Comparative study of two endoscopic resection techniques (anchored snare-tip vs. precut endoscopic mucosal resection) for the treatment of rectal neuroendocrine turmos smaller than 10 mm in size

Comparison between anchored snare-tip vs. precut endoscopic mucosal resection for rectal neuroendocrine tumors smaller than 10 mm: a multicenter randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005148

Enrollment

Registered

2020-06-18

Start date

2020-11-17

Completion date

Unknown

Last updated

2022-11-28

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

Conditions

None listed

Interventions

Procedure/Surgery : The eligible population, who has an established or suspected rectal NET, will undergo one of two modified EMR techniques, precut EMR or anchored snare-tip EMR (ASEMR) in this study

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients who will undergo endoscopic treatment for an established or suspected rectal neuroendocrine tumor (NET) ? Patients with an age of 20 to 79 years ? Patients who provided informed consent for this study.

Exclusion criteria

Exclusion criteria: ? An established or suspected rectal NET larger than or equal to 10 mm in endoscopically measured size. ? A incompletely resected rectal NET after a previous therapeutic endoscopic interventio that requires endoscopic submucosal dissection, instead of EMR or modified EMR techniques. ? Without trying precut EMR or ASEMR (interventions for this study), endoscopic submucosal dissection was performed because of the inadequate lifting of the lesion after submucosal injection ? Platelet count less than 80,000/uL or Prolonged PT (over 50%) in the laboratory tests checked within 6 months before the intervention. ? Medical history of other known coagulopathy ? Patients who do not provide informed consent for this study ? Patients who do not show on the scheduled date for intervention and do not undergo the assigned intervention.

Design outcomes

Primary

Measure	Time frame
Histologic complete resection rate (per protocol analysis: only include rectal NETs in the final histologic report)	—

Secondary

Measure	Time frame
Procedure completion rate (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis);Resection time (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis);Procedure time including endoscopic hemostasis time (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis);Adverse event rate (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis)	—

Measure

Time frame

Procedure completion rate (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis);Resection time (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis);Procedure time including endoscopic hemostasis time (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis);Adverse event rate (intention-to-treat for all lesions / per protocol analysis for the lesions with NETs in the final diagnosis)

—

Countries

Korea, Republic of

Contacts

Public ContactDong-Hoon Yang

Asan Medical Center

gi.dr.yang@gmail.com+82-2-3010-5809

Outcome results