Colorectal PolypsPRINCESSNCT07874152
White Light, TXI, NBI and Computer-Aided Detection for Recurrence at Post-EMR Scars (PRINCESS)
A study testing High-definition white light endoscopy (WLE), Texture and color enhancement imaging (TXI) and Narrow-band imaging (NBI) in people with Colorectal Polyps, run by University Hospital Virgen de las Nieves at 2 sites in Spain.
Trial summary
Large colorectal polyps removed piece by piece (piecemeal endoscopic mucosal resection) can recur at the resection scar. Detecting this residual or recurrent tissue at surveillance colonoscopy is essential, because it can then be treated endoscopically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- High-definition white light endoscopy (WLE), Texture and color enhancement imaging (TXI) and Narrow-band imaging (NBI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Dec 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Previous endoscopic resection (endoscopic mucosal resection or endoscopic submucosal dissection) of a colorectal lesion ≥15 mm, performed 3 to 6 months before the surveillance colonoscopy.
- Histology of the resected lesion showing an adenoma or a sessile serrated lesion.
- Referral for endoscopic review of the post-polypectomy scar.
- Signed written informed consent.
Who cannot join
- Resected lesion <15 mm.
- Histology of the resected lesion other than adenoma or sessile serrated lesion.
- Incomplete previous resection, or uncertainty about the completeness of the previous resection.
- Patients who, because of age or comorbidity, are not candidates for endoscopic surveillance.
- Failure to complete the study protocol, including biopsy of the scar.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Department of Gastroenterology and Hepatology. Virgen de las Nieves University Hospitals
Granada, Granada, 18014
Eduardo Cerezo, MD, PhD, +34 657373336, eredondoc@gmail.com
Juan G Martinez-Cara, MD, +34 630863340, juangadoctor@gmail.com
- Recruiting
Virgen de las Nieves University Hospital. Department of Gastroenterology and Hepatology
Granada, Granada, 18014
Eduardo Redondo-Cerezo, MD, PhD, +34 657373336, eredondoc@gmail.com
About this study
Official title: Diagnostic Accuracy of White Light Endoscopy, Texture and Color Enhancement Imaging (TXI), Narrow-Band Imaging (NBI) and Artificial Intelligence (GI Genius) for the Detection of Adenomatous Recurrence at Post-Polypectomy Scars: a Prospective, Randomized Crossover, Blinded Study (PRINCESS)
Large colorectal polyps removed piece by piece (piecemeal endoscopic mucosal resection) can recur at the resection scar. Detecting this residual or recurrent tissue at surveillance colonoscopy is essential, because it can then be treated endoscopically. Recurrence can be subtle, and the best way to examine the scar has not been established.
This study compares four ways of examining post-polypectomy scars:
Read more
high-definition white light endoscopy (WLE) texture and color enhancement imaging (TXI, Olympus) narrow-band imaging (NBI, Olympus) an artificial intelligence computer-aided detection system (GI Genius, Medtronic)
Each scar is examined with all four techniques, in random order. A different expert endoscopist performs each technique, without knowing the findings of the others. Biopsies are then taken from every scar, and any suspicious tissue is removed. Histology is the reference standard.
The main goal is to determine which technique, or combination of techniques, has the highest sensitivity and negative predictive value for detecting recurrence.
Read the detailed description
Background. Local recurrence after piecemeal endoscopic mucosal resection (EMR) of large non-pedunculated colorectal lesions occurs in about 15-20% of cases, and most recurrences appear within the first 6 months. Guidelines recommend a first surveillance colonoscopy 3 to 6 months after piecemeal resection and a second at 12 months. Virtual chromoendoscopy improves the detection of recurrence compared with white light, and some guidelines suggest that routine scar biopsy may be omitted when advanced imaging is used. However, newer image-enhancement modes such as TXI, and computer-aided detection (CADe) systems trained on native polyps, have not been evaluated for post-EMR scars. No study has compared these techniques with each other.
Objectives. The main objective is to identify the best method for examining post-polypectomy scars. The specific objectives are to compare the detection of residual or recurrent neoplasia between:
WLE and TXI WLE and GI Genius TXI and GI Genius NBI and each of the other modalities.
Design. Prospective, single-center, randomized crossover diagnostic accuracy study with blinded assessors, conducted at the Endoscopy Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Population. Adults (>18 years) referred for scar review 3 to 6 months after EMR or endoscopic submucosal dissection of a colorectal lesion ≥15 mm whose histology showed an adenoma or sessile serrated lesion. Exclusion criteria are other index lesion histology, incomplete or uncertain previous resection, and age or comorbidity precluding endoscopic surveillance. Patients with more than one scar contribute each scar separately.
Procedure.
A first expert endoscopist advances the colonoscope to the cecum with white light.
The patient is then randomized to the modality used first. The endoscopist locates the scar, records whether recurrence is present and its estimated size, takes at least 5 photographs, and leaves the colonoscope 5-10 cm proximal to the scar.
A second expert endoscopist then enters the room and assesses the scar with another modality, followed by further endoscopists for the remaining ones. Which endoscopist performs each modality is assigned at random for every case.
Each assessor is unaware of the previous findings. Nursing staff record each diagnosis on a case report form, which the endoscopists cannot consult until the end of the procedure.
Finally, 2-4 biopsies are taken from every scar, and any tissue considered residual by at least one endoscopist is resected and sent separately.
All participating endoscopists are experts, with more than 10,000 colonoscopies and more than 500 in the previous year. Specimens are assessed by expert gastrointestinal pathologists.
Recurrence is defined according to Higaki criteria: any neoplastic tissue arising within or less than 5 mm from the margins of the scar. Patients underwent a further examination at 12 months using the same protocol.
Outcomes.
Primary: sensitivity and negative predictive value of each modality for histologically confirmed recurrence.
Secondary: specificity, positive predictive value, likelihood ratios, and the sensitivity and negative predictive value of combinations of modalities (WLE+TXI, WLE+GI Genius, TXI+NBI).
Other: endoscopic characterization of recurrence (NICE classification and WASP criteria) and recurrence at the 12-month examination.
Statistical analysis. Diagnostic accuracy measures are reported with 95% confidence intervals (Wilson method). Because all modalities are applied to the same scars, comparisons are paired. The planned sample size is 205 scars, with an interim analysis after 165 scars.
Ethics. The study was approved by the Research Ethics Committee of Granada (CEIm de Granada) [SICEIA-2024-002527]. All participants gave written informed consent. Data are pseudonymized in accordance with Spanish Organic Law 3/2018 on data protection.
- Conditions
- Colorectal Polyps
- Being tested
- High-definition white light endoscopy (WLE), Texture and color enhancement imaging (TXI), Narrow-band imaging (NBI), GI Genius (CADe)
- Keywords
- Colorrectal polyps recurrence, Polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition white light endoscopy (WLE)Diagnostic test
Standard high-definition white light assessment of the post-polypectomy scar (EVIS X1, Olympus).
Texture and color enhancement imaging (TXI)Device
Image-enhancement mode of the EVIS X1 platform (Olympus) enhancing texture, brightness and color.
Narrow-band imaging (NBI)Device
Virtual chromoendoscopy mode of the EVIS X1 platform (Olympus). Added by protocol amendment.
GI Genius (CADe)Device
Artificial intelligence computer-aided detection system (Medtronic) used during white light assessment of the scar.
| Study group | Role | What they receive |
|---|---|---|
| WLE first | Experimental | Scar assessed first with high-definition white light, then with the remaining modalities by different blinded endoscopists. All scars biopsied. Receives: Diagnostic Test: High-definition white light endoscopy (WLE) |
| TXI First | Experimental | Scar assessed first with TXI, then with the remaining modalities by different blinded endoscopists. All scars biopsied. Receives: Device: Texture and color enhancement imaging (TXI) |
| GI genius First | Experimental | Scar assessed first with GI Genius CADe, then with the remaining modalities by different blinded endoscopists. All scars biopsied. Receives: Device: GI Genius (CADe) |
| NBI First | Experimental | Scar assessed first with Narrow Band Imaging (NBI), then with the remaining modalities by different blinded endoscopists. All scars biopsied. Receives: Device: Narrow-band imaging (NBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for histologically confirmed recurrence at the post-polypectomy scar
Proportion of scars with histologically confirmed recurrence that are correctly identified as recurrence by each modality (WLE, TXI, NBI, GI Genius). Recurrence is defined by Higaki criteria (neoplastic tissue within or <5 mm from the scar margins). Reference standard: histology of scar biopsies and resected tissue.
Measured: At the surveillance colonoscopy, 3 to 6 months after resection
Negative predictive value for histologically confirmed recurrence
Proportion of scars classified as free of recurrence by each modality that show no recurrence on histology.
Measured: At the surveillance colonoscopy, 3 to 6 months after resection
Secondary outcomes (4)
Specificity and positive predictive value of each modality
Specificity and PPV of WLE, TXI, NBI and GI Genius for recurrence, against histology.
Measured: 3 to 6 months after resection
Sensitivity and negative predictive value of combined modalities
Sensitivity and NPV of WLE+TXI, WLE+GI Genius and TXI+NBI. A combination is positive if either modality is positive.
Measured: 3 to 6 months after resection
Diagnostic accuracy at the 12-month surveillance colonoscopy
Sensitivity and NPV of each modality for late recurrence, against histology.
Measured: 12 months after the first surveillance colonoscopy
Endoscopic characterization of recurrence
Agreement of the NICE classification and the WASP criteria with the histological type of recurrence.
Measured: 3 to 6 months and 12 months after resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Dec 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypsStudies 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
- Crossover
- Model description
- Every patient will have his/her scar studied by the endoscopic light modalities included in the study.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Virgen de las Nieves
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EDUARDO REDONDO CEREZO, MD, PhD, University Hospital Virgen de las Nieves
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874152
- Sponsor's protocol ID
- PRINCESS.HUVN.24
- Acronym
- PRINCESS
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to Share IPD: Yes IPD Sharing Plan Description: De-identified individual participant data underlying the results reported in the publications (diagnostic findings of each modality, histology and baseline characteristics) will be shared upon reasonable request to the principal investigator, after approval of a methodologically sound proposal and signature of a data sharing agreement. Sharing will comply with the General Data Protection Regulation and Spanish Organic Law 3/2018 and may require approval by the Research Ethics Committee of Granada.
Publications
Higaki S, Hashimoto S, Harada K, Nohara H, Saito Y, Gondo T, Okita K. Long-term follow-up of large flat colorectal tumors resected endoscopically. Endoscopy. 2003 Oct;35(10):845-9. doi: 10.1055/s-2003-42622.
PubMed 14551863Repici A, Badalamenti M, Maselli R, Correale L, Radaelli F, Rondonotti E, Ferrara E, Spadaccini M, Alkandari A, Fugazza A, Anderloni A, Galtieri PA, Pellegatta G, Carrara S, Di Leo M, Craviotto V, Lamonaca L, Lorenzetti R, Andrealli A, Antonelli G, Wallace M, Sharma P, Rosch T, Hassan C. Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial. Gastroenterology. 2020 Aug;159(2):512-520.e7. doi: 10.1053/j.gastro.2020.04.062. Epub 2020 May 1.
PubMed 32371116Ortiz O, Daca-Alvarez M, Rivero-Sanchez L, Saez De Gordoa K, Moreira R, Cuatrecasas M, Balaguer F, Pellise M. Linked-color imaging versus high definition white-light endoscopy for evaluation of post-polypectomy scars of nonpedunculated lesions: LCI-Scar study. Endoscopy. 2024 Apr;56(4):283-290. doi: 10.1055/a-2204-3236. Epub 2023 Nov 6.
PubMed 37931908Kandel P, Brand EC, Pelt J, Ball CT, Chen WC, Bouras EP, Gomez V, Raimondo M, Woodward TA, Wallace MB; EMR SCAR Group. Endoscopic scar assessment after colorectal endoscopic mucosal resection scars: when is biopsy necessary (EMR Scar Assessment Project for Endoscope (ESCAPE) trial). Gut. 2019 Sep;68(9):1633-1641. doi: 10.1136/gutjnl-2018-316574. Epub 2019 Jan 11.
PubMed 30635409Desomer L, Tutticci N, Tate DJ, Williams SJ, McLeod D, Bourke MJ. A standardized imaging protocol is accurate in detecting recurrence after EMR. Gastrointest Endosc. 2017 Mar;85(3):518-526. doi: 10.1016/j.gie.2016.06.031. Epub 2016 Jun 22.
PubMed 27343411Hassan C, Antonelli G, Dumonceau JM, Regula J, Bretthauer M, Chaussade S, Dekker E, Ferlitsch M, Gimeno-Garcia A, Jover R, Kalager M, Pellise M, Pox C, Ricciardiello L, Rutter M, Helsingen LM, Bleijenberg A, Senore C, van Hooft JE, Dinis-Ribeiro M, Quintero E. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 Aug;52(8):687-700. doi: 10.1055/a-1185-3109. Epub 2020 Jun 22.
PubMed 32572858Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.
PubMed 24671869
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of White Light Endoscopy, Texture and Color Enhancement Imaging (TXI), Narrow-Band Imaging (NBI) and Artificial Intelligence (GI Genius) for the Detection of Adenomatous Recurrence at Post-Polypectomy Scars: a Prospective, Randomized Crossover, Blinded Study (PRINCESS)
- ClinicalTrials.gov ID
- NCT07874152
- Acronym / sponsor ID
- PRINCESS / PRINCESS.HUVN.24
- Conditions
- Colorectal Polyps
- Keywords
- Colorrectal polyps recurrence, Polypectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- University Hospital Virgen de las NievesUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Oct 2026 (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.
Large colorectal polyps removed piece by piece (piecemeal endoscopic mucosal resection) can recur at the resection scar. Detecting this residual or recurrent tissue at surveillance colonoscopy is essential, because it can then be treated endoscopically. Recurrence can be subtle, and the best way to examine the scar has not been established.
This study compares four ways of examining post-polypectomy scars:
high-definition white light endoscopy (WLE) texture and color enhancement imaging (TXI, Olympus) narrow-band imaging (NBI, Olympus) an artificial intelligence computer-aided detection system (GI Genius, Medtronic)
Each scar is examined with all four techniques, in random order. A different expert endoscopist performs each technique, without knowing the findings of the others. Biopsies are then taken from every scar, and any suspicious tissue is removed. Histology is the reference standard.
The main goal is to determine which technique, or combination of techniques, has the highest sensitivity and negative predictive value for detecting recurrence.
Detailed description
Background. Local recurrence after piecemeal endoscopic mucosal resection (EMR) of large non-pedunculated colorectal lesions occurs in about 15-20% of cases, and most recurrences appear within the first 6 months. Guidelines recommend a first surveillance colonoscopy 3 to 6 months after piecemeal resection and a second at 12 months. Virtual chromoendoscopy improves the detection of recurrence compared with white light, and some guidelines suggest that routine scar biopsy may be omitted when advanced imaging is used. However, newer image-enhancement modes such as TXI, and computer-aided detection (CADe) systems trained on native polyps, have not been evaluated for post-EMR scars. No study has compared these techniques with each other.
Objectives. The main objective is to identify the best method for examining post-polypectomy scars. The specific objectives are to compare the detection of residual or recurrent neoplasia between:
WLE and TXI WLE and GI Genius TXI and GI Genius NBI and each of the other modalities.
Design. Prospective, single-center, randomized crossover diagnostic accuracy study with blinded assessors, conducted at the Endoscopy Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Population. Adults (>18 years) referred for scar review 3 to 6 months after EMR or endoscopic submucosal dissection of a colorectal lesion ≥15 mm whose histology showed an adenoma or sessile serrated lesion. Exclusion criteria are other index lesion histology, incomplete or uncertain previous resection, and age or comorbidity precluding endoscopic surveillance. Patients with more than one scar contribute each scar separately.
Procedure.
A first expert endoscopist advances the colonoscope to the cecum with white light.
The patient is then randomized to the modality used first. The endoscopist locates the scar, records whether recurrence is present and its estimated size, takes at least 5 photographs, and leaves the colonoscope 5-10 cm proximal to the scar.
A second expert endoscopist then enters the room and assesses the scar with another modality, followed by further endoscopists for the remaining ones. Which endoscopist performs each modality is assigned at random for every case.
Each assessor is unaware of the previous findings. Nursing staff record each diagnosis on a case report form, which the endoscopists cannot consult until the end of the procedure.
Finally, 2-4 biopsies are taken from every scar, and any tissue considered residual by at least one endoscopist is resected and sent separately.
All participating endoscopists are experts, with more than 10,000 colonoscopies and more than 500 in the previous year. Specimens are assessed by expert gastrointestinal pathologists.
Recurrence is defined according to Higaki criteria: any neoplastic tissue arising within or less than 5 mm from the margins of the scar. Patients underwent a further examination at 12 months using the same protocol.
Outcomes.
Primary: sensitivity and negative predictive value of each modality for histologically confirmed recurrence.
Secondary: specificity, positive predictive value, likelihood ratios, and the sensitivity and negative predictive value of combinations of modalities (WLE+TXI, WLE+GI Genius, TXI+NBI).
Other: endoscopic characterization of recurrence (NICE classification and WASP criteria) and recurrence at the 12-month examination.
Statistical analysis. Diagnostic accuracy measures are reported with 95% confidence intervals (Wilson method). Because all modalities are applied to the same scars, comparisons are paired. The planned sample size is 205 scars, with an interim analysis after 165 scars.
Ethics. The study was approved by the Research Ethics Committee of Granada (CEIm de Granada) [SICEIA-2024-002527]. All participants gave written informed consent. Data are pseudonymized in accordance with Spanish Organic Law 3/2018 on data protection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
- Model description
- Every patient will have his/her scar studied by the endoscopic light modalities included in the study.
| Arm | Type | Receives |
|---|---|---|
| WLE first | Experimental | Diagnostic Test: High-definition white light endoscopy (WLE)Scar assessed first with high-definition white light, then with the remaining modalities by different blinded endoscopists. All scars biopsied. |
| TXI First | Experimental | Device: Texture and color enhancement imaging (TXI)Scar assessed first with TXI, then with the remaining modalities by different blinded endoscopists. All scars biopsied. |
| GI genius First | Experimental | Device: GI Genius (CADe)Scar assessed first with GI Genius CADe, then with the remaining modalities by different blinded endoscopists. All scars biopsied. |
| NBI First | Experimental | Device: Narrow-band imaging (NBI)Scar assessed first with Narrow Band Imaging (NBI), then with the remaining modalities by different blinded endoscopists. All scars biopsied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Previous endoscopic resection (endoscopic mucosal resection or endoscopic submucosal dissection) of a colorectal lesion ≥15 mm, performed 3 to 6 months before the surveillance colonoscopy.
- Histology of the resected lesion showing an adenoma or a sessile serrated lesion.
- Referral for endoscopic review of the post-polypectomy scar.
- Signed written informed consent.
Key exclusion criteria (5 listed)
- Resected lesion <15 mm.
- Histology of the resected lesion other than adenoma or sessile serrated lesion.
- Incomplete previous resection, or uncertainty about the completeness of the previous resection.
- Patients who, because of age or comorbidity, are not candidates for endoscopic surveillance.
- Failure to complete the study protocol, including biopsy of the scar.
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 |
|---|---|---|
| High-definition white light endoscopy (WLE)Standard high-definition white light assessment of the post-polypectomy scar (EVIS X1, Olympus). | Diagnostic test | WLE first |
| Texture and color enhancement imaging (TXI)Image-enhancement mode of the EVIS X1 platform (Olympus) enhancing texture, brightness and color. | Device | TXI First |
| Narrow-band imaging (NBI)Virtual chromoendoscopy mode of the EVIS X1 platform (Olympus). Added by protocol amendment. | Device | NBI First |
| GI Genius (CADe)Artificial intelligence computer-aided detection system (Medtronic) used during white light assessment of the scar. | Device | GI genius First |
Primary outcome
Sensitivity for histologically confirmed recurrence at the post-polypectomy scar
Time frame: At the surveillance colonoscopy, 3 to 6 months after resection
Proportion of scars with histologically confirmed recurrence that are correctly identified as recurrence by each modality (WLE, TXI, NBI, GI Genius). Recurrence is defined by Higaki criteria (neoplastic tissue within or <5 mm from the scar margins). Reference standard: histology of scar biopsies and resected tissue.
Negative predictive value for histologically confirmed recurrence
Time frame: At the surveillance colonoscopy, 3 to 6 months after resection
Proportion of scars classified as free of recurrence by each modality that show no recurrence on histology.
4 secondary outcomes
Specificity and positive predictive value of each modality
Time frame: 3 to 6 months after resection
Sensitivity and negative predictive value of combined modalities
Time frame: 3 to 6 months after resection
Diagnostic accuracy at the 12-month surveillance colonoscopy
Time frame: 12 months after the first surveillance colonoscopy
Endoscopic characterization of recurrence
Time frame: 3 to 6 months and 12 months after resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Results publication: PubMed 14551863Higaki S, Hashimoto S, Harada K, Nohara H, Saito Y, Gondo T, Okita K. Long-term follow-up of large flat colorectal tumors resected endoscopically. Endoscopy. 2003 Oct;35(10):845-9. doi: 10.1055/s-2003-42622.
- Results publication: PubMed 32371116Repici A, Badalamenti M, Maselli R, Correale L, Radaelli F, Rondonotti E, Ferrara E, Spadaccini M, Alkandari A, Fugazza A, Anderloni A, Galtieri PA, Pellegatta G, Carrara S, Di Leo M, Craviotto V, Lamonaca L, Lorenzetti R, Andrealli A, Antonelli G, Wallace M, Sharma P, Rosch T, Hassan C. Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial. Gastroenterology. 2020 Aug;159(2):512-520.e7. doi: 10.1053/j.gastro.2020.04.062. Epub 2020 May 1.
- Results publication: PubMed 37931908Ortiz O, Daca-Alvarez M, Rivero-Sanchez L, Saez De Gordoa K, Moreira R, Cuatrecasas M, Balaguer F, Pellise M. Linked-color imaging versus high definition white-light endoscopy for evaluation of post-polypectomy scars of nonpedunculated lesions: LCI-Scar study. Endoscopy. 2024 Apr;56(4):283-290. doi: 10.1055/a-2204-3236. Epub 2023 Nov 6.
- Results publication: PubMed 30635409Kandel P, Brand EC, Pelt J, Ball CT, Chen WC, Bouras EP, Gomez V, Raimondo M, Woodward TA, Wallace MB; EMR SCAR Group. Endoscopic scar assessment after colorectal endoscopic mucosal resection scars: when is biopsy necessary (EMR Scar Assessment Project for Endoscope (ESCAPE) trial). Gut. 2019 Sep;68(9):1633-1641. doi: 10.1136/gutjnl-2018-316574. Epub 2019 Jan 11.
- Results publication: PubMed 27343411Desomer L, Tutticci N, Tate DJ, Williams SJ, McLeod D, Bourke MJ. A standardized imaging protocol is accurate in detecting recurrence after EMR. Gastrointest Endosc. 2017 Mar;85(3):518-526. doi: 10.1016/j.gie.2016.06.031. Epub 2016 Jun 22.
- Results publication: PubMed 32572858Hassan C, Antonelli G, Dumonceau JM, Regula J, Bretthauer M, Chaussade S, Dekker E, Ferlitsch M, Gimeno-Garcia A, Jover R, Kalager M, Pellise M, Pox C, Ricciardiello L, Rutter M, Helsingen LM, Bleijenberg A, Senore C, van Hooft JE, Dinis-Ribeiro M, Quintero E. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 Aug;52(8):687-700. doi: 10.1055/a-1185-3109. Epub 2020 Jun 22.
- Results publication: PubMed 24671869Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.
- Individual participant dataSharing planned: Yes. Plan to Share IPD: Yes IPD Sharing Plan Description: De-identified individual participant data underlying the results reported in the publications (diagnostic findings of each modality, histology and baseline characteristics) will be shared upon reasonable request to the principal investigator, after approval of a methodologically sound proposal and signature of a data sharing agreement. Sharing will comply with the General Data Protection Regulation and Spanish Organic Law 3/2018 and may require approval by the Research Ethics Committee of Granada.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-definition white light endoscopy (WLE), Texture and color enhancement imaging (TXI) and Narrow-band imaging (NBI) in people with Colorectal Polyps, run by University Hospital Virgen de las Nieves at 2 sites in Spain.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Redondo Cerezo, MD, PhD (+34 657373336, eredondoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for histologically confirmed recurrence at the post-polypectomy scar (time frame: At the surveillance colonoscopy, 3 to 6 months after resection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07874152, which also lists 7 linked publications.
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 14 Oct 2026.