Patients with cervical cancer combined with vesico-vaginal fistula who are unable or failed to perform surgery
Conditions
Interventions
Group A:bilateral percutaneous nephrostomy
Group B:bilateral percutaneous nephrostomy and ureter occlusion stent placing
Group C:bilateral percutaneous nephrostomy and ureter occlusion stent placing combined uterine arterial embolization
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18-75 years(More than 18 years old and less than 75 years old); 2. Patient who were confirmed by gynecological examination, cystoscopy and pathological diagnosis as cervical carcinoma combined with vesico-vaginal fistula; 3. Patients who had previously undergone surgical repair but failed to cure it; 4. Patients who failed to choose surgical procedure because of bladder inflammation ,perineal inflammation or long term anti-inflammatory,but ineffective eczema; 5. Patient who are unable to undergo surgery or delayed surgery because of pelvic malignant tumor, the erosion of recurrent tuberculosis and radiation damage; 6. Patient who have surgical indications, but can not tolerate surgery within 3-6 months because of cardiopulmonary insufficiency,anemia,coagulation disorders,hemorrhage and cerebral infarction; 7. Patients whose ECOG physical condition score is within 0-1 points and the KPS score more than 60; 8. Patients with estimated survival time greater more than or equal to 3 months; 9. Patients whose function of important organs state can tolerate minimally invasive treatment; 10. Patients whose family members agreed to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients can be surgically repaired because of fresh traumatogenic fistulas (such as gynecologic surgical injury or injury) and confirmed vesico-vaginal fistula within 24 hours; 2. Patients with the fistula which was found early and small enough to be self-healed through the placement of catheter drainage; 3. Patients who has surgical indications for surgical repair and is scheduled to undergo elective surgery within three months after conservative treatment; 4. Patients who were unable to perform percutaneous nephrostomy for free kidney,horseshoe kidney and primary nephrotic disease; 5. Patients with hemorrhage history or bleeding events which reaches CTCAE 4.0 in 3 degrees or more four weeks before screening; 6. Patients with central nervous system metastasis or a history of central nervous system metastasis prior to screening; 7. Patients with severe diabetes and hematologic disorders (coagulation and coagulation disorders) and severe heart, lung, and liver dysfunction are unable to tolerate interventional treatment, And patients who are too weak to tolerate or are reluctant to undergo interventional therapy; 8. Patients with history of immunodeficiency and organ transplantation,or suffered from other acquired and congenital immunodeficiency disease; 9. Patients who have serious diseases that endanger the patient's safety or affect the completion the study according to the researchers' judgment; 10. Patients who refused long term bilateral percutaneous nephrostomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate;vesicovaginal fistula; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactXinwei Han
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed