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A study on the safety and efficacy of autologous platelet-rich plasma combined with occluders for the treatment of refractory upper gastrointestinal fistula

A study on the safety and efficacy of autologous platelet-rich plasma combined with occluders for the treatment of refractory upper gastrointestinal fistula

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064403
Enrollment
Unknown
Registered
2022-10-06
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

refractory upper gastrointestinal fistula

Interventions

Upper gastrointestinal fistula group:Autologous platelet-rich plasma endoscopic injection

Sponsors

Jiangsu Province Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-80 years who have been diagnosed with refractory upper gastrointestinal fistula: 1. No improvement after 3 months of fasting and nutritional support; 2. Patients who cannot tolerate surgical repair or whose repair is ineffective or who refuse surgery; 3. Patients unable to heal after endoscopic treatment; 4. Lack of effective treatment options.

Exclusion criteria

Exclusion criteria: 1. Coagulation dysfunction and bleeding disorders; 2. Serious cardiopulmonary diseases; 3. Cannot tolerate anesthesia; 4. In a state of pregnancy; 5. Acute stage of stroke; 6. Mental illness; 7. Patients who are unable to cooperate with treatment and follow-up; 8. History of postoperative radiotherapy and chemotherapy for esophageal cancer in the past two months; 9. Hb 2cm.

Design outcomes

Primary

MeasureTime frame
Complete blocking rate of fistula;Granulation coverage;

Secondary

MeasureTime frame
Fistula healing rate;Fistula healing time;Incidence of adverse events;Weight changes;Quality of life score;

Countries

China

Contacts

Public ContactZhang Guoxin

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

guoxinz@njmu.edu.cn+86 13951913128

Outcome results

None listed

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