Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia (ESTER)

Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia: A Multicenter Prospective Observational Cohort Study

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. Data will be collected from patients treated at multiple centers with expertise in ESD and TAMIS.

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Neoplasms
• Intervention / Treatment: Procedure: Endoscopic Submucosal Dissection (ESD); Procedure: Transanal Endoscopic Surgery (TES)

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 superficial lesions with high histological completeness but has a steep learning curve and a higher perforation risk. In contrast, TES, performed using transanal minimally invasive surgery (TAMIS) or transanal endoscopic operation (TEO), facilitates full-thickness excision and is more commonly used in Western surgical practice.

Each technique presents unique advantages and challenges. ESD is minimally invasive, preserves rectal function, and reduces postoperative complications such as fecal incontinence. However, its prolonged procedure time and technical difficulty limit its widespread adoption. TES, utilizing standard laparoscopic instruments, offers superior visualization and facilitates excision of deeper lesions but may lead to rectal wall defects, increased postoperative pain, and anorectal dysfunction. While studies suggest similar en bloc and recurrence rates between the two methods, discrepancies exist in procedural efficiency, hospital stay, and morbidity rates, with ESD potentially offering a shorter hospitalization period in certain cases.

Despite the increasing use of ESD and TES, a clear consensus on the optimal approach for early rectal neoplasms remains lacking. Existing data, primarily from high-volume centers in Asia, may not be fully applicable to Western populations. To address these gaps, this study aims to conduct a prospective, multi-center observational comparison of ESD and TES, assessing key outcomes such as recurrence rates, resection quality, complications, and hospital stay. The findings will contribute to refining treatment strategies and improving clinical decision-making for rectal neoplasm management.

• Study Type: Observational
• Enrollment (Estimated): 156

Contacts and Locations

• Study Contact: Name: Tayfun Bisgin, MD; Phone Number: +90-2324122901; Email: tayfun.bisgin@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Memorial Sisli Hospital
    • Contact: Email: ilknurerenler@hotmail.com
    • Principal Investigator: Ilknur Erenler Bayraktar, MD
    • Sub-Investigator: Onur Bayraktar, MD
  • Istanbul, Turkey
    • Baskent University
    • Contact: Feza Karakayali, MD; Phone Number: +90-5421454435; Email: fezaykar@yahoo.com
    • Principal Investigator: Feza Karakayali, MD
  • Istanbul, Turkey, 34394
    • Private Office
    • Contact: Cigdem Arslan, MD; Phone Number: +90-5421454435; Email: cigdemarslan@hotmail.it
    • Principal Investigator: Cigdem Arslan, MD
  • Izmir, Turkey, 35330
    • Dokuz Eylul University
    • Contact: Tayfun Bisgin, MD; Phone Number: +90-2324122901; Email: tayfun.bisgin@gmail.com
    • Principal Investigator: Tayfun Bisgin, MD
  • Izmir, Turkey
    • Acibadem Kent Hospital
    • Contact: Aras Emre Canda, MD; Phone Number: +90-5421454435; Email: candaae@gmail.com
    • Principal Investigator: Aras Emre Canda, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with rectal neoplasia undergoing treatment with either ESD or TES at participating centers. Patients will be assigned to ESD or TES based on physician preference, patient choice, and institutional availability.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic submucosal dissection (ESD); Patients who underwent excision with endoscopic submucosal dissection	Procedure: 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	Procedure: 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, ensuring full-thickness resection when necessary. The defect will be managed based on its size, with primary closure using absorbable sutures or left to heal by secondary intention. TEO will be conducted using a rigid transanal endoscopic platform with a stereoscopic optical system to enhance visualization. The lesion will be marked, and a full-thickness or submucosal excision will be performed using endoscopic instruments and electrosurgical devices. Post-resection, the rectal wall defect will be assessed, and primary closure will be performed when indicated to minimize post

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.

Collaborators and Investigators

• Sponsor: Turkish Society of Colon and Rectal Surgery
• Investigators: Study Chair: Feza Karakayali, MD, Baskent University

Publications and helpful links

General Publications

• de Sousa IVG, Bestetti AM, Cadena-Aguirre DP, Kum AST, Mega PF, da Silva PHVA, Miyajima NT, Bernardo WM, de Moura EGH. Comparison of endoscopic submucosal dissection and transanal endoscopic surgery for the treatment of rectal neoplasia: A systematic review and meta-analysis. Clinics (Sao Paulo). 2025 Mar 13;80:100613. doi: 10.1016/j.clinsp.2025.100613. eCollection 2025.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: March 16, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: endoscopic submucosal dissection; transanal endoscopic surgery; early rectal neoplasms
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: TKRCD2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There will be sharing of de-identified individual participant data (IPD) about both the primary and secondary outcomes.
• IPD Sharing Time Frame: The data will be available to qualified researchers upon reasonable request, starting 6 months after publication of the study results and for up to 5 years.
• IPD Sharing Access Criteria: Data will be shared via a secure data repository, and access will require an approved data-sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No