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A randomized, controlled, multicenter study on the safety and efficacy of segmented esophageal flexible stent in the treatment of malignant esophageal obstruction

A randomized, controlled, multicenter study on the safety and efficacy of segmented esophageal flexible stent in the treatment of malignant esophageal obstruction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034249
Enrollment
Unknown
Registered
2020-06-29
Start date
2020-06-30
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

Esophageal cancer

Interventions

experimental group:Segmented flexible esophageal stent placement
control group:Common covered esophageal stent placement

Sponsors

Shanghai Tongren Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Patients with progressive dysphagia and dysphagia index of grade III or IV; 2. Patients with primary malignant tumor confirmed by pathological biopsy or more than two kinds of imaging diagnosis; 3. Esophagography: the lesion segment was obviously narrow, the passage of contrast medium was blocked, and the upper part of the lesion was dilated; 4. CT three-dimensional reconstruction of esophageal lesions to show the volume and morphological characteristics of lesions; 5. The ECoG score of the patients ranged from 0 to 3, and they were conscious enough to cooperate with the operation; 6. Patients and their family members informed consent and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. The patients whose lesion position is too high and whose upper edge is higher than the level of C7; 2. Patients with esophageal ulcer, esophagotracheal fistula or esophageal mediastinal fistula; 3. Patients with severe liver and kidney dysfunction or abnormal test indexes that cannot be corrected.

Design outcomes

Primary

MeasureTime frame
Dysphagia score and grade;Endoscopic stenosis classification;Pincus score;Esophagography;

Countries

China

Contacts

Public ContactMao Aiwu

Shanghai Tongren Hospital

13701814247@163.com+86 13701814247

Outcome results

None listed

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