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Protective effect of atorvastatin on esophageal stricture after endoscopic submucosal dissection (ESD): a prospective, randomized, controlled, multicenter study

Protective effect of atorvastatin on esophageal stricture after endoscopic submucosal dissection (ESD): a prospective, randomized, controlled, multicenter study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074081
Enrollment
Unknown
Registered
2023-07-28
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

Benign esophageal stricture

Interventions

Atorvastatin group:Atorvastatin was administered orally 20mg daily
Prednisone acetate group:Oral administration of prednisone acetate tablets (initial dose 30mg/day, gradually reduced after 2 weeks, with weekly doses of 30mg, 30mg, 25mg, 25mg, 20mg, 15mg, 10mg, and 5

Sponsors

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (i) aged 18 to 75 years old; (ii) diagnosed with early esophageal cancer or precancerous lesions requiring esophageal ESD surgery of more than two-thirds of the circumference; (iii) CT and other imaging examinations to exclude lymph node and distant metastases; (iv) agreed and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (i) Preoperative diagnosis of invasive esophageal cancer (tumor infiltration more than 200µm in the submucosal layer) or tumor recurrence; (ii) Allergy to one of atorvastatin, proton pump inhibitors, steroids or for other reasons can not be users; (iii) People who have had esophageal radiotherapy or surgery; (iv) Accompanied by other esophageal diseases (such as achalasia of cardia) that can cause the symptoms of dysphagia; (v) Accompanied by severe cardiac, pulmonary, hepatic and renal insufficiency; (vi) The following abnormal laboratory indexes exist: ALT/AST/creatine kinase/creatinine is higher than normal, platelet is lower than 80*10^9/L, APTT or PT prolongation is more than 3s; (vii) LDL<1.8mmol/L; (viii) Long-term use of drugs that may cause liver and kidney function damage; (ix) Long-term use of steroids or immunosuppressant; (x) Pregnancy or puerperium; (xi) Patients with mental diseases who are unable to take oral medication; (xii) Other conditions that are not suitable for ESD surgery or medication.

Design outcomes

Primary

MeasureTime frame
Occurrence stricture rate;Number of dilatations/incisions required;

Secondary

MeasureTime frame
Degree of dysphagia;Time that stricture occurred;Days between dilatations/incisions;

Countries

China

Contacts

Public ContactYaoyao Gong

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

ygong@njmu.edu.cn+86 136 2159 1027

Outcome results

None listed

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