Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia

NCT ID: NCT06902701

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 156 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2028-07-01

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.

Conditions

Rectal Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endoscopic submucosal dissection (ESD)

Patients who underwent excision with endoscopic submucosal dissection

Endoscopic Submucosal Dissection (ESD)

Intervention Type: PROCEDURE

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

Transanal Endoscopic Surgery (TES)

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turkish Society of Colon and Rectal Surgery

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Feza Karakayali, MD

Role: STUDY_CHAIR

Baskent University

Locations

Private Office

Istanbul, , Turkey (Türkiye)

Baskent University

Istanbul, , Turkey (Türkiye)

Memorial Sisli Hospital

Istanbul, , Turkey (Türkiye)

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Acibadem Kent Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Tayfun Bisgin, MD

Role: CONTACT

tayfun.bisgin@gmail.com

+90-2324122901

Facility Contacts

Cigdem Arslan, MD

Role: primary

cigdemarslan@hotmail.it

+90-5421454435

Feza Karakayali, MD

Role: primary

fezaykar@yahoo.com

+90-5421454435

Role: primary

ilknurerenler@hotmail.com

Tayfun Bisgin, MD

Role: primary

tayfun.bisgin@gmail.com

+90-2324122901

Aras Emre Canda, MD

Role: primary

candaae@gmail.com

+90-5421454435

References

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.

Reference Type: BACKGROUND

PMID: 40086369 (View on PubMed)

Related Links

https://arastirma.tkrcd.org.tr

Related Info

Other Identifiers

TKRCD2

Identifier Type: -

Identifier Source: org_study_id