Ignite Creation Date:
2024-05-06 @ 10:37 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03305861
Status:
RECRUITING
Last Update Posted:
2023-11-01
First Post:
2017-09-22
Brief Title:
Green LEP vs ThuLEP in Management of Marked Enlarged Prostate
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
GreenLight 532nm LASER XPS Enucleation vs Thulium LASER Enucleation of Prostate for Treatment of Benign Prostatic Hyperplasia
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the investigators aim to test TGreenlight 532-nm laser Photoselective Enucleation of the Prostate Green LEP using XPS 180W system vs Thulium Laser 200 W Enucleation of the Prostate ThuLEP in reduction of lower urinary tract symptoms LUTS secondary to benign prostatic hyperplasia BPH in a randomized controlled trial Furthermore all peri-operative parameters urinary flow parameters prostate size changes and complications associated with the procedures will be compared
Detailed Description:
Transurethral resection of the prostate TURP and open simple prostatectomy SP have been the historical reference-standard procedures for prostates 80 g and 80 to 100 g respectively for years
Evolution of LASER technology revived the concept of enucleation so that the resectoscope can be used instead of the surgeons index finger to separate the adenoma from the surgical capsule mimicking OP There are several types of laser energy available for enucleation but the commonest types are Holmium Greenlight 532nm and Thulim YAG LASERS
Thulium yttrium-aluminium-garnet laser Thulium LASER works at a wavelength between 1940 and 2013 nm in continuous wave mode so it offers advanced vaporization and hemostatic features Different applications and techniques were developed ranging from vapoenucleation technique with in situ laser assisted resection so-called Tangerine technique Thulium Laser resection of the prostate Tangerine Technique TmLRP-TT and enucleation ThuVEPThuLEP are published
Inspite of paucity of RCT comparing ThuLEP to other standard techniques in management of large prostate long term outcomes of ThuLEP are so robust Gross et al reported their 5 year follow up after ThuVEP in 500 patients with median prostate size of 50 grams They demonstrated durable outcomes with persistent reductions in I-PSS score 5 vs 21 QoL score 1 vs 4 and improvement in Q max 163 vs 69 mlsec Late complications included urethral stricture in 31 BNC in 31 and recurrent adenoma in 06
Yang et al published their 5 year results of a RCT comparing ThuLEP vs TURis in 159 patients with median prostate size of 70 gm No statistically significant difference between both groups in terms of IPSS Qmax or post voiding residual No patient in either group required retreatment
In RCT by Feng et al comparing ThuLEP to PKEP with 18 months follow up results the former proved to be efficient and safe within 12 months follow-up interval However ThuLEP had significantly better hemostasis parameters and shorter catheterization time
III GreenLight 532nm laser system
The Kalium-Titanyl-Phosphate KTP and the lithium triborate LBO lasers work at a wavelength of 532 nm Laser energy is absorbed by haemoglobin but not by water Vaporisation leads to immediate removal of prostatic tissue relief of BPO and reduction of LUTS GreenLight laser has gained increasing acceptance as a less invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia BPH LUTS
A meta-analysis of the nine available RCTs comparing PVP using the 80-W and 120-W lasers with TURP no differences were found in Qmax and IPSS between 80-W-PVP and TURP but only two RCTs provided sufficient 12-month data to be included in the meta-analysis
With the 180-W XPS laser efficacy is comparable to TURP in terms of IPSS Qmax post voided residual volume prostate volume reduction PSA decrease and QoL questionnaires The XPS laser prostatectomy is superior to TURP in terms of catheterisation time lengths of hospital stay and time to stable health status
In a RCT by Al-Ansari et al comparing HPS 120-W laser PVP versus TURP the former was associated with dramatic improvements in all urinary outcomes compared to TURP but reintervention rate for recurrent adenomas was 11 compared to 18 in TURP group All patients who needed redo surgery had prostate larger than 80 gm
In another RCT El-Shal et al of a compared Greenlight laser 180W XPS vapo enucleation where the adenoma is bluntly enucleated partially then vaporized in situ and HoLEP and reported 12 months follow up results Green light XPS vapoenucleation was comparable and non inferior to HoLEP in symptom improvement However at 12 months Q max prostate size reduction and PSA reduction were significantly higher in HoLEP group
These important findings highlighted some limitations in PVP or vapoenucleation such as the difficulty in determining the anatomical cleavage limits and capsular plain of large adenomas These drawbacks are not related to the energy source but to the technique used
Gomez Sancha described different technique to avoid these limitations which was Greenlight LASER En-bloc Enucleation of Prostate Green LEP where the whole adenoma is dissected from the surgical capsule and morcellated at the end
Misrai et al compared Green LEP vs Greenlight PVP for management of prostates larger than 80 gms At 6 months follow up IPSS QoL and PVR improved similarly in both groups but Q max was significantly higher in Green LEP group Median percent reduction in prostate size as measured by TRUS was significantly higher in green LEP 74 vs 57 Median reduction of PSA was 40 and 67 in PVP and Green LEP respectively p00001
There is a paucity in studies comparing different types of EEP using different energy sources other than holmium laser
Aim of the work In this study the investigators aim to test Thulium Laser 200 W Enucleation of the Prostate ThuLEP vs Greenlight 532-nm laser Photoselective Enucleation of the Prostate Green LEP using XPS 180W system in reduction of LUTS secondary to BPH in a randomized controlled trial Furthermore all peri-operative parameters urinary flow parameters prostate size changes and complications associated with the procedures will be compared
Evolution of LASER technology revived the concept of enucleation so that the resectoscope can be used instead of the surgeons index finger to separate the adenoma from the surgical capsule mimicking OP There are several types of laser energy available for enucleation but the commonest types are Holmium Greenlight 532nm and Thulim YAG LASERS
Thulium yttrium-aluminium-garnet laser Thulium LASER works at a wavelength between 1940 and 2013 nm in continuous wave mode so it offers advanced vaporization and hemostatic features Different applications and techniques were developed ranging from vapoenucleation technique with in situ laser assisted resection so-called Tangerine technique Thulium Laser resection of the prostate Tangerine Technique TmLRP-TT and enucleation ThuVEPThuLEP are published
Inspite of paucity of RCT comparing ThuLEP to other standard techniques in management of large prostate long term outcomes of ThuLEP are so robust Gross et al reported their 5 year follow up after ThuVEP in 500 patients with median prostate size of 50 grams They demonstrated durable outcomes with persistent reductions in I-PSS score 5 vs 21 QoL score 1 vs 4 and improvement in Q max 163 vs 69 mlsec Late complications included urethral stricture in 31 BNC in 31 and recurrent adenoma in 06
Yang et al published their 5 year results of a RCT comparing ThuLEP vs TURis in 159 patients with median prostate size of 70 gm No statistically significant difference between both groups in terms of IPSS Qmax or post voiding residual No patient in either group required retreatment
In RCT by Feng et al comparing ThuLEP to PKEP with 18 months follow up results the former proved to be efficient and safe within 12 months follow-up interval However ThuLEP had significantly better hemostasis parameters and shorter catheterization time
III GreenLight 532nm laser system
The Kalium-Titanyl-Phosphate KTP and the lithium triborate LBO lasers work at a wavelength of 532 nm Laser energy is absorbed by haemoglobin but not by water Vaporisation leads to immediate removal of prostatic tissue relief of BPO and reduction of LUTS GreenLight laser has gained increasing acceptance as a less invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia BPH LUTS
A meta-analysis of the nine available RCTs comparing PVP using the 80-W and 120-W lasers with TURP no differences were found in Qmax and IPSS between 80-W-PVP and TURP but only two RCTs provided sufficient 12-month data to be included in the meta-analysis
With the 180-W XPS laser efficacy is comparable to TURP in terms of IPSS Qmax post voided residual volume prostate volume reduction PSA decrease and QoL questionnaires The XPS laser prostatectomy is superior to TURP in terms of catheterisation time lengths of hospital stay and time to stable health status
In a RCT by Al-Ansari et al comparing HPS 120-W laser PVP versus TURP the former was associated with dramatic improvements in all urinary outcomes compared to TURP but reintervention rate for recurrent adenomas was 11 compared to 18 in TURP group All patients who needed redo surgery had prostate larger than 80 gm
In another RCT El-Shal et al of a compared Greenlight laser 180W XPS vapo enucleation where the adenoma is bluntly enucleated partially then vaporized in situ and HoLEP and reported 12 months follow up results Green light XPS vapoenucleation was comparable and non inferior to HoLEP in symptom improvement However at 12 months Q max prostate size reduction and PSA reduction were significantly higher in HoLEP group
These important findings highlighted some limitations in PVP or vapoenucleation such as the difficulty in determining the anatomical cleavage limits and capsular plain of large adenomas These drawbacks are not related to the energy source but to the technique used
Gomez Sancha described different technique to avoid these limitations which was Greenlight LASER En-bloc Enucleation of Prostate Green LEP where the whole adenoma is dissected from the surgical capsule and morcellated at the end
Misrai et al compared Green LEP vs Greenlight PVP for management of prostates larger than 80 gms At 6 months follow up IPSS QoL and PVR improved similarly in both groups but Q max was significantly higher in Green LEP group Median percent reduction in prostate size as measured by TRUS was significantly higher in green LEP 74 vs 57 Median reduction of PSA was 40 and 67 in PVP and Green LEP respectively p00001
There is a paucity in studies comparing different types of EEP using different energy sources other than holmium laser
Aim of the work In this study the investigators aim to test Thulium Laser 200 W Enucleation of the Prostate ThuLEP vs Greenlight 532-nm laser Photoselective Enucleation of the Prostate Green LEP using XPS 180W system in reduction of LUTS secondary to BPH in a randomized controlled trial Furthermore all peri-operative parameters urinary flow parameters prostate size changes and complications associated with the procedures will be compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None