.
Read more
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.
Read the detailed description
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:
- First esophageal image;
- First image of the second portion of the duodenum;
- Last esophageal image.
The endoscopist will perform the UGE for as long as clinically necessary, which may be shortened if there is any need to interrupt the procedure for any clinical reason (such as intolerance or other), without any minimum or maximum time limits.
Although this is a non-interventional study that does not involve any modification to daily clinical practice, regarding the analyzed UGE, the study will be submitted for evaluation by the Ethics Committee of the Portuguese Institute of Oncology of Coimbra and will be performed in accordance with the principles of the Helsinki Declaration. All analyzed data will be kept confidential, and the investigators will ensure the anonymity of the patients included during data analysis and publication.
This study aims to define the best metric for quantifying the most appropriate time for performing a diagnostic or surveillance UGE. To our knowledge, all existing studies on the topic of procedure time in UGE are observational. This study will be the first randomised clinical trial in this area, with the purpose of providing a systematic evaluation that will contribute to the optimization of quality measures.
- Conditions
- Premalignant Conditions, Malignant Lesions, Gastric, Esophageal, Duodenal
- Being tested
- Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy, Analysis of the total time of the Upper Gastrointestinal Endoscopy, Upper gastrointestinal endoscopy: Common Practices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of the withdrawal time of the Upper Gastrointestinal EndoscopyOther
Time of last esophageal image - time of first image of the second portion of the duodenum.
Analysis of the total time of the Upper Gastrointestinal EndoscopyOther
Time of last esophageal image - time of first esophageal image
Upper gastrointestinal endoscopy: Common PracticesOther
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:
- First esophageal image;
- First image of the second portion of the duodenum;
- Last esophageal image.
| Study group | Role | What they receive |
|---|---|---|
| Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy | Active comparator | Not described Receives: 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 | Not described Receives: Other: Analysis of the total time of the Upper Gastrointestinal Endoscopy; Other: Upper gastrointestinal endoscopy: Common Practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: One month
Secondary outcomes (1)
• Complications: related to sedation, cardiopulmonary adverse events, bleeding, perforation, others.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start7 Mar 2025
- Primary completion30 Jun 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premalignant ConditionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portuguese Oncology Institute, Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Inês Viegas, Portuguese Oncology Institute, Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696209
- Sponsor's protocol ID
- PortugueseOIC 006
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Withdrawal Time in Upper Gastrointestinal Endoscopy as Procedure Time: a Randomised, Parallel, Double-blinded, Multicenter, International Clinical Trial
- ClinicalTrials.gov ID
- NCT06696209
- Acronym / sponsor ID
- PortugueseOIC 006
- Conditions
- Premalignant Conditions, Malignant Lesions, Gastric, Esophageal, Duodenal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,290 participants (actual)
- Lead sponsor
- Portuguese Oncology Institute, CoimbraUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 20 Nov 2024 (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.
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.
Detailed description
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:
- First esophageal image;
- First image of the second portion of the duodenum;
- Last esophageal image.
The endoscopist will perform the UGE for as long as clinically necessary, which may be shortened if there is any need to interrupt the procedure for any clinical reason (such as intolerance or other), without any minimum or maximum time limits.
Although this is a non-interventional study that does not involve any modification to daily clinical practice, regarding the analyzed UGE, the study will be submitted for evaluation by the Ethics Committee of the Portuguese Institute of Oncology of Coimbra and will be performed in accordance with the principles of the Helsinki Declaration. All analyzed data will be kept confidential, and the investigators will ensure the anonymity of the patients included during data analysis and publication.
This study aims to define the best metric for quantifying the most appropriate time for performing a diagnostic or surveillance UGE. To our knowledge, all existing studies on the topic of procedure time in UGE are observational. This study will be the first randomised clinical trial in this area, with the purpose of providing a systematic evaluation that will contribute to the optimization of quality measures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Previous esophagus, stomach, or duodenum surgery
- Known or suspected neoplasia
- Therapeutic procedure (polypectomy, argon plasma coagulation, hemostasis, others)
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 |
|---|---|---|
| Analysis of the withdrawal time of the Upper Gastrointestinal EndoscopyTime of last esophageal image - time of first image of the second portion of the duodenum. | Other | Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy |
| Analysis of the total time of the Upper Gastrointestinal EndoscopyTime of last esophageal image - time of first esophageal image | Other | Analysis of the total time of the Upper Gastrointestinal Endoscopy |
| Upper gastrointestinal endoscopy: Common PracticesExecution 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. | Other | Analysis of the total time of the Upper Gastrointestinal Endoscopy, Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy |
Primary outcome
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)
Time frame: One month
1 secondary outcome
• Complications: related to sedation, cardiopulmonary adverse events, bleeding, perforation, others.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of the withdrawal time of the Upper Gastrointestinal Endoscopy, Analysis of the total time of the Upper Gastrointestinal Endoscopy and Upper gastrointestinal endoscopy: Common Practices in people with Premalignant Conditions and Malignant Lesions, run by Portuguese Oncology Institute, Coimbra at 1 site in Portugal.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Nov 2026. 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 Portugal. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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) (time frame: One month). 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 3 Nov 2026.