Underwater Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for the Treatment of Small Rectal Neuroendocrine Tumors

NCT07759960 | Recruiting

• 1 other identifier: NFEC-2026-079
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

Underwater endoscopic mucosal resection (UEMR) and endoscopic submucosal dissection (ESD) have both been reported to be two effective treatment methods for small rectal neuroendocrine tumor (NET). However, there is no consensus on the best method for the endoscopic resection of rectal NET. Therefore, we aimed to compare the efficacy and safety of UEMR and ESD for the treatment of small rectal NET.

Conditions

Rectal Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (1)

• histological complete resection

  complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins.

  within 14 days after procedure

Secondary Outcomes (8)

• success rate of operation

  intraoperative

• en bloc resection

  intraoperative

• operation time

  intraoperative

• complications

  within 14 days after procedure

• length of stay

  within 14 days after procedure

Study Arms (2)

UEMR group

EXPERIMENTAL

In UEMR group, enrolled patients will receive UEMR to remove small rectal NET.

Procedure: UEMR procedure

ESD group

ACTIVE COMPARATOR

In ESD group, enrolled patients will receive the standard treatment modality of ESD to remove small rectal NET

Procedure: ESD procedure

Interventions

UEMR procedure PROCEDURE

Small rectal NET will be removed by underwater endoscopic mucosal resection. The UEMR procedure included the following: (1) complete deflation of the colorectal lumen; (2) total immersion of the lesion in normal saline using a mechanical water pump; (3)needle injection of normal saline into the submucosa; (4) snaring the lesion and the surrounding mucosa; and (5) resection using electrocautery.

UEMR group

ESD procedure PROCEDURE

Small rectal NET will be removed by endoscopic submucosal dissection. The ESD procedure included the following: (1) dots were marked approximately 5 mm from the periphery of the lesion using coagulation; (2) a diluted sodium hyaluronate solution with indigo carmine dye was injected submucosally. (3) mucosal incision and submucosal dissection were performed using a T-Type ESD Knife (Micro-Tech, Nanjing, China) or Dual-knife (Olympus Medical, Tokyo, Japan); (4)after resection was completed, all visible vessels on the artificial wound were thoroughly coagulated to prevent postoperative bleeding.

ESD group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 75 years;
• With a high suspicion or evidence of rectal NET assessed using EUS, CT scan or colonoscopy;
• With tumor size ≤10 mm assessed by colonoscopy or EUS;
• Plan to receive UEMR or ESD treatment and provide written informed consent.

You may not qualify if:

• Unable to tolerate ESD or UEMR as assessed by the research team;
• Rectal NET with lymph node metastasis or distant metastasis;
• Received resection of rectal neuroendocrine tumor by other surgical procedures;
• Multiple rectal neuroendocrine tumors;
• Vulnerable groups such as pregnant women or patients with mental disorders;
• Poor compliance, unable to cooperate with treatment.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• The Eighth Affiliated Hospital of Southern Medical University: collaborator
• ZhuHai Hospital: collaborator
• Shenzhen Longgang District People's Hospital: collaborator
• Jiangmen Central Hospital: collaborator
• Yangjiang People's Hospital: collaborator
• The Third People's Hospital of Huizhou: collaborator
• the Fifth Affiliated Hospital of Zunyi Medical University (Zhuhai): collaborator
• Ganzhou City People's Hospital: collaborator

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Central Study Contacts

Zelong Han, MD

CONTACT

+86 20-6278-7385; hanzelong2025@163.com

Bitao Lin, MD

CONTACT

+86 137-2532-1385; linbitao1996@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 12, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)