Peranal endoscopic myectomy: prospective study

JRCT ID: jRCT1051240009

Registered date:12/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lower rectal cancer and lower rectal neuroendocrine tumor
• Date of first enrollment: 12/04/2024
• Target sample size: 25
• Study type: Observational
• Intervention(s): None

Outcome(s)

• Primary Outcome: Technical success rate

Secondary Outcome

1. Procedure time
2. En bloc resection rate
3. R0 resection rate
4. Incidence of adverse events, e.g. bleeding, perforation.
5. Degree of defecation dysfunction

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

Patients are eligible if they meet all of #3 to #7 in addition to #1 or #2 below.
1. Patients diagnosed with cT1 lower rectal cancer or lower rectal neuroendocrine tumor (endoscopic diagnosis is acceptable for rectal cancer diagnosis).
2. Patients who underwent endoscopic resection for lower rectal cancer or lower rectal neuroendocrine tumor, and the vertical margin was diagnosed as positive or unclear based on pathological diagnosis of the resected specimen.
3. Endoscopic evaluation shows that the oral end of the lesion is located in Rb.
4. Patients requesting endoscopic resection for the above lesions.
5. Patients who are 18 years or older at the time of registration.
6 Patients whose performance status is 0-1 according to ECOG standards.
7. Patients who have given written consent to participate in the study.

Exclude criteria

Patients are excluded if any of the following.
1. Patients suspected of lymph node metastasis or distant metastasis on chest and abdominal CT examination.
2. Patients with liver cirrhosis, renal failure, heart failure, or blood disorders.
3. Patients who are judged to be inappropriate as subjects by the researcher.

Related Information

• Primary Sponsor: Kanesaka Takashi