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

Turkish Society of Colon and Rectal Surgery

Status

Not yet enrolling

Conditions

Rectal Neoplasms

Treatments

Procedure: Transanal Endoscopic Surgery (TES)

Procedure: Endoscopic Submucosal Dissection (ESD)

Study type

Observational

Funder types

Other

Identifiers

NCT06902701

TKRCD2

Details and patient eligibility

About

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.

Full 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.

Enrollment

156 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)