Rectal NeoplasmsESTERNCT06902701
Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia
An observational study of Rectal Neoplasms, run by Turkish Society of Colon and Rectal Surgery at 5 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Endoscopic Submucosal Dissection (ESD) and Transanal Endoscopic Surgery (TES)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 156 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Jul 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Turkey (Türkiye)5 sites
Private Office
Istanbul, 34394
Cigdem Arslan, MD, +90-5421454435, cigdemarslan@hotmail.it
Cigdem Arslan, MD
Baskent University
Istanbul
Feza Karakayali, MD, +90-5421454435, fezaykar@yahoo.com
Feza Karakayali, MD
Memorial Sisli Hospital
Istanbul
ilknurerenler@hotmail.com
Ilknur Erenler Bayraktar, MD
Dokuz Eylul University
Izmir, 35330
Tayfun Bisgin, MD, +90-2324122901, tayfun.bisgin@gmail.com
Tayfun Bisgin, MD
Acibadem Kent Hospital
Izmir
Aras Emre Canda, MD, +90-5421454435, candaae@gmail.com
Aras Emre Canda, MD
About this study
Official title: Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia: A Multicenter Prospective Observational Cohort Study
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.
Read the 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
- Being tested
- Endoscopic Submucosal Dissection (ESD), Transanal Endoscopic Surgery (TES)
- Keywords
- endoscopic submucosal dissection, transanal endoscopic surgery, early rectal neoplasms
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Submucosal Dissection (ESD)Procedure or surgery
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)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic submucosal dissection (ESD) | Patients who underwent excision with endoscopic submucosal dissection Receives: Procedure: Endoscopic Submucosal Dissection (ESD) | |
| Transanal endoscopic surgery (TES) | Patients who underwent excision with transanal endoscopic surgery Receives: Procedure: Transanal Endoscopic Surgery (TES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 12 months post-procedure.
Secondary outcomes (5)
En Bloc Resection Rate
Proportion of patients where the tumor was removed in a single piece. All pathological evaluations will be performed according to the College of American Pathologists (CAP) protocol (version 4.3.0.0, 2023)
Measured: Immediately post-procedure.
Procedure Time
Total duration of the procedure (minutes).
Measured: Immediately post-procedure.
Complication Rate
Incidence of adverse events, including all intraoperative and postoperative according to Clavien-Dindo classification.
Measured: Up to 30 days post-procedure.
Length of Hospital Stay
Duration of hospitalization (days).
Measured: Perioperative/Periprocedural
Fecal Incontinence
Patient-reported outcomes will be assessed using the Wexner Incontinence Score, a validated instrument that quantifies the frequency and severity of fecal incontinence. Scores range from 0 (perfect continence) to 20 (complete incontinence), with higher scores indicating greater dysfunction.
Measured: Pre-procedure and within the first 12 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Turkish Society of Colon and Rectal Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feza Karakayali, MD, Study chair, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902701
- Sponsor's protocol ID
- TKRCD2
- Acronym
- ESTER
- Status last verified
- Jun 2025
- First submitted
- 16 Mar 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There will be sharing of de-identified individual participant data (IPD) about both the primary and secondary outcomes.
Publications
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.
PubMed 40086369
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Submucosal Dissection vs. Transanal Endoscopic Surgery for Rectal Neoplasia: A Multicenter Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06902701
- Acronym / sponsor ID
- ESTER / TKRCD2
- Conditions
- Rectal Neoplasms
- Keywords
- endoscopic submucosal dissection, transanal endoscopic surgery, early rectal neoplasms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Turkish Society of Colon and Rectal SurgeryUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic submucosal dissection (ESD) | – | Procedure: Endoscopic Submucosal Dissection (ESD)Patients who underwent excision with endoscopic submucosal dissection |
| Transanal endoscopic surgery (TES) | – | Procedure: Transanal Endoscopic Surgery (TES)Patients who underwent excision with transanal endoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Endoscopic submucosal dissection (ESD) |
| 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 | Procedure or surgery | Transanal endoscopic surgery (TES) |
Primary outcome
R0 Resection Rate
Time frame: Immediately post-procedure.
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)
Recurrence Rate
Time frame: 12 months post-procedure.
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.
5 secondary outcomes
En Bloc Resection Rate
Time frame: Immediately post-procedure.
Procedure Time
Time frame: Immediately post-procedure.
Complication Rate
Time frame: Up to 30 days post-procedure.
Length of Hospital Stay
Time frame: Perioperative/Periprocedural
Fecal Incontinence
Time frame: Pre-procedure and within the first 12 months post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 40086369de 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. There will be sharing of de-identified individual participant data (IPD) about both the primary and secondary outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feza Karakayali, MD study chair
Baskent University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms, run by Turkish Society of Colon and Rectal Surgery at 5 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tayfun Bisgin, MD (+90-2324122901, tayfun.bisgin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 Resection Rate (time frame: Immediately post-procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06902701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.