Clinical trial NCT06902701: Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia
Official title: Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia: A Multicenter Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rectal Neoplasms
Keywords: endoscopic submucosal dissection
transanal endoscopic surgery
early rectal neoplasms
Lead sponsor: Turkish Society of Colon and Rectal Surgery
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: R0 Resection Rate
timeFrame: Immediately post-procedure.
measure: Recurrence Rate
timeFrame: 12 months post-procedure.
Secondary outcomes:
measure: En Bloc Resection Rate
timeFrame: Immediately post-procedure.
measure: Procedure Time
timeFrame: Immediately post-procedure.
measure: Complication Rate
timeFrame: Up to 30 days post-procedure.
measure: Length of Hospital Stay
timeFrame: Perioperative/Periprocedural
measure: Health-related quality of life
timeFrame: 1-year
measure: Fecal Incontinence-related quality of life
timeFrame: 1-year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Private Office
city: Istanbul
country: Turkey
facility: Baskent University
city: Istanbul
country: Turkey
facility: Memorial Sisli Hospital
city: Izmir
country: Turkey
facility: Dokuz Eylul University
city: Izmir
country: Turkey
facility: Acibadem Kent Hospital
Study officials:
affiliation: Baskent University
name: Feza Karakayali, MD
role: STUDY_CHAIR
References:
citation: 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.