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Water-Assisted Versus Standard ESD for Large Nonpedunculated Colorectal Polyps: a Prospective Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Humanitas Research Hospital
RECRUITING
Rozzano
Contact Information
Primary
Ludovico Alfarone MD
ludovico.alfarone@humanitas.it
0282244377
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 122
Treatments
Active_comparator: Conventional 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
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Istituto Clinico Humanitas

This content was sourced from clinicaltrials.gov