Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03305861 |
| Other study ID # |
MD/17.02.26 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2017 |
| Est. completion date |
February 1, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Mansoura University |
| Contact |
Mahmoud Nabil Laymon, MD |
| Phone |
00201002275698 |
| Email |
dr_mahmoudlaymon[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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the historical reference-standard procedures for prostates 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 surgeon's 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 (ThuVEP/ThuLEP 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 (16.3 vs 6.9 ml/sec). Late complications included urethral
stricture in 3.1%, BNC in 3.1% and recurrent adenoma in 0.6%.
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 1.8% 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 (p<0.0001).
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.
