Clinical Research on the Assessment of Pathological Specimen Quality in Large Volume Non-Muscle-Invasive Bladder Cancer Surgery Using RECAP Technology

RECAPTURE: A Prospective Clinical Trial to Assess the Integrity and Quality of Pathological Specimens Obtained by the Representative En bloc-like Collection with Annotated Pieces (RECAP) Technique in Patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) with Tumors Larger Than 3 cm Undergoing En Bloc Resection

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500114247

Enrollment

Unknown

Registered

2025-12-09

Start date

2026-01-01

Completion date

Unknown

Last updated

2025-12-15

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

Conditions

Non-Muscle-Invasive Bladder Cancer (NMIBC)

Interventions

RCT Phase Control Group:conventional TURBT

RCT Phase Trial Group:Treatment with ERBT combined with RECAP

Pioneer Phase Trial Group:Treatment with ERBT combined with RECAP

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years, no gender restriction; 2. Unifocal or multifocal bladder cancer confirmed by imaging or cystoscopy, with at least one lesion larger than 3 cm in diameter; 3. No more than four lesions; 4. Clinical stage Ta/T1, with no evidence of muscle invasion; 5. ECOG score <=1; 6. No contraindications to surgery based on preoperative examination; 7. Patients who voluntarily participate in this trial, sign the informed consent form, and are willing to undergo follow-up.

Exclusion criteria

Exclusion criteria: 1.Urethral stricture, inability to insert ERBT or cTURBT surgical instruments via the urethra. 2.Presence of other incurable malignant tumors. 3.Acute urinary tract infection. 4.Patients with severe cardiopulmonary dysfunction or coagulation disorders, unable to tolerate anesthesia or surgery. 5.Poor compliance, unable to cooperate with follow-up treatment. 6.Patients who have undergone chemotherapy, radiotherapy, or immunotherapy. 7.Patients with severe bleeding disorders or coagulation abnormalities. 8.Pregnant or breastfeeding women.

Design outcomes

Primary

Measure	Time frame
Pathological specimen Integrity and Quality Score – Bladder Tumor (PIQS-BT) score;	—

Secondary

Measure	Time frame
Specimen collection time;Technical success rate;Intraoperative complication rate;Duration of indwelling urinary catheter;Progression-Free Survival (PFS);Recurrence rate;Overall Survival (OS);Rate of secondary (repeat) transurethral resection;Duration of continuous bladder irrigation;Postoperative adverse event rate;Postoperative hospital stay;operation time;	—

Countries

China

Contacts

Public ContactBoxin Xue

The Second Affiliated Hospital of Soochow University

18994392817@163.com+86 512 67784136

Outcome results

None listed

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