Bladder CancerNCT05290623
High-power Green-light Laser Endoscopic Submucosal Dissection for Non-muscle-invasive Bladder Cancer
An observational study of Bladder Cancer, run by Shandong Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 88 years
- Conditions the study is for
- Bladder Cancer
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 18 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with non-muscle invasive bladder cancer who received high-power green laser submucosal resection of bladder tumor
Who cannot join
- Patients with muscle invasive bladder cancer
- Patients with recurrent bladder cancer
- Patients with benign bladder tumor
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000
About this study
Official title: High-power Green-light Laser Endoscopic Submucosal Dissection for Non-muscle-invasive Bladder Cancer: a Technical Improvement and Its Initial Application
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.
Read the detailed description
Background: In recent years, endoscopic laser surgery has been introduced to the treatment of NMIBC. Various types of laser (holmium laser, thulium laser and green-light laser) have been examined in the treatment of NMIBC, and the cutting power has been raised gradually. In our previous study, a 120 W green-light laser was used to perform en bloc resection, which yielded encouraging results. Endoscopic submucosal dissection by the HybridKnife was reported to be safe and effective in the treatment of NMIBC. However, previous resection was performed by electrical instrument. To further enhance the safety and accuracy of the operation, surgeons improved the treatment by combining laser resection and endoscopic submucosal dissection (ESD). This novel surgical treatment can also integrate advantages of each method. A retrospective study was designed in this study. The aim of the study was to evaluate the safety and efficacy of this novel surgical treatment, high-power green-light laser endoscopic submucosal dissection (HPL-ESD), in the treatment of primary non-muscle-invasive bladder cancer (NMIBC).
Introduction: Greenlight lasers are developed from Nd:YAG laser. Visual laser vaporization with Nd:YAG laser was introduced for the treatment of bladder cancer in the early 1990s. However, the low-absorption in most tissues with a penetration depth of 4-18mm leading to a deep coagulative necrosis of tissue, which increased the risk of delayed bladder perforation and bowel injury. Passing the Nd:YAG-produced beam (1046nm) through a KTP or LBO crystal, leads to a green visible light beam of 532nm, which has a completely different laser beam-tissue interaction. The wavelength is not absorbed by water but strongly absorbed by hemoglobin, which limits the optical penetration depth of green light laser to 0.8 mm, and the heat remaining in the tissue induces a coagulation zone of only 1-2mm thickness. Recent studies show that greenlight laser vaporization is a reliable and feasible treatment for the patients with primary NMIBC compared with standard TURBT.
On the basis of our previous surgical procedure, we developed this new surgical method by introducing ESD technology. Thus LBO laser en bloc resection was combined with the ESD technique to treat NMIBC, which was inspired by waterjet-assisted ESD in the department of gastroenterology. ESD was developed from endoscopic mucosal resection (EMR) and widely applied for the treatment of early gastroesophageal cancer and colorectal neoplasms. The bladder wall shares a similar histological structure with the gastrointestinal tract, although the muscularis propria is thicker. Therefore, forming a submucosal fluid cushion in the bladder wall should be feasible and even safer. The effects of submucosal fluid cushion on bladder wall were showed intuitively. The interspace between the mucosal layer and the detrusor muscle layer was increased, and the tissue between the two layers was rendered looser. In the present study, the submucosal fluid cushion increases safety during the operation. More importantly, when the normal mucosa was incised, the detrusor muscle layer beneath was exposed, which facilitated distinction of which layer was reached and incision of the entire tumor with the superficial detrusor muscle beneath the basal part. To some extent, introduction of the ESD technique enabled safe, controllable and accurate incision.
Equipment: The equipment included a 23F continuous flow resectoscope through which a 6F green-light lithium triborate (LBO) laser fiber (Realton, Beijing, China) could be delivered via the working channel. In addition, a disposable injector was used to form the submucosal fluid cushion for ESD. The stainless steel needle of the injector is 5 mm in length and 0.6 mm in diameter (terminal part). The working length and diameter are 1650 mm and 2.5 mm respectively (middle part), enabling delivery through the working channel of the resectoscope. The beginning part of the injector was connected to a 20-ml syringe containing methylene blue solution as the injection fluid.
HPL-ESD procedure: All surgeries were conducted in the lithotomy position under continuous epidural anesthesia. Sodium chloride physiological solution was used for irrigation. The 23F continuous flow resectoscope was delivered into the bladder through the urethra initially. Each visible tumor was examined to confirm the location, number, and size and the condition of the adjacent mucosa. Then, the 6F green-light LBO laser fiber was delivered through the working channel of the resectoscope. Each tumor was first marked with a circular coagulation blockage border, which was 1-2 cm from the edge of the tumor. Next, the laser fiber was temporarily withdrawn and the disposable injector was delivered through the same working channel of the resectoscope. Multipoint injection was performed in the normal mucosa along the blockage border. Because the tissue between the mucosal layer and the detrusor muscle layer in the bladder wall is relatively loose, a blue submucosal fluid cushion was formed between the two layers after injection. Subsequently, the green-light laser was delivered through the working channel again. The laser power was set at 160 W for cutting and 30-50 W for coagulation simultaneously. The mucosa was incised annularly, and the detrusor muscle layer beneath it was gradually exposed. The submucosal fluid cushion separated the mucosa layer and the detrusor muscle layer to some extent in advance. Therefore, the course and distribution of the detrusor muscle could be clearly observed. Dissection of tissue connected between the tumor and the bladder wall was also facilitated. The entire tumor was excised with superficial detrusor muscle beneath the basal part. After resection, the whole tumor bed and surrounding mucosa were carefully coagulated at a power of 30-50 W. The intact bladder tumor was removed with an alligator forceps or flushed out with an Ellik evacuator. When the tumor size was > 3 cm, the specimen was longitudinally cut into two or more parts.
Clinical data will be collected, such as patient data, tumor characteristics, and perioperative data.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after all data has been collected, analysis will be finished within 5 days
Secondary outcomes (7)
Rate of tumor en bloc resection
The proportion of tumor en bloc resection (R0 resection) in all resected tumors.
Measured: after all data has been collected, analysis will be finished within 5 days
Operative time
The time from the installation of endoscopic instrument to the complete resection of bladder tumor
Measured: after all data has been collected, analysis will be finished within 5 days
Hemoglobin decrease
Hemoglobin decrease (g/dL) = preoperative serum hemoglobin (g/dL) - postoperative serum hemoglobin (g/dL)
Measured: after all data has been collected, analysis will be finished within 5 days
Catheterization time
Time from indwelling catheter intraoperatively to removing catheter postoperatively
Measured: after all data has been collected, analysis will be finished within 5 days
Hospital stay
The hospital stay is the total number of days from the admission to the discharge of patients
Measured: after all data has been collected, analysis will be finished within 5 days
Complication
Obturator nerve reflex, perforation, urethral stricture, hydronephrosis
Measured: after all data has been collected, analysis will be finished within 5 days
The recurrence rate of tumor in situ
The proportion of patients with postoperative tumor recurrence in situ in all patients after a 12-month follow-up
Measured: after all data has been collected, analysis will be finished within 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 May 2018
- Primary completion30 Dec 2020
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muwen Wang, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290623
- Sponsor's protocol ID
- SWYX:NO. 2022-085
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19954353Zhu 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.
PubMed 18649930Nagele 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.
PubMed 21305303Herrmann 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.
PubMed 28033148Fried 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.
PubMed 15735378He 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.
PubMed 24735433Tao 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.
PubMed 23694918Bai 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.
PubMed 25256383Chen 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.
PubMed 27454755Kramer 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.
PubMed 25910478Lingenfelder 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.
PubMed 19343433Park 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.
PubMed 26867548Cheng 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.
PubMed 30589047Fritsche 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.
PubMed 21815824Kaehler 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.
PubMed 17299266
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-power Green-light Laser Endoscopic Submucosal Dissection for Non-muscle-invasive Bladder Cancer: a Technical Improvement and Its Initial Application
- ClinicalTrials.gov ID
- NCT05290623
- Acronym / sponsor ID
- SWYX:NO. 2022-085
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: In recent years, endoscopic laser surgery has been introduced to the treatment of NMIBC. Various types of laser (holmium laser, thulium laser and green-light laser) have been examined in the treatment of NMIBC, and the cutting power has been raised gradually. In our previous study, a 120 W green-light laser was used to perform en bloc resection, which yielded encouraging results. Endoscopic submucosal dissection by the HybridKnife was reported to be safe and effective in the treatment of NMIBC. However, previous resection was performed by electrical instrument. To further enhance the safety and accuracy of the operation, surgeons improved the treatment by combining laser resection and endoscopic submucosal dissection (ESD). This novel surgical treatment can also integrate advantages of each method. A retrospective study was designed in this study. The aim of the study was to evaluate the safety and efficacy of this novel surgical treatment, high-power green-light laser endoscopic submucosal dissection (HPL-ESD), in the treatment of primary non-muscle-invasive bladder cancer (NMIBC).
Introduction: Greenlight lasers are developed from Nd:YAG laser. Visual laser vaporization with Nd:YAG laser was introduced for the treatment of bladder cancer in the early 1990s. However, the low-absorption in most tissues with a penetration depth of 4-18mm leading to a deep coagulative necrosis of tissue, which increased the risk of delayed bladder perforation and bowel injury. Passing the Nd:YAG-produced beam (1046nm) through a KTP or LBO crystal, leads to a green visible light beam of 532nm, which has a completely different laser beam-tissue interaction. The wavelength is not absorbed by water but strongly absorbed by hemoglobin, which limits the optical penetration depth of green light laser to 0.8 mm, and the heat remaining in the tissue induces a coagulation zone of only 1-2mm thickness. Recent studies show that greenlight laser vaporization is a reliable and feasible treatment for the patients with primary NMIBC compared with standard TURBT.
On the basis of our previous surgical procedure, we developed this new surgical method by introducing ESD technology. Thus LBO laser en bloc resection was combined with the ESD technique to treat NMIBC, which was inspired by waterjet-assisted ESD in the department of gastroenterology. ESD was developed from endoscopic mucosal resection (EMR) and widely applied for the treatment of early gastroesophageal cancer and colorectal neoplasms. The bladder wall shares a similar histological structure with the gastrointestinal tract, although the muscularis propria is thicker. Therefore, forming a submucosal fluid cushion in the bladder wall should be feasible and even safer. The effects of submucosal fluid cushion on bladder wall were showed intuitively. The interspace between the mucosal layer and the detrusor muscle layer was increased, and the tissue between the two layers was rendered looser. In the present study, the submucosal fluid cushion increases safety during the operation. More importantly, when the normal mucosa was incised, the detrusor muscle layer beneath was exposed, which facilitated distinction of which layer was reached and incision of the entire tumor with the superficial detrusor muscle beneath the basal part. To some extent, introduction of the ESD technique enabled safe, controllable and accurate incision.
Equipment: The equipment included a 23F continuous flow resectoscope through which a 6F green-light lithium triborate (LBO) laser fiber (Realton, Beijing, China) could be delivered via the working channel. In addition, a disposable injector was used to form the submucosal fluid cushion for ESD. The stainless steel needle of the injector is 5 mm in length and 0.6 mm in diameter (terminal part). The working length and diameter are 1650 mm and 2.5 mm respectively (middle part), enabling delivery through the working channel of the resectoscope. The beginning part of the injector was connected to a 20-ml syringe containing methylene blue solution as the injection fluid.
HPL-ESD procedure: All surgeries were conducted in the lithotomy position under continuous epidural anesthesia. Sodium chloride physiological solution was used for irrigation. The 23F continuous flow resectoscope was delivered into the bladder through the urethra initially. Each visible tumor was examined to confirm the location, number, and size and the condition of the adjacent mucosa. Then, the 6F green-light LBO laser fiber was delivered through the working channel of the resectoscope. Each tumor was first marked with a circular coagulation blockage border, which was 1-2 cm from the edge of the tumor. Next, the laser fiber was temporarily withdrawn and the disposable injector was delivered through the same working channel of the resectoscope. Multipoint injection was performed in the normal mucosa along the blockage border. Because the tissue between the mucosal layer and the detrusor muscle layer in the bladder wall is relatively loose, a blue submucosal fluid cushion was formed between the two layers after injection. Subsequently, the green-light laser was delivered through the working channel again. The laser power was set at 160 W for cutting and 30-50 W for coagulation simultaneously. The mucosa was incised annularly, and the detrusor muscle layer beneath it was gradually exposed. The submucosal fluid cushion separated the mucosa layer and the detrusor muscle layer to some extent in advance. Therefore, the course and distribution of the detrusor muscle could be clearly observed. Dissection of tissue connected between the tumor and the bladder wall was also facilitated. The entire tumor was excised with superficial detrusor muscle beneath the basal part. After resection, the whole tumor bed and surrounding mucosa were carefully coagulated at a power of 30-50 W. The intact bladder tumor was removed with an alligator forceps or flushed out with an Ellik evacuator. When the tumor size was > 3 cm, the specimen was longitudinally cut into two or more parts.
Clinical data will be collected, such as patient data, tumor characteristics, and perioperative data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with non-muscle invasive bladder cancer who received high-power green laser submucosal resection of bladder tumor
Key exclusion criteria (3 listed)
- Patients with muscle invasive bladder cancer
- Patients with recurrent bladder cancer
- Patients with benign bladder tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Success rate of the surgery
Time frame: after all data has been collected, analysis will be finished within 5 days
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.
7 secondary outcomes
Rate of tumor en bloc resection
Time frame: after all data has been collected, analysis will be finished within 5 days
Operative time
Time frame: after all data has been collected, analysis will be finished within 5 days
Hemoglobin decrease
Time frame: after all data has been collected, analysis will be finished within 5 days
Catheterization time
Time frame: after all data has been collected, analysis will be finished within 5 days
Hospital stay
Time frame: after all data has been collected, analysis will be finished within 5 days
Complication
Time frame: after all data has been collected, analysis will be finished within 5 days
The recurrence rate of tumor in situ
Time frame: after all data has been collected, analysis will be finished within 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Background: PubMed 19954353Xishuang 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.
- Background: PubMed 18649930Zhu 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.
- Background: PubMed 21305303Nagele 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.
- Background: PubMed 28033148Herrmann 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.
- Background: PubMed 15735378Fried 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.
- Background: PubMed 24735433He 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.
- Background: PubMed 23694918Tao 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.
- Background: PubMed 25256383Bai 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.
- Background: PubMed 27454755Chen 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.
- Background: PubMed 25910478Kramer 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.
- Background: PubMed 19343433Lingenfelder 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.
- Background: PubMed 26867548Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Shandong Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of the surgery (time frame: after all data has been collected, analysis will be finished within 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05290623, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.