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Multi-center clinical study for photodynamic esophageal stent in the treatment of malignant esophageal obstruction

Multi-center clinical study for photodynamic esophageal stent in the treatment of malignant esophageal obstruction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026824
Enrollment
Unknown
Registered
2019-10-23
Start date
2019-11-30
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

Esophageal cancer, malignant obstruction

Interventions

Control group:Regular stent
Experimental group:photodynamic stent + 3 photodynamic therapy

Sponsors

Shanghai Sixth People's Hospital East Campus
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: The pathology was clearly diagnosed as a patient with advanced esophageal malignant obstruction, a patient with moderate to severe dysphagia symptoms, and those who were unwilling to undergo surgery or were unable to undergo surgery. 1. must meet the indications for surgery without contraindications; 2. The site of malignant esophageal obstruction is the middle and lower segment; 3. degree of esophageal stenosis: dysphagia score =50%.

Exclusion criteria

Exclusion criteria: 1. Surgical contraindications; 2. The esophageal malignant obstruction occurs in the upper part 3. degree of esophageal stenosis: dysphagia score > 6 points, Pincus score > 2 points, endoscopic stenosis grade III-IV, esophagography: stenosis rate < 50%. 4. The patient refused to receive the stent treatment.

Design outcomes

Primary

MeasureTime frame
Symptom improvement;Lumen loss rate (restenosis rate);

Secondary

MeasureTime frame
Tissue regeneration, esophageal patency rate, stent displacement and detachment on the inner surface of the stent;Dysphagia score;

Contacts

Public ContactYing-sheng Cheng

Shanghai Sixth People's Hospital East Campus

chengyingsheng@hotmail.com+86 18917683588

Outcome results

None listed

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