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NCT06902701 | NOT YET RECRUITING | Rectal Neoplasms


Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia
Sponsor:

Turkish Society of Colon and Rectal Surgery

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.

Condition or disease

Rectal Neoplasms

Intervention/treatment

Endoscopic Submucosal Dissection (ESD)

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
Estimated Enrollment : 70 participants
Official Title : Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia: A Multicenter Prospective Observational Cohort Study
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2027-06-01
Estimated Study Completion Date : 2028-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)

Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia

Location Details

NCT06902701


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Locations


Not yet recruiting

Turkey,

Private Office

Istanbul, Turkey, 34394

Not yet recruiting

Turkey,

Basque University

Istanbul, Turkey,

Not yet recruiting

Turkey,

Memorial Sisli Hospital

Istanbul, Turkey,

Not yet recruiting

Turkey,

Nine September University

Izmir, Turkey, 35330

Not yet recruiting

Turkey,

Acibadem Kent Hospital

Izmir, Turkey,

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