Precancerous LesionsWave-ESDNCT07040020
This Randomized, Single-center Trial Aims to Evaluate the Advantages of Underwater ESD (U-ESD) in Comparison to the Conventional ESD (C-ESD).
A study testing Underwater ESD (U-ESD) and Conventional ESD (C-ESD) in people with Precancerous Lesions, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Large nonpedunculated colorectal lesions are increasingly detected thanks to screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps. Nevertheless, colorectal ESD is burdened by technical difficulties and several adverse events affecting its outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Precancerous Lesions
- What is being tested?
- Underwater ESD (U-ESD) and Conventional ESD (C-ESD)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2025to 26 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients ≥ 18 years of age with indication of ESD for large (\>20mm) nonpedunculated colorectal polyps
- patients who were able to give informed written consent
Who cannot join
- Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn)
- Suspicion of serrated/hyperplastic polyps by analysis of pit pattern (Kudo IIo)
- Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)
- Polyp involving the anal verge
- Polyp inside the ileo-cecal valvula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Water-Assisted Versus Standard ESD for Large Nonpedunculated Colorectal Polyps: a Prospective Randomized Trial
Large nonpedunculated colorectal lesions are increasingly detected thanks to screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps.
Nevertheless, colorectal ESD is burdened by technical difficulties and several adverse events affecting its outcomes. The adverse events could be life-threatening, call for or prolong the hospitalization, require blood transfusion, additional endoscopic or surgical procedures and increase costs. Failure of endoscopic resection requiring surgery for benign lesions could affect patients' quality of life and increase healthcare systems' costs.
Read more
Thus, improving colorectal ESD outcomes is an important clinical and medico-economic objective. The underwater setting with saline has been already established as a better option than conventional CO2 insufflation for EMR of large colonic polyps. Moreover, use of the underwater approach for colorectal ESD has been increasingly reported with good results in the last few years. However, a randomized comparative trial between conventional and underwater colorectal ESD clarifying which should be the preferred approach is lacking.
Expected benefits are a decrease of adverse events and an increase of successful R0 resection rate of colorectal ESD.
Read the detailed description
The procedure in this study involves the application of underwater ESD for the resection of large nonpedunculated colorectal polyps.
Underwater ESD is a technique wherein the polyp is removed in an en bloc fashion. The procedure initiates with the identification and delineation of the polyp borders through careful endoscopic examination. Subsequently, after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed to lift the lesion. After that, subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection will be performed.
The clinical practice and technique of underwater ESD and conventional ESD performed during the course of the trial, will not be modified from standard clinical practice.
- Conditions
- Precancerous Lesions
- Being tested
- Underwater ESD (U-ESD), Conventional ESD (C-ESD)
- Keywords
- esd, large nonpedunculated colorectal polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underwater ESD (U-ESD)Procedure or surgery
Underwater ESD (U-ESD): after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out
Conventional ESD (C-ESD)Other
Conventional ESD (C-ESD): under CO2 insufflation, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out.
| Study group | Role | What they receive |
|---|---|---|
| Conventional ESD | Active comparator | Conventional ESD (C-ESD): under CO2 insufflation, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out Receives: Other: Conventional ESD (C-ESD) |
| Underwater ESD (U-ESD) | Experimental | Underwater ESD (U-ESD): after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out. Receives: Procedure: Underwater ESD (U-ESD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection
Rate of successful and safe endoscopic resection defined as an R0 resection with no major adverse events (defined as any major procedure-related complication, such as delayed bleeding, intraprocedural and delayed perforation or post-electrocoagulation syndrome)
Measured: 24 hours
Secondary outcomes (3)
Compare
Compare the:
- mean procedural time;
- rate of en bloc resection;
- rate of R0 resection;
- rate of curative resection;
- length of hospitalization;
- rate of intraprocedural perforation;
- rate of intraprocedural bleeding.
Measured: at 24 hours
delayed perforation
To compare the proportion of delayed perforation between the two groups
Measured: at 1 months
proportion of post-electrocoagulation syndrome
To compare the proportion of post-electrocoagulation syndrome between the two groups
Measured: at Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start31 Mar 2025
- Primary completion26 Mar 2026
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Precancerous LesionsStudies 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040020
- Sponsor's protocol ID
- ID 4139 Wave-ESD
- Acronym
- Wave-ESD
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koyama Y, Fukuzawa M, Aikawa H, Nemoto D, Muramatsu T, Matsumoto T, Uchida K, Madarame A, Morise T, Yamaguchi H, Kono S, Nagata N, Sugimoto M, Kawai T, Saito Y, Itoi T. Underwater endoscopic submucosal dissection for colorectal tumors decreases the incidence of post-electrocoagulation syndrome. J Gastroenterol Hepatol. 2023 Sep;38(9):1566-1575. doi: 10.1111/jgh.16259. Epub 2023 Jun 15.
PubMed 37321649Yamamoto H, Hayashi Y, Despott EJ. The pocket-creation method for endoscopic submucosal dissection combined with saline-immersion: another potential option to overcome challenges in colorectal endoscopic submucosal dissection. Gastrointest Endosc. 2019 Aug;90(2):288-289. doi: 10.1016/j.gie.2019.04.244. No abstract available.
PubMed 31327340Capogreco A, Hassan C, De Blasio F, Massimi D, de Sire R, Galtieri PA, Despott EJ, Alkandari A, Bhandari P, Facciorusso A, Maselli R, Repici A. Prophylactic underwater vessel coagulation for submucosal endoscopy. Gut. 2024 Jun 6;73(7):1049-1051. doi: 10.1136/gutjnl-2024-332002. No abstract available.
PubMed 38383144Despott EJ, Hirayama Y, Lazaridis N, Koukias N, Telese A, Hayashi Y, Miura Y, Yamamoto H, Murino A. Saline immersion therapeutic endoscopy facilitated pocket-creation method for endoscopic submucosal dissection (with video). Gastrointest Endosc. 2019 Mar;89(3):652-653. doi: 10.1016/j.gie.2018.10.005. No abstract available.
PubMed 30784510Spadaccini M, Fuccio L, Lamonaca L, Frazzoni L, Maselli R, Di Leo M, Galtieri PA, Craviotto V, D'Amico F, Hassan C, Repici A. Underwater EMR for colorectal lesions: a systematic review with meta-analysis (with video). Gastrointest Endosc. 2019 Jun;89(6):1109-1116.e4. doi: 10.1016/j.gie.2018.10.023. Epub 2018 Oct 25.
PubMed 30862352Tseng CW, Hsieh YH, Lin CC, Koo M, Leung FW. Heat sink effect of underwater polypectomy in a porcine colon model. BMC Gastroenterol. 2021 Oct 27;21(1):406. doi: 10.1186/s12876-021-01985-1.
PubMed 34706664Lenz L, Martins B, Andrade de Paulo G, Kawaguti FS, Baba ER, Uemura RS, Gusmon CC, Geiger SN, Moura RN, Pennacchi C, Simas de Lima M, Safatle-Ribeiro AV, Hashimoto CL, Ribeiro U, Maluf-Filho F. Underwater versus conventional EMR for nonpedunculated colorectal lesions: a randomized clinical trial. Gastrointest Endosc. 2023 Mar;97(3):549-558. doi: 10.1016/j.gie.2022.10.033. Epub 2022 Oct 26.
PubMed 36309072Nagl S, Ebigbo A, Goelder SK, Roemmele C, Neuhaus L, Weber T, Braun G, Probst A, Schnoy E, Kafel AJ, Muzalyova A, Messmann H. Underwater vs Conventional Endoscopic Mucosal Resection of Large Sessile or Flat Colorectal Polyps: A Prospective Randomized Controlled Trial. Gastroenterology. 2021 Nov;161(5):1460-1474.e1. doi: 10.1053/j.gastro.2021.07.044. Epub 2021 Aug 8.
PubMed 34371000Binmoeller KF, Weilert F, Shah J, Bhat Y, Kane S. "Underwater" EMR without submucosal injection for large sessile colorectal polyps (with video). Gastrointest Endosc. 2012 May;75(5):1086-91. doi: 10.1016/j.gie.2011.12.022. Epub 2012 Feb 25.
PubMed 22365184Arezzo A, Passera R, Marchese N, Galloro G, Manta R, Cirocchi R. Systematic review and meta-analysis of endoscopic submucosal dissection vs endoscopic mucosal resection for colorectal lesions. United European Gastroenterol J. 2016 Feb;4(1):18-29. doi: 10.1177/2050640615585470. Epub 2015 May 5.
PubMed 26966519Stephane S, Timothee W, Jeremie A, Raphael O, Martin D, Emmanuelle P, Elodie L, Quentin D, Nikki C, Sonia B, Hugo L, Guillaume G, Romain L, Mathieu P, Sophie G, Jeremie J. Endoscopic submucosal dissection or piecemeal endoscopic mucosal resection for large superficial colorectal lesions: A cost effectiveness study. Clin Res Hepatol Gastroenterol. 2022 Jun-Jul;46(6):101969. doi: 10.1016/j.clinre.2022.101969. Epub 2022 Jun 1.
PubMed 35659602Jacques J, Schaefer M, Wallenhorst T, Rosch T, Lepilliez V, Chaussade S, Rivory J, Legros R, Chevaux JB, Leblanc S, Rostain F, Barret M, Albouys J, Belle A, Labrunie A, Preux PM, Lepetit H, Dahan M, Ponchon T, Crepin S, Marais L, Magne J, Pioche M. Endoscopic En Bloc Versus Piecemeal Resection of Large Nonpedunculated Colonic Adenomas : A Randomized Comparative Trial. Ann Intern Med. 2024 Jan;177(1):29-38. doi: 10.7326/M23-1812. Epub 2023 Dec 12.
PubMed 38079634Nishihara R, Wu K, Lochhead P, Morikawa T, Liao X, Qian ZR, Inamura K, Kim SA, Kuchiba A, Yamauchi M, Imamura Y, Willett WC, Rosner BA, Fuchs CS, Giovannucci E, Ogino S, Chan AT. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013 Sep 19;369(12):1095-105. doi: 10.1056/NEJMoa1301969.
PubMed 24047059Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, Bresalier R, Andriole GL, Buys SS, Crawford ED, Fouad MN, Isaacs C, Johnson CC, Reding DJ, O'Brien B, Carrick DM, Wright P, Riley TL, Purdue MP, Izmirlian G, Kramer BS, Miller AB, Gohagan JK, Prorok PC, Berg CD; PLCO Project Team. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med. 2012 Jun 21;366(25):2345-57. doi: 10.1056/NEJMoa1114635. Epub 2012 May 21.
PubMed 22612596Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
PubMed 29313949
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water-Assisted Versus Standard ESD for Large Nonpedunculated Colorectal Polyps: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07040020
- Acronym / sponsor ID
- Wave-ESD / ID 4139 Wave-ESD
- Conditions
- Precancerous Lesions
- Keywords
- esd, large nonpedunculated colorectal polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 26 Jun 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.
Large nonpedunculated colorectal lesions are increasingly detected thanks to screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps.
Nevertheless, colorectal ESD is burdened by technical difficulties and several adverse events affecting its outcomes. The adverse events could be life-threatening, call for or prolong the hospitalization, require blood transfusion, additional endoscopic or surgical procedures and increase costs. Failure of endoscopic resection requiring surgery for benign lesions could affect patients' quality of life and increase healthcare systems' costs.
Thus, improving colorectal ESD outcomes is an important clinical and medico-economic objective. The underwater setting with saline has been already established as a better option than conventional CO2 insufflation for EMR of large colonic polyps. Moreover, use of the underwater approach for colorectal ESD has been increasingly reported with good results in the last few years. However, a randomized comparative trial between conventional and underwater colorectal ESD clarifying which should be the preferred approach is lacking.
Expected benefits are a decrease of adverse events and an increase of successful R0 resection rate of colorectal ESD.
Detailed description
The procedure in this study involves the application of underwater ESD for the resection of large nonpedunculated colorectal polyps.
Underwater ESD is a technique wherein the polyp is removed in an en bloc fashion. The procedure initiates with the identification and delineation of the polyp borders through careful endoscopic examination. Subsequently, after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed to lift the lesion. After that, subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection will be performed.
The clinical practice and technique of underwater ESD and conventional ESD performed during the course of the trial, will not be modified from standard clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ESD | Active comparator | Other: Conventional ESD (C-ESD)Conventional ESD (C-ESD): under CO2 insufflation, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out |
| Underwater ESD (U-ESD) | Experimental | Procedure: Underwater ESD (U-ESD)Underwater ESD (U-ESD): after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients ≥ 18 years of age with indication of ESD for large (\>20mm) nonpedunculated colorectal polyps
- patients who were able to give informed written consent
Key exclusion criteria (5 listed)
- Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn)
- Suspicion of serrated/hyperplastic polyps by analysis of pit pattern (Kudo IIo)
- Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)
- Polyp involving the anal verge
- Polyp inside the ileo-cecal valvula
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 |
|---|---|---|
| Underwater ESD (U-ESD)Underwater ESD (U-ESD): after filling the lumen with saline and sucking all the air, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out | Procedure or surgery | Underwater ESD (U-ESD) |
| Conventional ESD (C-ESD)Conventional ESD (C-ESD): under CO2 insufflation, initial submucosal injection of saline and methylene blue is performed; subsequent mucosal incision with ESD knife all around the lesion and submucosal dissection deep in the submucosal layer leading to an en bloc resection is carried out. | Other | Conventional ESD |
Primary outcome
R0 resection
Time frame: 24 hours
Rate of successful and safe endoscopic resection defined as an R0 resection with no major adverse events (defined as any major procedure-related complication, such as delayed bleeding, intraprocedural and delayed perforation or post-electrocoagulation syndrome)
3 secondary outcomes
Compare
Time frame: at 24 hours
delayed perforation
Time frame: at 1 months
proportion of post-electrocoagulation syndrome
Time frame: at Day 7
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 21 Apr 2026.
- Results publication: PubMed 37321649Koyama Y, Fukuzawa M, Aikawa H, Nemoto D, Muramatsu T, Matsumoto T, Uchida K, Madarame A, Morise T, Yamaguchi H, Kono S, Nagata N, Sugimoto M, Kawai T, Saito Y, Itoi T. Underwater endoscopic submucosal dissection for colorectal tumors decreases the incidence of post-electrocoagulation syndrome. J Gastroenterol Hepatol. 2023 Sep;38(9):1566-1575. doi: 10.1111/jgh.16259. Epub 2023 Jun 15.
- Results publication: PubMed 31327340Yamamoto H, Hayashi Y, Despott EJ. The pocket-creation method for endoscopic submucosal dissection combined with saline-immersion: another potential option to overcome challenges in colorectal endoscopic submucosal dissection. Gastrointest Endosc. 2019 Aug;90(2):288-289. doi: 10.1016/j.gie.2019.04.244. No abstract available.
- Results publication: PubMed 38383144Capogreco A, Hassan C, De Blasio F, Massimi D, de Sire R, Galtieri PA, Despott EJ, Alkandari A, Bhandari P, Facciorusso A, Maselli R, Repici A. Prophylactic underwater vessel coagulation for submucosal endoscopy. Gut. 2024 Jun 6;73(7):1049-1051. doi: 10.1136/gutjnl-2024-332002. No abstract available.
- Results publication: PubMed 30784510Despott EJ, Hirayama Y, Lazaridis N, Koukias N, Telese A, Hayashi Y, Miura Y, Yamamoto H, Murino A. Saline immersion therapeutic endoscopy facilitated pocket-creation method for endoscopic submucosal dissection (with video). Gastrointest Endosc. 2019 Mar;89(3):652-653. doi: 10.1016/j.gie.2018.10.005. No abstract available.
- Results publication: PubMed 30862352Spadaccini M, Fuccio L, Lamonaca L, Frazzoni L, Maselli R, Di Leo M, Galtieri PA, Craviotto V, D'Amico F, Hassan C, Repici A. Underwater EMR for colorectal lesions: a systematic review with meta-analysis (with video). Gastrointest Endosc. 2019 Jun;89(6):1109-1116.e4. doi: 10.1016/j.gie.2018.10.023. Epub 2018 Oct 25.
- Results publication: PubMed 34706664Tseng CW, Hsieh YH, Lin CC, Koo M, Leung FW. Heat sink effect of underwater polypectomy in a porcine colon model. BMC Gastroenterol. 2021 Oct 27;21(1):406. doi: 10.1186/s12876-021-01985-1.
- Results publication: PubMed 36309072Lenz L, Martins B, Andrade de Paulo G, Kawaguti FS, Baba ER, Uemura RS, Gusmon CC, Geiger SN, Moura RN, Pennacchi C, Simas de Lima M, Safatle-Ribeiro AV, Hashimoto CL, Ribeiro U, Maluf-Filho F. Underwater versus conventional EMR for nonpedunculated colorectal lesions: a randomized clinical trial. Gastrointest Endosc. 2023 Mar;97(3):549-558. doi: 10.1016/j.gie.2022.10.033. Epub 2022 Oct 26.
- Results publication: PubMed 34371000Nagl S, Ebigbo A, Goelder SK, Roemmele C, Neuhaus L, Weber T, Braun G, Probst A, Schnoy E, Kafel AJ, Muzalyova A, Messmann H. Underwater vs Conventional Endoscopic Mucosal Resection of Large Sessile or Flat Colorectal Polyps: A Prospective Randomized Controlled Trial. Gastroenterology. 2021 Nov;161(5):1460-1474.e1. doi: 10.1053/j.gastro.2021.07.044. Epub 2021 Aug 8.
- Results publication: PubMed 22365184Binmoeller KF, Weilert F, Shah J, Bhat Y, Kane S. "Underwater" EMR without submucosal injection for large sessile colorectal polyps (with video). Gastrointest Endosc. 2012 May;75(5):1086-91. doi: 10.1016/j.gie.2011.12.022. Epub 2012 Feb 25.
- Results publication: PubMed 26966519Arezzo A, Passera R, Marchese N, Galloro G, Manta R, Cirocchi R. Systematic review and meta-analysis of endoscopic submucosal dissection vs endoscopic mucosal resection for colorectal lesions. United European Gastroenterol J. 2016 Feb;4(1):18-29. doi: 10.1177/2050640615585470. Epub 2015 May 5.
- Results publication: PubMed 35659602Stephane S, Timothee W, Jeremie A, Raphael O, Martin D, Emmanuelle P, Elodie L, Quentin D, Nikki C, Sonia B, Hugo L, Guillaume G, Romain L, Mathieu P, Sophie G, Jeremie J. Endoscopic submucosal dissection or piecemeal endoscopic mucosal resection for large superficial colorectal lesions: A cost effectiveness study. Clin Res Hepatol Gastroenterol. 2022 Jun-Jul;46(6):101969. doi: 10.1016/j.clinre.2022.101969. Epub 2022 Jun 1.
- Results publication: PubMed 38079634Jacques J, Schaefer M, Wallenhorst T, Rosch T, Lepilliez V, Chaussade S, Rivory J, Legros R, Chevaux JB, Leblanc S, Rostain F, Barret M, Albouys J, Belle A, Labrunie A, Preux PM, Lepetit H, Dahan M, Ponchon T, Crepin S, Marais L, Magne J, Pioche M. Endoscopic En Bloc Versus Piecemeal Resection of Large Nonpedunculated Colonic Adenomas : A Randomized Comparative Trial. Ann Intern Med. 2024 Jan;177(1):29-38. doi: 10.7326/M23-1812. Epub 2023 Dec 12.
- Individual participant dataSharing planned: Undecided
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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 Underwater ESD (U-ESD) and Conventional ESD (C-ESD) in people with Precancerous Lesions, run by Istituto Clinico Humanitas at 1 site 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 2 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: finished, as of the sponsor's last update on 21 Apr 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 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?
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?
R0 resection (time frame: 24 hours). 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 NCT07040020, which also lists 17 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 21 Apr 2026.