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Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia (ESTER) 156 Observational
Clinical Trial NCT06902701 (ESTER) is an observational study for Rectal Neoplasms and is currently not yet recruiting. Enrollment is planned to begin on 1 July 2025 and continue until the study accrues 156 participants. Led by Turkish Society of Colon and Rectal Surgery, this study is expected to complete by 1 July 2028. The latest data from ClinicalTrials.gov was last updated on 24 June 2025.
Brief Summary
This prospective observational cohort study aims to compare the clinical and procedural outcomes of Endoscopic Submucosal Dissection (ESD) and Transanal Minimally Invasive Surgery (TAMIS) for the treatment of early-stage rectal neoplasia. The study will evaluate recurrence rates, en bloc resection rates, R0 resection rates, procedure time, complication rates, and length of hospital stay over a 1-year follow-up period...Show More
Detailed Description
Colorectal cancer (CRC) is one of the most common malignancies globally, with early-stage rectal neoplasms being increasingly diagnosed due to widespread screening programs. This trend has led to a greater focus on organ-preserving treatment options, with endoscopic submucosal dissection (ESD) and transanal endoscopic surgery (TES) emerging as key techniques for local excision. ESD allows for en bloc resection of sup...Show More
Official Title
Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia: A Multicenter Prospective Observational Cohort Study
Conditions
Rectal NeoplasmsPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- ESTER
- TKRCD2
NCT ID Number
Start Date (Actual)
2025-07-01
Last Update Posted
2025-06-24
Completion Date (Estimated)
2028-07-01
Enrollment (Estimated)
156
Study Type
Observational
Status
Not yet recruiting
Keywords
endoscopic submucosal dissection
transanal endoscopic surgery
early rectal neoplasms
transanal endoscopic surgery
early rectal neoplasms
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Endoscopic submucosal dissection (ESD) Patients who underwent excision with endoscopic submucosal dissection | Endoscopic Submucosal Dissection (ESD) Endoscopic excision of the rectal lesion by submucosal injection and circumferential mucosal incision using an electrosurgical knife with en-bloc resection intent |
Transanal endoscopic surgery (TES) Patients who underwent excision with transanal endoscopic surgery | Transanal Endoscopic Surgery (TES) Transanal endoscopic surgery procedures include Transanal Minimally Invasive Surgery (TAMIS) and Transanal Endoscopic Operation (TEO). TAMIS will be performed using a single-port transanal access platform with standard laparoscopic instruments, including a high-definition camera, an insufflation system, and endoscopic graspers. The lesion will be circumferentially excised using electrocautery or an energy device, ens...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
R0 Resection Rate | Proportion of patients with histologically confirmed tumor-free margins. All pathological evaluations will be performed according to the College of American Pathologists (CAP) protocol (version 4.3.0.0, 2023) | Immediately post-procedure. |
Recurrence Rate | Proportion of patients with tumor recurrence at follow-up endoscopy within 12 months, histologically confirmed from resected visible residual disease or, if absent, from scar biopsies. | 12 months post-procedure. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
En Bloc Resection Rate | Proportion of patients where the tumor was removed in a single piece. All pathological evaluations will be performed according to the College of American Pathologists (CAP) protocol (version 4.3.0.0, 2023) | Immediately post-procedure. |
Procedure Time | Total duration of the procedure (minutes). | Immediately post-procedure. |
Complication Rate | Incidence of adverse events, including all intraoperative and postoperative according to Clavien-Dindo classification. | Up to 30 days post-procedure. |
Length of Hospital Stay | Duration of hospitalization (days). | Perioperative/Periprocedural |
Fecal Incontinence | Patient-reported outcomes will be assessed using the Wexner Incontinence Score, a validated instrument that quantifies the frequency and severity of fecal incontinence. Scores range from 0 (perfect continence) to 20 (complete incontinence), with higher scores indicating greater dysfunction. | Pre-procedure and within the first 12 months post-procedure. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Adult patients (>18 years)
- Non-pedunculated (sessile) lesions larger than 2 cm.
- Lesions located within 15 cm from the anal verge confirmed by sigmoidoscopy or magnetic resonance imaging (MRI)
- Evidence of lymph node involvement, T2 rectal tumors, or distant metastasis on preoperative imaging modalities (MRI, ERUS, CT)
- Previous attempt at endoscopic resection
- Previous rectal surgery
- Previous pelvic radiation therapy
- Inflammatory bowel diseases (Crohn's disease, Ulcerative colitis)
Turkish Society of Colon and Rectal SurgeryStudy Central Contact
Contact: Tayfun Bisgin, MD, +90-2324122901, [email protected]
5 Study Locations in 1 Countries
Private Office, Istanbul, 34394, Turkey (Türkiye)
Cigdem Arslan, MD, Contact, +90-5421454435, [email protected]
Cigdem Arslan, MD, Principal Investigator
Baskent University, Istanbul, Turkey (Türkiye)
Feza Karakayali, MD, Contact, +90-5421454435, [email protected]
Feza Karakayali, MD, Principal Investigator
Memorial Sisli Hospital, Istanbul, Turkey (Türkiye)
Contact, [email protected]
Ilknur Erenler Bayraktar, MD, Principal Investigator
Onur Bayraktar, MD, Sub-Investigator
Dokuz Eylul University, Izmir, 35330, Turkey (Türkiye)
Tayfun Bisgin, MD, Contact, +90-2324122901, [email protected]
Tayfun Bisgin, MD, Principal Investigator
Acibadem Kent Hospital, Izmir, Turkey (Türkiye)
Aras Emre Canda, MD, Contact, +90-5421454435, [email protected]
Aras Emre Canda, MD, Principal Investigator