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Traction-assisted endoscopic submucosal resection (TA-ESD)for small rectal neuroendocrine tumors: A randomized allocation-concealed open-label multi-center controlled trial

Traction-assisted endoscopic submucosal resection (TA-ESD)for small rectal neuroendocrine tumors: A randomized allocation-concealed open-label multi-center controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086769
Enrollment
Unknown
Registered
2024-07-10
Start date
2022-07-08
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal neuroendocrine tumor

Interventions

Traditional ESD:endoscopic submucosal resection
TA-ESD:Traction-assisted endoscopic submucosal resection (TA-ESD)

Sponsors

Shanghai sixth people's hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
38 Years to 76 Years

Inclusion criteria

Inclusion criteria: Age: 18-80 years old male/female small rectal neuroendocrine tumor <2cm Preoperative endoscopic ultrasound showed that the tumor was located in the submucosa, did not invade the muscularis propria, and no periintestinal enlarged lymph nodes were found. CT or MRI showed no periintestinal or peritoneal lymphadenopathy and no liver metastases The subjects agreed to undergo endoscopic treatment.

Exclusion criteria

Exclusion criteria: (1) Subject has malignant disease or severe cardiac disease (uncontrolled angina pectoris and/or myocardial infarction, congestive heart failure, etc.) in the 3 months prior to enrollment), lung (respiratory failure) or other diseases judged by the investigator to affect the follow-up evaluation of the study; (2) Subjects have abnormal platelets and coagulation, and have a greater risk of bleeding; (3) Patients who need to continue to use non-steroidal anti-inflammatory drugs, anticoagulants, antiplatelets or Chinese herbal medicine ingredients containing acetylsalicylic acid, ginkgo biloba, and echinacea, and cannot be discontinued due to primary diseases; (4) Preoperative contrast-enhanced CT and endoscopic ultrasound showed lymph node metastasis or distant metastasis around the tumor; (5) Subject is unable to cooperate with endoscopic operations.

Design outcomes

Primary

MeasureTime frame
Operation time;

Secondary

MeasureTime frame
En bloc resection rate;Histological complete resection(R0) rate;days of hospitalization;Complications;Use of antibiotics;

Countries

China

Contacts

Public ContactWan Xinjian

Shanghai sixth people's hospital

slwanxinjian2020@126.com+86 189 3017 3560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026