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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Unable to tolerate ESD or UEMR as assessed by the research team;

Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation;

Rectal NET with lymph node metastasis or distant metastasis;

Received resection of rectal neuroendocrine tumor by other surgical procedures;

Trial design

Design model

Parallel

Treatments tested in this trial

  • UEMR procedure

    Procedure/Surgery

    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.

  • ESD procedure

    Procedure/Surgery

    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.

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: UEMR groupExperimental treatment 1 intervention
Group B: ESD groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

histological complete resection

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

Time frame
within 14 days after procedure

Secondary outcomes

1

success rate of operation

the proportion of patients whose tumors were successfully resected in each group

Time frame
intraoperative
2

en bloc resection

complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined

Time frame
intraoperative
3

operation time

the time required to complete the procedure, was taken from the first submucosal injection to the end of complete resection of the targeted area or a failure or complication of the procedure which required discontinuation

Time frame
intraoperative
4

complications

perforation or hemorrhage during or after operation.

Time frame
within 14 days after procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

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