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Peranal endoscopic myectomy: prospective study

Efficacy and safety of peranal endoscopic myectomy for lower rectal tumors: phase II study

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1051240009
Enrollment
25
Registered
2024-04-12
Start date
2024-04-12
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Lower rectal cancer and lower rectal neuroendocrine tumor Rectal neoplasms

Interventions

None

Sponsors

Kanesaka Takashi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Technical success rate

Secondary

MeasureTime frame
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

Contacts

Public ContactTakashi Kanesaka

Department of Gastrointestinal Oncology, Osaka International Cancer Institute

takashikanesaka@gmail.com+81-6-6945-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026