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Trial record 1 of 1 for:    soap | prostate | France
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Stop or Ongoing Oral Anticoagulation in Patients Undergoing Pvp (SOAP) (SOAP)

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ClinicalTrials.gov Identifier: NCT03297281
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Boston Scientific Corporation
Capionis
Information provided by (Responsible Party):
Dr Vincent Misrai, Clinique Pasteur

Tracking Information
First Submitted Date  ICMJE September 12, 2017
First Posted Date  ICMJE September 29, 2017
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE October 30, 2017
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
Number of patients with at least one complication classified higher or equal to grade 2 according to the Clavien classification related to maintenance of oral-anticoagulant (OAC) during the surgical resection of BPH by laser at 1 month [ Time Frame: Between day 0 (day of the surgery) and day 30 (1 month after surgery) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
  • Number of patients with at least one hemorrhagic complication related to maintenance of oral-anticoagulant (OAC) during the surgical resection of BPH by laser at 1 month, 3 months and 6 months [ Time Frame: At 1 month, 3 months and 6 months ]
    Haemorrhagic complications are defined by hematuria, bladder clotting removed from patient bed or operating room.
  • Number of patients with at least one thrombotic complication related to maintenance of oral-anticoagulant (OAC) during the surgical resection of BPH by laser at 1 month, 3 months and 6 months [ Time Frame: At 1 month, 3 months and 6 months ]
    Thrombotic complications are defined by stroke, transient ischemic attacks and systemic embolisms.
  • Duration of hospitalization related to perioperative management of anticoagulants will be measured at the patient's discharge [ Time Frame: At the patient's discharge, on average 3 days after surgery ]
  • Prostatic residual volume will be measured to evaluate the quality of resection under oral-anticoagulant at 1 month, 3 months, and 6 months [ Time Frame: At 1 month, 3 months and 6 months ]
  • PSA level will be measured to evaluate the quality of resection under oral-anticoagulant at 1 month, 3 months, and 6 months [ Time Frame: At 1 month, 3 months and 6 months ]
  • Questionnaires International Prostate Symptom Score (IPSS) will be complemented by patients to evaluate the functional success of surgery under oral-anticoagulant at 1 month, 3 months and 6 months [ Time Frame: At 1 month, 3 months and 6 months ]
  • International Continence Society (ICS) will be complemented by patients to evaluate the functional success of surgery under oral-anticoagulant at 1 month, 3 months and 6 months [ Time Frame: At 1 month, 3 months and 6 months ]
  • Volume of post-voiding residue will be measured to evaluate the functional success of surgery under oral-anticoagulant at 1 month, 3 months and 6 months [ Time Frame: At 1 month, 3 months and 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stop or Ongoing Oral Anticoagulation in Patients Undergoing Pvp (SOAP)
Official Title  ICMJE Multicenter Randomized Open-labelled Trial Which Aims to Show Non-inferiority of Adverse Events Risk During the Maintenance of Oral-anticoagulation in the Surgery of Benign Prostatic Hypertrophy by Laser Photovaporization
Brief Summary

Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half of the patients recruited had an aggravation of their disease over time either by an increase in symptoms or by the appearance of complications such as acute retention of urine.

For benign symptomatic prostate hypertrophy, apart from any complication, first-line treatment is now a medical treatment. For patients who respond poorly to medical treatment or who have complications related to benign prostatic hypertrophy, the treatment becomes surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to improve the safety of hemostasis in patients older and older and at significant surgical risk that new "minimally invasive" surgical techniques have emerged. Thus, lasers have been developed and are currently used as an alternative to the TURP. Used in clinical practice since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate tissue.

Given the aging of the population, more and more patients are being treated with oral anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The peri-operative management of the AVK is currently based on the recommendations published by the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs, the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015.

Numerous studies published in the literature have concluded the feasibility of prostate removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs because of the properties of hemostasis. But the levels of evidence for these studies remain low.

No study has focused on rigorously assessing the perioperative hemorrhagic risk associated with OAC therapy in patients eligible for PVP, and this is the originality of this study.

This study is a multicenter prospective randomized study whose objective is to show that the PVP performed in patients with OAC is not associated with an increase in perioperative hemorrhagic risk.

Detailed Description

SOAP is a non-inferiority, multicentric, open-labelled, two parallel arms study.

The expected benefits are to foster and make the perioperative management of OAC safer in patients undergoing BPH surgery with PVP.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Benign Prostatic Hyperplasia
  • Anticoagulant Adverse Reaction
Intervention  ICMJE
  • Other: Maintenance of OAC in surgery of BPH by PVP.
    The maintenance of AVK or DOACs treatment in the perioperative setting (without interruption of oral treatment).
  • Other: Discontinuation of OAC in surgery of BPH by PVP.
    The discontinuation of AVK or DOACs treatment with perioperative heparin relay during postoperative course.
Study Arms  ICMJE
  • Experimental: S1: maintenance
    Maintenance of OAC in surgery of BPH by PVP.
    Intervention: Other: Maintenance of OAC in surgery of BPH by PVP.
  • Active Comparator: S2 : discontinuation
    Discontinuation of OAC in surgery of BPH by PVP.
    Intervention: Other: Discontinuation of OAC in surgery of BPH by PVP.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 2, 2019)
389
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2017)
386
Estimated Study Completion Date  ICMJE May 1, 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Prostate volume ≤ 80 gr
  • Micturition disorders resistant to medical treatment related to HBP and/or complications related to BPH (retention, lithiasis...)
  • Patient candidate for photovaporization of the prostate
  • Patient under treatment AVK (Anti Vitamin K) for more than 3 months with an objective of INR (International Normalized Ratio) between 2 and 3 or patient under DOACs (Direct Oral Anti-coagulants) for more than 3 months
  • Unprotected major
  • Patient affiliated to a social security scheme or equivalent
  • Patient is willing and able to comply with all study requirements and to sign a study-specific informed consent form.

Exclusion Criteria:

  • History of prostate cancer
  • Previous pelvic radiotherapy
  • History of stenosis of the urethra
  • Patient with one or more bladder polyps
  • Patient under antiplatelet agent other than aspirin
  • Allergy to heparin or history of heparin-induced thrombocytopenia
  • Patients under anticoagulant injectable therapy at baseline (heparin, LMWH (Low Molecular Weight Heparin), fondaparinux)
  • Any mechanical prosthetic heart valve
  • Stroke (ischemic or hemorrhagic), systemic embolism or transient ischemic attack within past 12 weeks
  • Venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12 weeks
  • Major bleeding within past 6 weeks
  • Severe renal insufficiency (calculated creatinine clearance < 30 mL / min)
  • Thrombocytopenia (platelet count < 100 x 10^9 / L)
  • Life expectancy < 1 month
  • Condition that impairs compliance with trial protocol (e.g. cognitive impairment, uncontrolled psychiatric condition, geographic inaccessibility)
  • Contra-indication to PVP surgery or contra-indication to general anesthesia
  • Protected patients : majors under some form of guardianship
  • Patient participating in another clinical study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vincent Misraï, Dr 05 62 21 33 26 vmisrai@clinique-pasteur.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03297281
Other Study ID Numbers  ICMJE 2017-A01236-47
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Vincent Misrai, Clinique Pasteur
Study Sponsor  ICMJE Dr Vincent Misrai
Collaborators  ICMJE
  • Boston Scientific Corporation
  • Capionis
Investigators  ICMJE
Principal Investigator: Vincent Misrai, Dr Clinique Pasteur
PRS Account Clinique Pasteur
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP