The Difference of Two Year Recurrence Rate According to Anesthetic Method During Transurethral Resection of Bladder Mass in Patients With Non-muscle Invasive Bladder Cancer: Prospective, Randomized, Clinical Phase II Study

NCT03597087 | Unknown DMC

• 1 other identifier: SeoulNUH_2018_TURBT
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators compare the recurrence rate difference between two years after transurethral resection of the bladder tumor according to the method of anesthesia. Anesthetic methods are general anesthesia and spinal anesthesia. Assessment of recurrence is assessed by bladder endoscopy, CT, and pathological examination of surgical specimens.

Conditions

Bladder Cancer

Keywords

Anesthesia, Bladder cancer, Recurrence rate, Transurethral resection of bladder mass

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence-free survival rate

  The criteria for recurrence-free survival and recurrence of bladder cancer for 2 years postoperatively are based on pathological histology. If the recurrence is suspected in the radiological examination but pathological histological examination is difficult, the reference is based on the day of the imaging examination suspected of recurrence.

  Follow up every 3 months until 2 years after surgery

Secondary Outcomes (1)

• 2-year progression-free survival

  Follow up every 3 months until 2 years after surgery

Study Arms (2)

General anesthesia

EXPERIMENTAL

Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol

Procedure: Anesthesia before transurethral resection of the bladder tumor; Drug: Anesthesia

Spinal anesthesia

EXPERIMENTAL

Group of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine

Procedure: Anesthesia before transurethral resection of the bladder tumor; Drug: Anesthesia

Interventions

Anesthesia before transurethral resection of the bladder tumor PROCEDURE

General anaesthesia or general anesthesia (see spelling differences) is a medically induced coma with loss of protective reflexes, resulting from the administration of one or more general anaesthetic agents. Spinal anaesthesia is a form of regional anaesthesia involving the injection of a local anaesthetic into the subarachnoid space, generally through a fine needle

General anesthesia; Spinal anesthesia

Anesthesia DRUG

General anaesthesia : propopol Spinal anaesthesia : bupibacaine

General anesthesia; Spinal anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• Patients with suspected Ta / T1 non-muscle invasive bladder cancer
• Patients who were not previously treated with other cancers
• Normal range creatinine, AST, ALT patients
• Patients with both spinal anesthesia and general anesthesia

You may not qualify if:

• Patients with urinary tract carcinoma not invading the renal pelvis, ureter or urethra
• Patients with cancer other than bladder cancer or a history of treatment
• Patients with clinical evidence of muscle-invasive bladder cancer
• Patients taking immunosuppressive drugs and immunosuppressive drugs

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (24)

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• Han JH, Yuk HD, Jeong SH, Jeong CW, Kwak C, Kim JT, Ku JH. Anesthetic approaches and 2-year recurrence rates in non-muscle invasive bladder cancer: a randomized clinical trial. Reg Anesth Pain Med. 2024 Dec 31:rapm-2024-105949. doi: 10.1136/rapm-2024-105949. Online ahead of print.

  PMID: 39740955 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Jin Tae Kim, PhD

  Professor, Department of Anesthesiology, Seoul National University Hospital

  STUDY DIRECTOR

• Ja Hyeon Ku, PhD

  Professor, Department of Urology, Seoul National University Hospital

  STUDY CHAIR

• Hyeong Dong Yuk, MD

  Clinical fellow, Department of Urology, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Song Hee Kim, Bacheolor

  Researcher, Department of Urology, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Jae Hyun Jung, MD

  Clinical fellow, Department of Urology, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Jung Hoon Lee, MD

  Clinical fellow, Department of Urology, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyeong Dong Yuk, MD

CONTACT

+82-2-2072-1968; hinayuk@naver.com

Song Hee Kim, Bacheolo

CONTACT

+82-2-2072-1968; songheekim0506@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Using a web site, and creating a randomized list at Sealedenvalop.com. Patients are randomly assigned to receive an anesthetic consent, and no masking is performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD., PHD.

Model Details: After randomization, they were divided into two parallel groups 289 patients were randomly assigned to a spinal anesthesia group and a general anesthesia group 1: 1.

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 24, 2018
• Study Start: July 19, 2018
• Primary Completion: July 1, 2021
• Study Completion: December 31, 2022
• Last Updated: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)