Traction-Assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors

NCT07848360 | Not Yet Recruiting

• 1 other identifier: 2607-035-165
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective, randomized pilot study will compare traction-assisted endoscopic submucosal dissection (T-ESD) with conventional endoscopic submucosal dissection (C-ESD) for the treatment of rectal neuroendocrine tumors. Patients with rectal neuroendocrine tumors generally measuring 15 mm or less, without suspected muscularis propria invasion, lymph node metastasis, or distant metastasis, who are considered suitable for endoscopic resection will be eligible for enrollment. Participants will be randomly assigned in a 1:1 ratio to undergo either T-ESD or C-ESD. In the T-ESD group, a traction device will be used during submucosal dissection to improve visualization of the submucosal layer, whereas conventional ESD will be performed without routine use of a traction device. The primary outcome is resection speed, calculated as the resected specimen area divided by the submucosal dissection time. Secondary outcomes include total procedure time, submucosal dissection time, en bloc and R0 resection rates, resection margin status, procedure-related adverse events, length of hospital stay, time to diet resumption, and unplanned emergency department visits or readmissions. The study is designed as an exploratory pilot trial to estimate the efficacy, safety, and variability of traction-assisted ESD and to provide preliminary data for the design of a future larger multicenter randomized trial.

Conditions

Rectal Neuroendocrine Tumor

Keywords

Rectal neuroendocrine tumor; Endoscopic submucosal dissection; Traction-assisted endoscopic submucosal dissection; Conventional endoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

• Resection speed

  Resection speed will be calculated as the resected specimen area (mm²) divided by the submucosal dissection time (min). The resected specimen area will be calculated using the ellipse formula: π × (major axis/2) × (minor axis/2). Submucosal dissection time will be measured from the start of submucosal dissection to complete resection of the lesion. The outcome will be expressed as mm²/min.

  During the ESD procedure, from the start of submucosal dissection to complete lesion resection

Secondary Outcomes (13)

• Total Procedure Time

  At completion of the ESD procedure

• Submucosal Dissection Time

  During the ESD procedure

• Traction Application Time

  During the ESD procedure

• En Bloc Resection Rate

  At completion of the ESD procedure

• R0 Resection Rate

  Postprocedurally, generally within 1 month after ESD

Study Arms (2)

Traction-Assisted Endoscopic Submucosal Dissection

EXPERIMENTAL

Participants assigned to this arm will undergo traction-assisted endoscopic submucosal dissection (T-ESD).

Procedure: Traction-Assisted Endoscopic Submucosal Dissection

Conventional Endoscopic Submucosal Dissection

ACTIVE COMPARATOR

Participants assigned to this arm will undergo conventional endoscopic submucosal dissection (C-ESD).

Procedure: Conventional Endoscopic Submucosal Dissection

Interventions

Traction-Assisted Endoscopic Submucosal Dissection PROCEDURE

After submucosal injection and mucosal incision, a standardized traction device will be applied to the lesion to provide traction and improve visualization of the submucosal layer.

Also known as: T-ESD, TA-ESD

Traction-Assisted Endoscopic Submucosal Dissection

Conventional Endoscopic Submucosal Dissection PROCEDURE

After submucosal injection, mucosal incision and submucosal dissection will be performed using conventional endoscopic submucosal dissection techniques without use of a traction device

Also known as: C-ESD

Conventional Endoscopic Submucosal Dissection

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older.
• Patients diagnosed with or strongly suspected of having a rectal neuroendocrine tumor on colonoscopy.
• Lesion size generally 15 mm or less, without suspected muscularis propria invasion on endoscopy and, when clinically indicated, endoscopic ultrasonography.
• No suspected lymph node metastasis or distant metastasis based on abdominal/pelvic imaging or clinical assessment.
• Lesions considered appropriate for endoscopic resection.
• Ability to understand the purpose and procedures of the study and provide written informed consent.

You may not qualify if:

• Suspected muscularis propria invasion, lymph node metastasis, or distant metastasis on endoscopy, endoscopic ultrasonography, imaging studies, or clinical assessment.
• Lesion size greater than 15 mm, or a lesion considered by the investigator to require surgical treatment rather than endoscopic resection.
• Conditions that make safe endoscopic submucosal dissection difficult, including inadequate bowel preparation.
• Uncontrolled bleeding tendency, severe thrombocytopenia, or uncorrectable coagulation disorder.
• Use of antiplatelet or anticoagulant therapy that cannot be appropriately discontinued or adjusted before the procedure.
• Severe cardiopulmonary disease, hepatic failure, renal failure, or other conditions considered to make sedation or endoscopic submucosal dissection unsafe.
• Pregnancy or breastfeeding.
• Inability to provide informed consent or impaired decision-making capacity.
• Altered anatomy of the rectum due to previous rectal surgery, radiotherapy, or other conditions that may interfere with standardization of the study procedure.
• Any other condition considered by the principal investigator or study investigator to make participation inappropriate.

Sponsors & Collaborators

• Pusan National University Hospital: lead

Related Publications (12)

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• Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.

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Central Study Contacts

Seung Min Hong, M.D., Ph.D.

CONTACT

+82-51-240-7869; lucky77i@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the primary study results and available for 5 years thereafter.
• Access Criteria: De-identified individual participant data may be provided to qualified researchers upon reasonable request, subject to review by the principal investigator and approval by the Institutional Review Board, when applicable.