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Status unknownNCT02951078Updated Nov 1, 2016

A Study of Comparing Effects of Thulium Laser en Bloc Resection and Electrical Transurethral Resection of the Non-muscle Invasive Bladder Cancer

A Phase 3 interventional study of Thulium Laser en Bloc Resection of bladder tumor and Electrical transurethral resection of bladder tumor in Bladder Cancer, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown. Open to male participants. Per ClinicalTrials.gov, last updated 2016-11-01.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
172
Allocation
Randomized
Sex
Male
01

Study summary

This study is to verify the short-term efficacy and long-term prognosis of thulium laser resection compared with conventional transurethral resection of non-muscular invasive bladder cancer. Half of participants will receive thulium laser resection of bladder cancer, while the other half will receive electrical transurethral resection of bladder cancer.

02

Conditions studied

  • Bladder Cancer
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 172 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  1. Pathological or histological diagnosis of primary non-muscle invasive bladder urothelial carcinoma (TaTisT1);
  2. Imaging examinations showed the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
  3. Patients who agree to TURBT surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation;
  4. Function of main organs (heart, liver, lung, kidney) should be normal, PS score 0-2;
  5. Bladder capacity≥ 200ml.

Exclusion criteria

Exclusion Criteria:

  1. Find distant metastasis ,infiltration of the surrounding organs or relapse before operation.Metastatic bladder cancer or other cancers involve the bladder;
  2. Received chemotherapy or BCG perfusion therapy in the nearly 3 months;
  3. Patients who can not tolerate the serious side effects during the bladder perfusion treatment process (bladder irritation and other symptoms);
  4. Patients during pregnancy ,critical care patients and patients who have other cases of surgical contraindications.Such as serious cardiovascular disease,coagulation abnormalities,non-transitional epithelial tumors( such as adenocarcinoma and squamous cell carcinoma),acute cystitis,can not be supine because of spinal deformity,untreated urethral stricture.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
172 participants (estimated)

Study arms

  • Experimental
    Thulium Laser en Bloc Resection of bladder tumor

    Thulium Laser en Bloc Resection of the Non-muscle Invasive Bladder tumor with thulium laser

    Procedure: Thulium Laser en Bloc Resection of bladder tumor

  • Active comparator
    Electrical transurethral resection of bladder tumor

    Electrical transurethral resection of the Non-muscle Invasive Bladder tumor

    Procedure: Electrical transurethral resection of bladder tumor

Interventions

  • ProcedureThulium Laser en Bloc Resection of bladder tumor
  • ProcedureElectrical transurethral resection of bladder tumor
06

What researchers measure

Primary outcomes

  1. The residual rate of tumor in the second operation of the two surgical methods

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02951078
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Liu Haitao (Chief physician, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Nov 1, 2016
Start date
Jan 2017
Primary completion
Dec 2018 (estimated)
Last update
Nov 1, 2016

Study contacts

Haitao Liu, chief physician
Contact
doctorlht69@163.com
+86 15301655608
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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