Colorectal NeoplasiaTIDENCT07490574
Trial of Underwater Versus Gas-Insufflation Colorectal Endoscopic Submucosal DisseEtion
A study testing Underwater ESD (UESD) and Conventional Gas-Assisted ESD (GESD) in people with Colorectal Neoplasia and Colorectal Superficial Neoplasia, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Colorectal endoscopic submucosal dissection (ESD) enables en bloc resection of large superficial colorectal neoplasia but remains technically demanding and may be limited by suboptimal visualization, intraprocedural bleeding, smoke accumulation, and prolonged procedural time. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colorectal Neoplasia, Colorectal Superficial Neoplasia, Colorectal Precancerous Lesions
- What is being tested?
- Underwater ESD (UESD) and Conventional Gas-Assisted ESD (GESD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2024to 1 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older
- Colorectal neoplastic lesion referred for endoscopic submucosal dissection
- Lesion considered amenable to en bloc endoscopic resection by ESD according to expert pre-procedural endoscopic assessment
- Written informed consent provided
Who cannot join
- Known or suspected deep invasive neoplasia
- Inflammatory bowel disease
- Uninterrupted antithrombotic therapy
- Known coagulopathy
- Any clinical or lesion-related condition considered unsuitable for colorectal ESD by the treating endoscopist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Underwater Versus Conventional Endoscopic Submucosal Dissection For Colorectal Neoplasia: A Multicenter, Randomised Controlled Trial
Colorectal endoscopic submucosal dissection (ESD) enables en bloc resection of large superficial colorectal neoplasia but remains technically demanding and may be limited by suboptimal visualization, intraprocedural bleeding, smoke accumulation, and prolonged procedural time. Underwater ESD (UESD), performed under saline immersion rather than gas insufflation, has been proposed as a strategy to improve the operative field and facilitate submucosal dissection.
This prospective, multicenter, open-label, randomized controlled trial was designed to compare UESD with conventional gas-assisted ESD (GESD) for colorectal neoplasia referred for ESD across Italian tertiary centers. The primary objective was to assess non-inferiority of UESD versus GESD in terms of en bloc resection. Secondary objectives included comparison of histological resection quality, procedural efficiency, intraprocedural events, procedural field visualization, and post-procedural adverse events.
Read the detailed description
Colorectal ESD is an established organ-preserving technique for the en bloc resection of superficial colorectal neoplasia, particularly when conventional endoscopic mucosal resection is unlikely to achieve complete single-piece excision. However, colorectal ESD is technically demanding because of the thin colonic wall, unstable scope position, narrow submucosal space, intraprocedural bleeding, smoke generation, and difficulty in maintaining a stable dissection plane.
Underwater ESD has emerged as a modified operative environment in which luminal insufflation is discontinued and the target segment is immersed in saline. Saline immersion may improve visualization of the submucosal layer and of submucosal vessels, limit smoke persistence in the operative field, and facilitate more stable dissection. Although initial retrospective and comparative experiences have suggested procedural advantages of underwater ESD, high-quality randomized comparative data remain limited, particularly in Western multicenter practice.
This study was therefore designed as a prospective multicenter randomized trial across Italian tertiary referral centers to compare underwater ESD with conventional gas-assisted ESD for colorectal neoplasia referred for ESD. Patients were allocated 1:1 to either UESD or GESD. The primary endpoint was en bloc resection. Secondary endpoints included R0 resection, procedural time, dissection speed, intraprocedural bleeding, need for hemostatic forceps, smoke interference, vessel visualization, cutting-plane visualization, post-procedural pain, post-ESD coagulation syndrome, perforation, and delayed bleeding. The technical conduct of ESD apart from the assigned luminal environment was left to expert operator discretion in order to preserve real-world tertiary-center practice.
- Being tested
- Underwater ESD (UESD), Conventional Gas-Assisted ESD (GESD)
- Keywords
- colorectal ESD, underwater ESD, endoscopic submucosal dissection, colorectal neoplasia, en bloc resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underwater ESD (UESD)Procedure or surgery
Underwater ESD (UESD) performed under saline immersion with luminal insufflation turned off.
Conventional Gas-Assisted ESD (GESD)Procedure or surgery
Conventional colorectal ESD was performed under gas insufflation according to standard practice at each participating center. Mucosal incision and submucosal dissection were carried out according to standard ESD technique. Device selection, generator settings, and technical dissection strategy were left to operator discretion. Hemostasis, when required, was achieved using hemostatic forceps.
| Study group | Role | What they receive |
|---|---|---|
| Underwater Endoscopic Submucosal Dissection (UESD) | Experimental | Underwater endoscopic submucosal dissection was performed after placement of the lesion on the anti-gravity side whenever feasible, discontinuation of luminal insufflation, and filling of the target colonic segment with saline solution to obtain stable immersion of the operative field. After immersion, mucosal incision and submucosal dissection were completed according to standard ESD principles, using either a conventional stepwise or tunnel-based strategy according to lesion characteristics and operator preference. Only saline solution was standardized across centers; device selection, generator settings, and ancillary maneuvers were otherwise left to operator discretion. Hemostasis, when required, was achieved using hemostatic forceps. Receives: Procedure: Underwater ESD (UESD) |
| Conventional Gas-Assisted Endoscopic Submucosal Dissection (GESD) | Active comparator | Conventional colorectal ESD was performed under gas insufflation according to standard practice at each participating center. Mucosal incision and submucosal dissection were carried out according to standard ESD technique. Device selection, generator settings, and technical dissection strategy were left to operator discretion. Hemostasis, when required, was achieved using hemostatic forceps. Receives: Procedure: Conventional Gas-Assisted ESD (GESD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
En bloc resection rate
Proportion of lesions resected in a single specimen.
Measured: During the index procedure
Secondary outcomes (12)
R0 resection rate
Proportion of lesions resected en bloc with histologically negative lateral and vertical margins.
Measured: During index procedure and histopathological assessment within 30 days
Procedural time
Time from submucosal injection to completion of lesion dissection.
Measured: During the index procedure
Dissection speed
Rate of dissection calculated by dividing specimen area by dissection time.
Measured: During the index procedure
Intraprocedural bleeding rate
Proportion of procedures with any bleeding occurring during ESD.
Measured: During the index procedure
Use of hemostatic forceps
Proportion of procedures requiring coagulation forceps for active bleeding or prophylactic vessel coagulation.
Measured: During the index procedure
Smoke interference
Proportion of procedures in which electrocautery-generated fumes/particulate matter impaired visualization and required repeated lens irrigation or temporary withdrawal.
Measured: During the index procedure
Vessel visualization score
Operator-reported 5-point Likert score assessing clarity of identification of submucosal vessels during dissection. Lower scores indicate better visualization.
Measured: Immediately after the index procedure
Cutting-plane visualization score
Operator-reported 5-point Likert score assessing clarity of the dissection interface between submucosa and muscularis propria. Lower scores indicate better visualization.
Measured: Immediately after the index procedure
Post-procedural abdominal pain
Post-procedural pain assessed on a 0-3 numerical scale by nursing staff.
Measured: 15, 30, and 60 minutes after the procedure
Post-ESD coagulation syndrome (PECS)
Proportion of patients with abdominal distension or pain at the resection site associated with fever or inflammatory response in the absence of documented perforation.
Measured: Within 7 days
Perforation rate
Proportion of intraprocedural or delayed perforations.
Measured: From procedure to 30 days
Delayed bleeding rate
Proportion of patients with clinically overt post-procedural bleeding or hemoglobin decrease >2 g/dL without another source.
Measured: From procedure to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Dec 2024
- Primary completion1 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasiaStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University
- Responsible party
- Principal investigator, Giulio Antonelli, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490574
- Sponsor's protocol ID
- TIDE
- Acronym
- TIDE
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymsed data upon written and motivated requests
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underwater Versus Conventional Endoscopic Submucosal Dissection For Colorectal Neoplasia: A Multicenter, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07490574
- Acronym / sponsor ID
- TIDE / TIDE
- Keywords
- colorectal ESD, underwater ESD, endoscopic submucosal dissection, colorectal neoplasia, en bloc resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 24 Mar 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.
Colorectal endoscopic submucosal dissection (ESD) enables en bloc resection of large superficial colorectal neoplasia but remains technically demanding and may be limited by suboptimal visualization, intraprocedural bleeding, smoke accumulation, and prolonged procedural time. Underwater ESD (UESD), performed under saline immersion rather than gas insufflation, has been proposed as a strategy to improve the operative field and facilitate submucosal dissection.
This prospective, multicenter, open-label, randomized controlled trial was designed to compare UESD with conventional gas-assisted ESD (GESD) for colorectal neoplasia referred for ESD across Italian tertiary centers. The primary objective was to assess non-inferiority of UESD versus GESD in terms of en bloc resection. Secondary objectives included comparison of histological resection quality, procedural efficiency, intraprocedural events, procedural field visualization, and post-procedural adverse events.
Detailed description
Colorectal ESD is an established organ-preserving technique for the en bloc resection of superficial colorectal neoplasia, particularly when conventional endoscopic mucosal resection is unlikely to achieve complete single-piece excision. However, colorectal ESD is technically demanding because of the thin colonic wall, unstable scope position, narrow submucosal space, intraprocedural bleeding, smoke generation, and difficulty in maintaining a stable dissection plane.
Underwater ESD has emerged as a modified operative environment in which luminal insufflation is discontinued and the target segment is immersed in saline. Saline immersion may improve visualization of the submucosal layer and of submucosal vessels, limit smoke persistence in the operative field, and facilitate more stable dissection. Although initial retrospective and comparative experiences have suggested procedural advantages of underwater ESD, high-quality randomized comparative data remain limited, particularly in Western multicenter practice.
This study was therefore designed as a prospective multicenter randomized trial across Italian tertiary referral centers to compare underwater ESD with conventional gas-assisted ESD for colorectal neoplasia referred for ESD. Patients were allocated 1:1 to either UESD or GESD. The primary endpoint was en bloc resection. Secondary endpoints included R0 resection, procedural time, dissection speed, intraprocedural bleeding, need for hemostatic forceps, smoke interference, vessel visualization, cutting-plane visualization, post-procedural pain, post-ESD coagulation syndrome, perforation, and delayed bleeding. The technical conduct of ESD apart from the assigned luminal environment was left to expert operator discretion in order to preserve real-world tertiary-center practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Underwater Endoscopic Submucosal Dissection (UESD) | Experimental | Procedure: Underwater ESD (UESD)Underwater endoscopic submucosal dissection was performed after placement of the lesion on the anti-gravity side whenever feasible, discontinuation of luminal insufflation, and filling of the target colonic segment with saline solution to obtain stable immersion of the operative field. After immersion, mucosal incision and submucosal dissection were completed according to standard ESD principles, using either a conventional stepwise or tunnel-based strategy according to lesion characteristics and operator preference. Only saline solution was standardized across centers; device selection, generator settings, and ancillary maneuvers were otherwise left to operator discretion. Hemostasis, when required, was achieved using hemostatic forceps. |
| Conventional Gas-Assisted Endoscopic Submucosal Dissection (GESD) | Active comparator | Procedure: Conventional Gas-Assisted ESD (GESD)Conventional colorectal ESD was performed under gas insufflation according to standard practice at each participating center. Mucosal incision and submucosal dissection were carried out according to standard ESD technique. Device selection, generator settings, and technical dissection strategy were left to operator discretion. Hemostasis, when required, was achieved using hemostatic forceps. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 19 years or older
- Colorectal neoplastic lesion referred for endoscopic submucosal dissection
- Lesion considered amenable to en bloc endoscopic resection by ESD according to expert pre-procedural endoscopic assessment
- Written informed consent provided
Key exclusion criteria (5 listed)
- Known or suspected deep invasive neoplasia
- Inflammatory bowel disease
- Uninterrupted antithrombotic therapy
- Known coagulopathy
- Any clinical or lesion-related condition considered unsuitable for colorectal ESD by the treating endoscopist
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 (UESD)Underwater ESD (UESD) performed under saline immersion with luminal insufflation turned off. | Procedure or surgery | Underwater Endoscopic Submucosal Dissection (UESD) |
| Conventional Gas-Assisted ESD (GESD)Conventional colorectal ESD was performed under gas insufflation according to standard practice at each participating center. Mucosal incision and submucosal dissection were carried out according to standard ESD technique. Device selection, generator settings, and technical dissection strategy were left to operator discretion. Hemostasis, when required, was achieved using hemostatic forceps. | Procedure or surgery | Conventional Gas-Assisted Endoscopic Submucosal Dissection (GESD) |
Primary outcome
En bloc resection rate
Time frame: During the index procedure
Proportion of lesions resected in a single specimen.
12 secondary outcomes
R0 resection rate
Time frame: During index procedure and histopathological assessment within 30 days
Procedural time
Time frame: During the index procedure
Dissection speed
Time frame: During the index procedure
Intraprocedural bleeding rate
Time frame: During the index procedure
Use of hemostatic forceps
Time frame: During the index procedure
Smoke interference
Time frame: During the index procedure
Vessel visualization score
Time frame: Immediately after the index procedure
Cutting-plane visualization score
Time frame: Immediately after the index procedure
Post-procedural abdominal pain
Time frame: 15, 30, and 60 minutes after the procedure
Post-ESD coagulation syndrome (PECS)
Time frame: Within 7 days
Perforation rate
Time frame: From procedure to 30 days
Delayed bleeding rate
Time frame: From procedure to 30 days
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 31 Mar 2026.
- Individual participant dataSharing planned: Yes. Anonymsed data upon written and motivated requests
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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 (UESD) and Conventional Gas-Assisted ESD (GESD) in people with Colorectal Neoplasia and Colorectal Superficial Neoplasia, run by University of Roma La Sapienza 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 4 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 31 Mar 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?
En bloc resection rate (time frame: During the index procedure). 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 31 Mar 2026.