High-power Green-light Laser Endoscopic Submucosal Dissection for Non-muscle-invasive Bladder Cancer

NCT05290623 | Completed

• 1 other identifier: SWYX:NO. 2022-085
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective study was designed in this study. The surgeon performed high-power green-light laser endoscopic submucosal dissection (HPL-ESD) for the treatment of primary non-muscle-invasive bladder cancer (NMIBC). This surgical treatment was novel and safety and efficacy of the treatment has not been established. We collected relative data in Shandong Provincial Hospital Affiliated to Shandong First Medical University from May 2018 to December 2020. Preoperative, intraoperative and postoperative clinical data were collected and analysed. The safety and efficacy of the novel surgical treatment were verified by the short-term and long-term clinical outcomes. Fifty patients with NMIBC were planed to be enrolled in the study.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Success rate of the surgery

  The success of the surgery was NMIBC got en bloc resection by HPL-ESD without transfering to other treatment. Success rate of the surgery is the proportion of surgery success in all surgery.

  after all data has been collected, analysis will be finished within 5 days

Secondary Outcomes (7)

• Rate of tumor en bloc resection

  after all data has been collected, analysis will be finished within 5 days

• Operative time

  after all data has been collected, analysis will be finished within 5 days

• Hemoglobin decrease

  after all data has been collected, analysis will be finished within 5 days

• Catheterization time

  after all data has been collected, analysis will be finished within 5 days

• Hospital stay

  after all data has been collected, analysis will be finished within 5 days

Eligibility Criteria

• Age: 20 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with primary non-muscle invasive bladder cancer that received high-power green laser submucosal resection will be enrolled in this study. Gender is not limited. Most patients were elder male people with smoking history.

You may qualify if:

• Patients with non-muscle invasive bladder cancer who received high-power green laser submucosal resection of bladder tumor

You may not qualify if:

• Patients with muscle invasive bladder cancer
• Patients with recurrent bladder cancer
• Patients with benign bladder tumor

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250000, China

Location

Related Publications (16)

• Xishuang S, Deyong Y, Xiangyu C, Tao J, Quanlin L, Hongwei G, Jibin Y, Dongjun W, Zhongzhou H, Jianbo W, Lina W, Lin Y. Comparing the safety and efficiency of conventional monopolar, plasmakinetic, and holmium laser transurethral resection of primary non-muscle invasive bladder cancer. J Endourol. 2010 Jan;24(1):69-73. doi: 10.1089/end.2009.0171.

  PMID: 19954353 BACKGROUND

• Zhu Y, Jiang X, Zhang J, Chen W, Shi B, Xu Z. Safety and efficacy of holmium laser resection for primary nonmuscle-invasive bladder cancer versus transurethral electroresection: single-center experience. Urology. 2008 Sep;72(3):608-12. doi: 10.1016/j.urology.2008.05.028. Epub 2008 Jul 23.

  PMID: 18649930 BACKGROUND

• Nagele U, Kugler M, Nicklas A, Merseburger AS, Walcher U, Mikuz G, Herrmann TR. Waterjet hydrodissection: first experiences and short-term outcomes of a novel approach to bladder tumor resection. World J Urol. 2011 Aug;29(4):423-7. doi: 10.1007/s00345-011-0653-8. Epub 2011 Feb 9.

  PMID: 21305303 BACKGROUND

• Herrmann TR, Wolters M, Kramer MW. Transurethral en bloc resection of nonmuscle invasive bladder cancer: trend or hype. Curr Opin Urol. 2017 Mar;27(2):182-190. doi: 10.1097/MOU.0000000000000377.

  PMID: 28033148 BACKGROUND

• Fried NM, Murray KE. High-power thulium fiber laser ablation of urinary tissues at 1.94 microm. J Endourol. 2005 Jan-Feb;19(1):25-31. doi: 10.1089/end.2005.19.25.

  PMID: 15735378 BACKGROUND

• He D, Fan J, Wu K, Wang X, Wu D, Li L, Li X, Liu L, Cao P, Cao J, Chang LS. Novel green-light KTP laser en bloc enucleation for nonmuscle-invasive bladder cancer: technique and initial clinical experience. J Endourol. 2014 Aug;28(8):975-9. doi: 10.1089/end.2013.0740. Epub 2014 May 19.

  PMID: 24735433 BACKGROUND

• Tao W, Yang D, Shan Y, Xue B, Sun C, Zang Y, Zhang Y. Safety and efficacy of 120W high performance system greenlight laser vaporization for non-muscle-invasive bladder cancer. J Xray Sci Technol. 2013;21(2):309-16. doi: 10.3233/XST-130379.

  PMID: 23694918 BACKGROUND

• Bai Y, Liu L, Yuan H, Li J, Tang Y, Pu C, Han P. Safety and efficacy of transurethral laser therapy for bladder cancer: a systematic review and meta-analysis. World J Surg Oncol. 2014 Sep 25;12:301. doi: 10.1186/1477-7819-12-301.

  PMID: 25256383 BACKGROUND

• Chen J, Zhao Y, Wang S, Jin X, Sun P, Zhang L, Wang M. Green-light laser en bloc resection for primary non-muscle-invasive bladder tumor versus transurethral electroresection: A prospective, nonrandomized two-center trial with 36-month follow-up. Lasers Surg Med. 2016 Nov;48(9):859-865. doi: 10.1002/lsm.22565. Epub 2016 Jul 25.

  PMID: 27454755 BACKGROUND

• Kramer MW, Rassweiler JJ, Klein J, Martov A, Baykov N, Lusuardi L, Janetschek G, Hurle R, Wolters M, Abbas M, von Klot CA, Leitenberger A, Riedl M, Nagele U, Merseburger AS, Kuczyk MA, Babjuk M, Herrmann TR. En bloc resection of urothelium carcinoma of the bladder (EBRUC): a European multicenter study to compare safety, efficacy, and outcome of laser and electrical en bloc transurethral resection of bladder tumor. World J Urol. 2015 Dec;33(12):1937-43. doi: 10.1007/s00345-015-1568-6. Epub 2015 Apr 25.

  PMID: 25910478 BACKGROUND

• Lingenfelder T, Fischer K, Sold MG, Post S, Enderle MD, Kaehler GF. Combination of water-jet dissection and needle-knife as a hybrid knife simplifies endoscopic submucosal dissection. Surg Endosc. 2009 Jul;23(7):1531-5. doi: 10.1007/s00464-009-0433-3. Epub 2009 Apr 3.

  PMID: 19343433 BACKGROUND

• Park JS, Youn YH, Park JJ, Kim JH, Park H. Clinical Outcomes of Endoscopic Submucosal Dissection for Superficial Esophageal Squamous Neoplasms. Clin Endosc. 2016 Mar;49(2):168-75. doi: 10.5946/ce.2015.080. Epub 2016 Feb 12.

  PMID: 26867548 BACKGROUND

• Cheng YY, Sun Y, Li J, Liang L, Zou TJ, Qu WX, Jiang YZ, Ren W, Du C, Du SK, Zhao WC. Transurethral endoscopic submucosal en bloc dissection for nonmuscle invasive bladder cancer: A comparison study of HybridKnife-assisted versus conventional dissection technique. J Cancer Res Ther. 2018;14(7):1606-1612. doi: 10.4103/jcrt.JCRT_786_17.

  PMID: 30589047 BACKGROUND

• Fritsche HM, Otto W, Eder F, Hofstadter F, Denzinger S, Chaussy CG, Stief C, Wieland WF, Burger M. Water-jet-aided transurethral dissection of urothelial carcinoma: a prospective clinical study. J Endourol. 2011 Oct;25(10):1599-603. doi: 10.1089/end.2011.0042. Epub 2011 Aug 4.

  PMID: 21815824 BACKGROUND

• Kaehler GF, Sold MG, Fischer K, Post S, Enderle M. Selective fluid cushion in the submucosal layer by water jet: advantage for endoscopic mucosal resection. Eur Surg Res. 2007;39(2):93-7. doi: 10.1159/000099597. Epub 2007 Feb 13.

  PMID: 17299266 BACKGROUND

• Xu Y, Guan W, Chen W, Xie C, Ouyang Y, Wu Y, Liu C. Comparing the treatment outcomes of potassium-titanyl-phosphate laser vaporization and transurethral electroresection for primary nonmuscle-invasive bladder cancer: A prospective, randomized study. Lasers Surg Med. 2015 Apr;47(4):306-11. doi: 10.1002/lsm.22342. Epub 2015 Apr 9.

  PMID: 25864416 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 22, 2022
• Study Start: May 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: March 18, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)