Green LEP vs ThuLEP in Management of Marked Enlarged Prostate

October 28, 2024 updated by: Mahmoud Laymon, Mansoura University

GreenLight (532nm) LASER (XPS) Enucleation vs. Thulium LASER Enucleation of Prostate for Treatment of Benign Prostatic Hyperplasia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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Transurethral resection of the prostate (TURP) and open simple prostatectomy (SP) have been the historical reference-standard procedures for prostates 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 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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Dakahlia
      • Mansoura, Dakahlia, Egypt
        • Recruiting
        • Urology and nephrology center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients' age ≥ 40 years
  • LUTS secondary to BOO due to BPH who failed medical treatment
  • International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
  • Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
  • ASA (American society of anaesthesiologists) score ≤3.
  • TRUS prostate size > /= 80 ml

Exclusion Criteria:

  • Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
  • Active urinary tract infection,
  • Presence of active bladder cancer (within the last 2 years)
  • Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
  • Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
  • Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg).
  • Patient has had an acute myocardial infarction or open-heart surgery <180 days prior to the date of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ThuLEP
Thulium laser enucleation of prostate
Thulium laser enucleation of prostate
Experimental: Green LEP
Greenlight laser enucleation of prostate
Greenlight laser enucleation of prostate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
voiding and storage symptoms improvement
Time Frame: 6 months
International Prostate Symptom Score (I-PSS)
6 months
sexual function changes
Time Frame: 6 months
International Index of Erectile Function Questionnaire (IIEF)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: 6 months
in minutes
6 months
Postoperative complication
Time Frame: 12 months
Clavien-Dindo classification for post-operative complications
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

October 4, 2017

First Posted (Actual)

October 10, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MD/17.02.26

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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