Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia

NCT06902701 | Not Yet Recruiting

• 1 other identifier: TKRCD2
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 5

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

Conditions

Rectal Neoplasms

Keywords

endoscopic submucosal dissection; transanal endoscopic surgery; early rectal neoplasms

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (5)

• En Bloc Resection Rate

  Immediately post-procedure.

• Procedure Time

  Immediately post-procedure.

• Complication Rate

  Up to 30 days post-procedure.

• Length of Hospital Stay

  Perioperative/Periprocedural

• Fecal Incontinence

  Pre-procedure and within the first 12 months post-procedure.

Study Arms (2)

Endoscopic submucosal dissection (ESD)

Patients who underwent excision with endoscopic submucosal dissection

Procedure: Endoscopic Submucosal Dissection (ESD)

Transanal endoscopic surgery (TES)

Patients who underwent excision with transanal endoscopic surgery

Procedure: Transanal Endoscopic Surgery (TES)

Interventions

Endoscopic Submucosal Dissection (ESD) PROCEDURE

Endoscopic excision of the rectal lesion by submucosal injection and circumferential mucosal incision using an electrosurgical knife with en-bloc resection intent

Endoscopic submucosal dissection (ESD)

Transanal Endoscopic Surgery (TES) PROCEDURE

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

Transanal endoscopic surgery (TES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Turkish Society of Colon and Rectal Surgery: lead

Study Sites (5)

Private Office

Istanbul, 34394, Turkey (Türkiye)

Location

Baskent University

Istanbul, Turkey (Türkiye)

Location

Memorial Sisli Hospital

Istanbul, Turkey (Türkiye)

Location

Dokuz Eylul University

Izmir, 35330, Turkey (Türkiye)

Location

Acibadem Kent Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40086369 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Endoscopic Mucosal Resection; Transanal Endoscopic Surgery

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Natural Orifice Endoscopic Surgery; Proctoscopy

Study Officials

• Feza Karakayali, MD

  Baskent University

  STUDY CHAIR

Central Study Contacts

Tayfun Bisgin, MD

CONTACT

+90-2324122901; tayfun.bisgin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 30, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• Access Criteria: Data will be shared via a secure data repository, and access will require an approved data-sharing agreement.

Locations

TU (5)