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An exploratory study of the carcinopreventive effect of per-oral endoscopic myotomy and nifedipine combination in patients with esophageal motility disorders

An Open-Label, Open-Controlled, Exploratory Study to Evaluate the Efficacy of Combined Per-Oral Endoscopic Myotomy and Nifedipine in Preventing Esophageal Cancer in Patients with esophageal motility disorders

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031250002
Enrollment
15
Registered
2025-04-15
Start date
2025-05-07
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

esophageal motility disorder

Interventions

Nifedipine 10 mg CR tablets once daily for 30-60 days, followed by oral endoscopic myotomy

Sponsors

kobayashi Ryosuke
Lead Sponsor
Hirasawa Kingo
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Men and women between 18 and 90 years of age at the time of enrollment (2) Patients diagnosed with esophageal achalasia type I, II, III, EGJOO, Distal Esophageal Spasm, Hypercontractile Esophagus based on Chicago Classification v4.0 (3) Patients who give written consent to participate in this study

Exclusion criteria

Exclusion criteria: (1) Patients diagnosed with Absent Conractility, Ineffective Esophageal Motility among esophageal motility disorders (2) Patients with esophageal cancer (3) Patients with a history of hypersensitivity to nifedipine (4) Patients with Cre >2.0 (5) Patients with aortic stenosis, mitral stenosis, pulmonary hypertension, or congestive heart failure (6) Patients with systolic blood pressure less than 100 mmHg (7) Patients originally taking calcium blockers (8) Women who are pregnant, lactating, may become pregnant, or wish to become pregnant during the treatment period (9) Other patients who are judged to be inappropriate for the subject by the physician's judgment

Design outcomes

Primary

MeasureTime frame
p53 positivity in esophageal biopsy specimens before and after intervention

Secondary

MeasureTime frame
Improvement rate of p53 positive cells in esophageal biopsies at diagnosis and at POEM Improvement rate of Ki67 positive cells in esophageal biopsies at diagnosis and POEM Improvement rate of Ki67 positive cells at diagnosis and 60-120 days after POEM Percentage improvement in the number of Lugol voiding lesion at diagnosis and 60-120 days after POEM Percentage improvement in ecard score

Contacts

Public ContactDaisuke Azuma

Yokohama City University Medical Center

azuma.dai.av@yokohama-cu.ac.jp+81-45-261-5656

Outcome results

None listed

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