Bladder Cancer
Conditions
Interventions
ESD-like specimen handling protocol Group:None
Sponsors
Liuzhou people's hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: >=18 years. 2. Diagnosis/Clinical suspicion: Patients with bladder tumors identified by cystoscopy and/or imaging who are scheduled to undergo transurethral resection of bladder tumor and are considered suitable for en bloc resection of bladder tumor (ERBT) based on the preoperative assessment. 3. Preoperative staging: Imaging and cystoscopic evaluation do not clearly indicate full-thickness invasion of the bladder wall. 4. Preoperative staging: Imaging and cystoscopic evaluation do not clearly indicate muscle-invasive disease, or muscle invasion is suspected but ERBT is considered feasible to achieve maximal tumor removal and/or obtain a high-quality pathological specimen. 5. Surgical eligibility: Patients are considered fit for surgery and anesthesia based on the preoperative anesthetic evaluation (e.g., American Society of Anesthesiologists [ASA] Physical Status I–III, or according to institutional anesthesia assessment). 6. Preoperative assessment: Completion of routine preoperative evaluations for transurethral surgery at our institution, including laboratory examinations (e.g., complete blood count, coagulation profile, and renal function) meeting the institutional criteria for surgery. 7. Follow-up feasibility: Patients are expected to complete at least 12 months of follow-up, including cystoscopic surveillance, urinary tract ultrasonography, and/or telephone follow-up. 8. Informed consent: Written informed consent is voluntarily provided by the patient or the patient’s legally authorized representative. 9. Suspected high-risk or high-complexity bladder tumors, defined by the presence of at least one of the following criteria: * (1) Three or more bladder tumors; * (2) Maximum tumor diameter =3 cm with a broad-based lesion and/or satellite lesions; * (3) Fewer than three tumors with a maximum diameter <3 cm, but exhibiting a broad-based or nodular growth pattern.
Exclusion criteria
Exclusion criteria: 1. Tumor characteristics unsuitable for ERBT: Bladder neck tumors, tumors adjacent to the bladder neck, or extensive bladder tumors for which en bloc resection of bladder tumor (ERBT) is considered technically infeasible. 2. Concurrent urothelial malignancies: Presence of synchronous upper urinary tract urothelial carcinoma or urethral tumors requiring simultaneous treatment. 3. Previous bladder treatment affecting pathological evaluation: History of bladder radiotherapy resulting in severe bladder contracture, or extensive transurethral cauterization/resection within the previous 3 months leading to significant scarring that is expected to interfere with specimen orientation or pathological assessment. 4. Excessive surgical risk due to coagulation disorders or anticoagulation therapy: Severe thrombocytopenia, markedly abnormal coagulation parameters (e.g., elevated international normalized ratio [INR]), or inability to discontinue anticoagulant and/or antiplatelet therapy according to current guidelines, rendering the patient unsuitable for surgery as determined by the anesthesiologist or surgeon. 5. Severe comorbidities precluding transurethral surgery: Patients who are unable to tolerate anesthesia or are considered to have an unacceptably high perioperative risk based on the anesthesiologist’s assessment. 6. Pregnancy or lactation. 7. Investigator’s discretion: Any condition that, in the opinion of the investigator, may compromise patient safety, study quality, or the evaluation of the primary study endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous assessability of the deep (vertical) resection margin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Consistency of re-evaluation for deep pathological indicators;Evaluability rate of the circumferential (horizontal) resection margin;T1 Substaging;Rate of definitive T-staging determination;Perioperative complications;Thermal Injury Score;Detectability and evaluability rate of the muscularis propria;Recurrence-Free Survival (RFS); | — |
Countries
China
Contacts
Public ContactWeimin Zhou
Liuzhou people's hospital
Outcome results
None listed