About this trial
For patients with locally advanced cholangiocarcinoma with resectable margins, patients who meet the selection criteria are randomly divided into two groups A and B. Group A: neoadjuvant PDT therapy combined with radical surgery; Group B: radical surgery. This study aims to explore the clinical effectiveness and safety of neoadjuvant photodynamic therapy for cholangiocarcinoma, as well as its role in destroying local tumors and enhancing systemic inflammation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with age between 18 to 75 years;
Patients'gender was not limited;
Patients with locally advanced cholangiocarcinoma who have a clear diagnosis of the primary disease and require surgical resection or potential surgical resection;
No history of radiotherapy and chemotherapy;
Disqualifiers
Women during pregnancy or breastfeeding, and those with mental illness;
Patients allergic to porphyrin drugs, porphyria;
Long-term use of glucocorticoids or autoimmune suppression;
Trial design
Parallel
Treatments tested in this trial
Neoadjuvant PDT + radical surgery
Procedure/SurgeryPatients with cholangiocarcinoma will undergo radical surgery after photodynamic therapy
Radical surgery
Procedure/SurgeryPatients with cholangiocarcinoma will only receive radical surgery
Treatment groups
Trial outcomes
Primary outcomes
R0 resection rate
Compare the incidence of positive margins of bile duct after surgical resection of cholangiocarcinoma between the two groups
Local recurrence rate
Compare the local recurrence rate of cholangiocarcinoma between the two groups
Survival time
Compare the 5-year survival time of the two groups
Secondary outcomes
Bilirubin level
Compare the Bilirubin level of the two groups
Complication rate
Compare the incidence of bile leakage, cholangitis, phototoxicity and other complications between the two groups
Tumor-free margin length
Compare the length of the tumor-free margin of the two groups of cholangiocarcinoma tissues
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: