NCT02760953

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of applying cryoablation as an adjuvant therapy with TUR to treat bladder tumor.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 19, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

April 22, 2016

Last Update Submit

October 17, 2017

Conditions

Urinary Bladder Neoplasms

Keywords

Bladder CancerCryoablation

Outcome Measures

Primary Outcomes (1)

  • Residual tumor rate

    The investigators would perform reTUR 4-6 weeks after initial surgery to detect residual tumor

    4-6 weeks after surgery

Secondary Outcomes (2)

  • Indwelling time

    One month after surgery

  • Adverse event rate

    Through study completion, an average of 2 year

Study Arms (2)

TUR with Cryoablation

EXPERIMENTAL

Patients received TUR to treat bladder cancer and immediate cryoablation was applied on the tumor bed in order to eliminate possible residual tumor. Two or three cycles of freeze could be give to fully cover the lesion. One cycle last three to five minutes base on our previous animal experiments.

Procedure: Cryoablation

TUR with instant instillation

ACTIVE COMPARATOR

Patients received TUR to treat bladder cancer and pirarubicin instillation was given within 24 hours after TUR. This is in accord with the current guideline.

Drug: Epirubicin

Interventions

CryoablationPROCEDURE

Using a novel cryoablation unit to perform transurethral cryoablation on the tumor base after transurethral resection

TUR with Cryoablation
EpirubicinDRUG

Epirubicin instillation should be give within 24 hours after initial TUR, this is accord with current guideline.

TUR with instant instillation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosed bladder tumor, stage T1 or T2
  • Number of lesions ≤ 3
  • Tumor size ≤ 3cm

You may not qualify if:

  • With other malignant diseases
  • T3 or above
  • Enlarged pelvic lymph node or distant metastasis
  • Poor overall condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Liu S, Zou L, Mao S, Zhang L, Xu H, Yang T, Jiang H, Ding Q. The safety and efficacy of bladder cryoablation in a beagle model by using a novel balloon cryoprobe. Cryobiology. 2016 Apr;72(2):157-60. doi: 10.1016/j.cryobiol.2016.02.007. Epub 2016 Mar 3.

    PMID: 26939677BACKGROUND

  • Hruby GW, Marruffo F, Ortiz J, Durak E, Edelstein A, Levi G, Landman J. Transurethral bladder cryoablation in the porcine model. Urology. 2007 Aug;70(2):391-5. doi: 10.1016/j.urology.2007.03.028.

    PMID: 17826526BACKGROUND

  • Xu C, Jiang S, Zou L, Sheng L, Shi G, Xu B, Wang Z, Xu D, Xie X, Luo J, Guo J, Jiang H. Endoscopic balloon cryoablation plus transurethral resection for bladder cancer: A phase 2, multicenter, randomized, controlled trial. Cancer. 2023 Feb 1;129(3):415-425. doi: 10.1002/cncr.34563. Epub 2022 Dec 7.

    PMID: 36477612DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

CryosurgeryEpirubicin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativeDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Haowen Jiang, Doctor

    Huashan Hospital

    STUDY DIRECTOR

Central Study Contacts

Shenghua Liu, Doctor

CONTACT

+86 021 52889999liushenghuafy@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 22, 2016

First Posted

May 4, 2016

Study Start

October 19, 2017

Primary Completion

October 30, 2018

Study Completion

December 31, 2018

Last Updated

October 19, 2017

Record last verified: 2017-10