Colorectal CancerESD vs EMRNCT06815406
Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection vs. Endoscopic Submucosal Dissection
A study testing Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) in people with Colorectal Cancer, run by Azienda USL Reggio Emilia - IRCCS at 5 sites in Italy.
Trial summary
Colorectal cancer is one of the leading causes of cancer-related mortality worldwide. Early-stage non-polypoid neoplastic lesions, particularly Laterally Spreading Tumors - Granular Type (LST-G) larger than 20mm, require effective endoscopic removal to prevent malignant progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 5 sitesItaly
- Study dates
- 18 Nov 2021to Jun 2026
- 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.
- Diagnosis of Laterally Spreading Tumor - Granular Type (LST-G) ≥ 20 mm in the colon or rectum with an indication for endoscopic resection.
- Life expectancy > 10 years.
- Ability to understand and sign the informed consent form, demonstrating comprehension of the study and willingness to participate.
Who cannot join
- Diagnosis of Laterally Spreading Tumor - Non-Granular Type (LST-NG).
- Presence of depressed areas within the lesion.
- Lesions located on a scar or anastomosis site.
- Lesions classified as Kudo Vi or Vn pattern.
- History of chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease).
- Diagnosis of hereditary polyposis syndromes (e.g., familial adenomatous polyposis, Lynch syndrome).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
IRCCS Azienda Ospedaliero Universitaria di Bologna - Sant'Orsola Malpighi
Bologna
Paolo Cecinato, paolo.cecinato@aosp.bo.it
Paolo Cecinato, MD
- Recruiting
Ente Ospedaliero Ospedali Galliera
Genova
Mariachiara Campanale, MD, mchiara.campanale@galliera.it
Mariachiara Campanale, MD
- Recruiting
Università Vita Salute - IRCCS
Milan
Francesco Azzolini, MD, Azzolini.Francesco@hsronline.it
Azzolini Francesco, MD
- Recruiting
Ospedale Civile di Baggiovara
Modena
Giouseppe Grande, MD, giuseppegrande1984@gmail.com
Rita Conigliaro, MD
- Recruiting
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia
Matteo Lucarini, MD, matto.lucarini@ausl.re.it
Romano Sassatelli, MD
About this study
Official title: Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Submucosal Dissection (ESD): A Multicenter Randomized Controlled Trial ( ESD vs EMR )
Colorectal cancer is one of the leading causes of cancer-related mortality worldwide. Early-stage non-polypoid neoplastic lesions, particularly Laterally Spreading Tumors - Granular Type (LST-G) larger than 20mm, require effective endoscopic removal to prevent malignant progression. The two primary techniques for resecting these lesions are Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD).
EMR is a widely used, minimally invasive technique that involves resecting the lesion with a diathermic snare after submucosal injection. While effective and safe, EMR often necessitates piecemeal resection, increasing the risk of local recurrence. In contrast, ESD, developed in Asia, allows for en bloc resection regardless of lesion size, ensuring more accurate histopathological assessment and lower recurrence rates. However, ESD requires greater technical expertise, has longer procedural times, and carries a higher risk of complications.
Read more
In Western clinical practice, EMR remains the standard treatment, whereas ESD is selectively performed in high-expertise centers. Given the lack of randomized controlled trials comparing EMR and ESD in Western populations, this study aims to provide robust clinical evidence to guide treatment decisions.
The primary objective of this study is to compare the recurrence/residual adenomatous tissue rate at 6 and 12 months between EMR and ESD in patients with LST-G lesions of the colon and rectum
- Conditions
- Colorectal Cancer
- Being tested
- Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD)
- Keywords
- Endoscopic Mucosal Resection (EMR), Endoscopic submucosal dissection (ESD), Laterally spreading tumors (LST)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Mucosal Resection (EMR)Procedure or surgery
atients assigned to this arm will undergo Endoscopic Mucosal Resection (EMR), a standard endoscopic technique that involves the resection of colorectal Laterally Spreading Tumors - Granular type (LST-G) using a diathermic snare with submucosal injection. The procedure may be performed en bloc or in a piecemeal fashion, depending on lesion size and characteristics. EMR is widely accepted for lesions with low submucosal invasion risk but has a higher recurrence rate than ESD.
Endoscopic Submucosal Dissection (ESD)Procedure or surgery
Patients assigned to this arm will undergo Endoscopic Submucosal Dissection (ESD), an advanced endoscopic technique that allows for en bloc resection of large colorectal Laterally Spreading Tumors - Granular type (LST-G). The procedure involves the use of specialized knives to dissect the submucosal layer, ensuring complete resection with histologically clear margins (R0 resection). ESD has been associated with lower recurrence rates but requires a high level of expertise, longer procedural times, and carries a higher risk of complications.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Mucosal Resection (EMR) | Active comparator | Not described Receives: Procedure: Endoscopic Mucosal Resection (EMR) |
| Endoscopic Submucosal Dissection (ESD) | Experimental | Not described Receives: Procedure: Endoscopic Submucosal Dissection (ESD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence/Adenomatous Residual Rate
Proportion of patients with local recurrence or residual adenomatous tissue, confirmed through follow-up colonoscopies and histopathological examination.
Measured: 6 and 12 months after treatment
Secondary outcomes (5)
Complete Resection Rate
Proportion of patients with a complete histopathological resection (R0), defined as tumor-free margins in both lateral and deep resection edges, out of the total number of randomized patients
Measured: 6 and 12 months after treatment
Differences in Procedure Time
Comparison of the average duration of the procedure (from submucosal injection to complete lesion resection) between the EMR and ESD groups. The procedure time is measured intraoperatively and is calculated as the total duration from the initial submucosal injection to the completion of lesion resection.
Measured: Up to 2 months
Bleeding Rate
Number of patients experiencing bleeding out of the total number of randomized patients.
Measured: During procedure (up to 2 months from enrollment) and 24 hours and 3 months after treatment
Perforation Rate
Number of patients with an intraoperative perforation, defined as visible mesenteric fat or free peritoneal space during the procedure, or delayed perforation diagnosed based on symptoms (abdominal pain, fever, peritonitis) and confirmed by radiological imaging (free air, fluid collection).
Measured: During procedure (up to 2 months from enrollment) and 24 hours and 3 months after treatment
Overall Complication Rate
Proportion of patients experiencing at least one complication, classified according to the Accordion Severity Classification of Postoperative Complications.
Measured: 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start18 Nov 2021
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sassatelli Romano, MD, Principal investigator, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815406
- Sponsor's protocol ID
- 104/2021/SPER/IRCCSRE
- Acronym
- ESD vs EMR
- Status last verified
- May 2026
- First submitted
- 4 Feb 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bogie RMM, Veldman MHJ, Snijders LARS, Winkens B, Kaltenbach T, Masclee AAM, Matsuda T, Rondagh EJA, Soetikno R, Tanaka S, Chiu HM, Sanduleanu-Dascalescu S. Endoscopic subtypes of colorectal laterally spreading tumors (LSTs) and the risk of submucosal invasion: a meta-analysis. Endoscopy. 2018 Mar;50(3):263-282. doi: 10.1055/s-0043-121144. Epub 2017 Nov 27.
PubMed 29179230Kudo S, Hirota S, Nakajima T, Hosobe S, Kusaka H, Kobayashi T, Himori M, Yagyuu A. Colorectal tumours and pit pattern. J Clin Pathol. 1994 Oct;47(10):880-5. doi: 10.1136/jcp.47.10.880.
PubMed 7962600Oka S, Tanaka S, Saito Y, Iishi H, Kudo SE, Ikematsu H, Igarashi M, Saitoh Y, Inoue Y, Kobayashi K, Hisabe T, Tsuruta O, Sano Y, Yamano H, Shimizu S, Yahagi N, Watanabe T, Nakamura H, Fujii T, Ishikawa H, Sugihara K; Colorectal Endoscopic Resection Standardization Implementation Working Group of the Japanese Society for Cancer of the Colon and Rectum, Tokyo, Japan. Local recurrence after endoscopic resection for large colorectal neoplasia: a multicenter prospective study in Japan. Am J Gastroenterol. 2015 May;110(5):697-707. doi: 10.1038/ajg.2015.96. Epub 2015 Apr 7.
PubMed 25848926Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.
PubMed 28212588Fujiya M, Tanaka K, Dokoshi T, Tominaga M, Ueno N, Inaba Y, Ito T, Moriichi K, Kohgo Y. Efficacy and adverse events of EMR and endoscopic submucosal dissection for the treatment of colon neoplasms: a meta-analysis of studies comparing EMR and endoscopic submucosal dissection. Gastrointest Endosc. 2015 Mar;81(3):583-95. doi: 10.1016/j.gie.2014.07.034. Epub 2015 Jan 13.
PubMed 25592748Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.
PubMed 24986245Pimentel-Nunes P, Dinis-Ribeiro M, Ponchon T, Repici A, Vieth M, De Ceglie A, Amato A, Berr F, Bhandari P, Bialek A, Conio M, Haringsma J, Langner C, Meisner S, Messmann H, Morino M, Neuhaus H, Piessevaux H, Rugge M, Saunders BP, Robaszkiewicz M, Seewald S, Kashin S, Dumonceau JM, Hassan C, Deprez PH. Endoscopic submucosal dissection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2015 Sep;47(9):829-54. doi: 10.1055/s-0034-1392882. Epub 2015 Aug 28.
PubMed 26317585Tanaka S, Kashida H, Saito Y, Yahagi N, Yamano H, Saito S, Hisabe T, Yao T, Watanabe M, Yoshida M, Kudo SE, Tsuruta O, Sugihara KI, Watanabe T, Saitoh Y, Igarashi M, Toyonaga T, Ajioka Y, Ichinose M, Matsui T, Sugita A, Sugano K, Fujimoto K, Tajiri H. JGES guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Dig Endosc. 2015 May;27(4):417-434. doi: 10.1111/den.12456. Epub 2015 Mar 5.
PubMed 25652022Fuccio L, Repici A, Hassan C, Ponchon T, Bhandari P, Jover R, Triantafyllou K, Mandolesi D, Frazzoni L, Bellisario C, Bazzoli F, Sharma P, Rosch T, Rex DK. Why attempt en bloc resection of non-pedunculated colorectal adenomas? A systematic review of the prevalence of superficial submucosal invasive cancer after endoscopic submucosal dissection. Gut. 2018 Aug;67(8):1464-1474. doi: 10.1136/gutjnl-2017-315103. Epub 2017 Dec 5.
PubMed 29208675Strasberg SM, Linehan DC, Hawkins WG. The accordion severity grading system of surgical complications. Ann Surg. 2009 Aug;250(2):177-86. doi: 10.1097/SLA.0b013e3181afde41.
PubMed 19638919Yoshida M, Kakushima N, Mori K, Igarashi K, Kawata N, Tanaka M, Takizawa K, Ito S, Imai K, Hotta K, Ishiwatari H, Matsubayashi H, Ono H. Learning curve and clinical outcome of gastric endoscopic submucosal dissection performed by trainee operators. Surg Endosc. 2017 Sep;31(9):3614-3622. doi: 10.1007/s00464-016-5393-9. Epub 2016 Dec 30.
PubMed 28039646
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Submucosal Dissection (ESD): A Multicenter Randomized Controlled Trial ( ESD vs EMR )
- ClinicalTrials.gov ID
- NCT06815406
- Acronym / sponsor ID
- ESD vs EMR / 104/2021/SPER/IRCCSRE
- Conditions
- Colorectal Cancer
- Keywords
- Endoscopic Mucosal Resection (EMR), Endoscopic submucosal dissection (ESD), Laterally spreading tumors (LST)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 7 Feb 2025 (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.
Colorectal cancer is one of the leading causes of cancer-related mortality worldwide. Early-stage non-polypoid neoplastic lesions, particularly Laterally Spreading Tumors - Granular Type (LST-G) larger than 20mm, require effective endoscopic removal to prevent malignant progression. The two primary techniques for resecting these lesions are Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD).
EMR is a widely used, minimally invasive technique that involves resecting the lesion with a diathermic snare after submucosal injection. While effective and safe, EMR often necessitates piecemeal resection, increasing the risk of local recurrence. In contrast, ESD, developed in Asia, allows for en bloc resection regardless of lesion size, ensuring more accurate histopathological assessment and lower recurrence rates. However, ESD requires greater technical expertise, has longer procedural times, and carries a higher risk of complications.
In Western clinical practice, EMR remains the standard treatment, whereas ESD is selectively performed in high-expertise centers. Given the lack of randomized controlled trials comparing EMR and ESD in Western populations, this study aims to provide robust clinical evidence to guide treatment decisions.
The primary objective of this study is to compare the recurrence/residual adenomatous tissue rate at 6 and 12 months between EMR and ESD in patients with LST-G lesions of the colon and rectum
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Mucosal Resection (EMR) | Active comparator | Procedure: Endoscopic Mucosal Resection (EMR) |
| Endoscopic Submucosal Dissection (ESD) | Experimental | Procedure: Endoscopic Submucosal Dissection (ESD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Diagnosis of Laterally Spreading Tumor - Granular Type (LST-G) ≥ 20 mm in the colon or rectum with an indication for endoscopic resection.
- Life expectancy > 10 years.
- Ability to understand and sign the informed consent form, demonstrating comprehension of the study and willingness to participate.
Key exclusion criteria (6 listed)
- Diagnosis of Laterally Spreading Tumor - Non-Granular Type (LST-NG).
- Presence of depressed areas within the lesion.
- Lesions located on a scar or anastomosis site.
- Lesions classified as Kudo Vi or Vn pattern.
- History of chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease).
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 |
|---|---|---|
| Endoscopic Mucosal Resection (EMR)atients assigned to this arm will undergo Endoscopic Mucosal Resection (EMR), a standard endoscopic technique that involves the resection of colorectal Laterally Spreading Tumors - Granular type (LST-G) using a diathermic snare with submucosal injection. The procedure may be performed en bloc or in a piecemeal fashion, depending on lesion size and characteristics. EMR is widely accepted for lesions with low submucosal invasion risk but has a higher recurrence rate than ESD. | Procedure or surgery | Endoscopic Mucosal Resection (EMR) |
| Endoscopic Submucosal Dissection (ESD)Patients assigned to this arm will undergo Endoscopic Submucosal Dissection (ESD), an advanced endoscopic technique that allows for en bloc resection of large colorectal Laterally Spreading Tumors - Granular type (LST-G). The procedure involves the use of specialized knives to dissect the submucosal layer, ensuring complete resection with histologically clear margins (R0 resection). ESD has been associated with lower recurrence rates but requires a high level of expertise, longer procedural times, and carries a higher risk of complications. | Procedure or surgery | Endoscopic Submucosal Dissection (ESD) |
Primary outcome
Recurrence/Adenomatous Residual Rate
Time frame: 6 and 12 months after treatment
Proportion of patients with local recurrence or residual adenomatous tissue, confirmed through follow-up colonoscopies and histopathological examination.
5 secondary outcomes
Complete Resection Rate
Time frame: 6 and 12 months after treatment
Differences in Procedure Time
Time frame: Up to 2 months
Bleeding Rate
Time frame: During procedure (up to 2 months from enrollment) and 24 hours and 3 months after treatment
Perforation Rate
Time frame: During procedure (up to 2 months from enrollment) and 24 hours and 3 months after treatment
Overall Complication Rate
Time frame: 24 hours after treatment
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 6 May 2026.
- Background: PubMed 29179230Bogie RMM, Veldman MHJ, Snijders LARS, Winkens B, Kaltenbach T, Masclee AAM, Matsuda T, Rondagh EJA, Soetikno R, Tanaka S, Chiu HM, Sanduleanu-Dascalescu S. Endoscopic subtypes of colorectal laterally spreading tumors (LSTs) and the risk of submucosal invasion: a meta-analysis. Endoscopy. 2018 Mar;50(3):263-282. doi: 10.1055/s-0043-121144. Epub 2017 Nov 27.
- Background: PubMed 7962600Kudo S, Hirota S, Nakajima T, Hosobe S, Kusaka H, Kobayashi T, Himori M, Yagyuu A. Colorectal tumours and pit pattern. J Clin Pathol. 1994 Oct;47(10):880-5. doi: 10.1136/jcp.47.10.880.
- Background: PubMed 25848926Oka S, Tanaka S, Saito Y, Iishi H, Kudo SE, Ikematsu H, Igarashi M, Saitoh Y, Inoue Y, Kobayashi K, Hisabe T, Tsuruta O, Sano Y, Yamano H, Shimizu S, Yahagi N, Watanabe T, Nakamura H, Fujii T, Ishikawa H, Sugihara K; Colorectal Endoscopic Resection Standardization Implementation Working Group of the Japanese Society for Cancer of the Colon and Rectum, Tokyo, Japan. Local recurrence after endoscopic resection for large colorectal neoplasia: a multicenter prospective study in Japan. Am J Gastroenterol. 2015 May;110(5):697-707. doi: 10.1038/ajg.2015.96. Epub 2015 Apr 7.
- Background: PubMed 28212588Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.
- Background: PubMed 25592748Fujiya M, Tanaka K, Dokoshi T, Tominaga M, Ueno N, Inaba Y, Ito T, Moriichi K, Kohgo Y. Efficacy and adverse events of EMR and endoscopic submucosal dissection for the treatment of colon neoplasms: a meta-analysis of studies comparing EMR and endoscopic submucosal dissection. Gastrointest Endosc. 2015 Mar;81(3):583-95. doi: 10.1016/j.gie.2014.07.034. Epub 2015 Jan 13.
- Background: PubMed 24986245Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.
- Background: PubMed 26317585Pimentel-Nunes P, Dinis-Ribeiro M, Ponchon T, Repici A, Vieth M, De Ceglie A, Amato A, Berr F, Bhandari P, Bialek A, Conio M, Haringsma J, Langner C, Meisner S, Messmann H, Morino M, Neuhaus H, Piessevaux H, Rugge M, Saunders BP, Robaszkiewicz M, Seewald S, Kashin S, Dumonceau JM, Hassan C, Deprez PH. Endoscopic submucosal dissection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2015 Sep;47(9):829-54. doi: 10.1055/s-0034-1392882. Epub 2015 Aug 28.
- Background: PubMed 25652022Tanaka S, Kashida H, Saito Y, Yahagi N, Yamano H, Saito S, Hisabe T, Yao T, Watanabe M, Yoshida M, Kudo SE, Tsuruta O, Sugihara KI, Watanabe T, Saitoh Y, Igarashi M, Toyonaga T, Ajioka Y, Ichinose M, Matsui T, Sugita A, Sugano K, Fujimoto K, Tajiri H. JGES guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Dig Endosc. 2015 May;27(4):417-434. doi: 10.1111/den.12456. Epub 2015 Mar 5.
- Background: PubMed 29208675Fuccio L, Repici A, Hassan C, Ponchon T, Bhandari P, Jover R, Triantafyllou K, Mandolesi D, Frazzoni L, Bellisario C, Bazzoli F, Sharma P, Rosch T, Rex DK. Why attempt en bloc resection of non-pedunculated colorectal adenomas? A systematic review of the prevalence of superficial submucosal invasive cancer after endoscopic submucosal dissection. Gut. 2018 Aug;67(8):1464-1474. doi: 10.1136/gutjnl-2017-315103. Epub 2017 Dec 5.
- Background: PubMed 19638919Strasberg SM, Linehan DC, Hawkins WG. The accordion severity grading system of surgical complications. Ann Surg. 2009 Aug;250(2):177-86. doi: 10.1097/SLA.0b013e3181afde41.
- Background: PubMed 28039646Yoshida M, Kakushima N, Mori K, Igarashi K, Kawata N, Tanaka M, Takizawa K, Ito S, Imai K, Hotta K, Ishiwatari H, Matsubayashi H, Ono H. Learning curve and clinical outcome of gastric endoscopic submucosal dissection performed by trainee operators. Surg Endosc. 2017 Sep;31(9):3614-3622. doi: 10.1007/s00464-016-5393-9. Epub 2016 Dec 30.
- Individual participant dataSharing planned: No
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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.
Sassatelli Romano, MD principal investigator
Azienda USL Reggio Emilia - IRCCS
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) in people with Colorectal Cancer, run by Azienda USL Reggio Emilia - IRCCS at 5 sites in Italy.
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 4 inclusion and 6 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. 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 Lucarini Matteo, MD (+39 0522 296423, matteo.lucarini@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence/Adenomatous Residual Rate (time frame: 6 and 12 months after treatment). 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 NCT06815406, which also lists 11 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 6 May 2026.