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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

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.


Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Anticoagulant Adverse Reaction Other: Maintenance of OAC in surgery of BPH by PVP. Other: Discontinuation of OAC in surgery of BPH by PVP. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: S1: maintenance
Maintenance of OAC in surgery of BPH by PVP.
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).

Active Comparator: S2 : discontinuation
Discontinuation of OAC in surgery of BPH by PVP.
Other: Discontinuation of OAC in surgery of BPH by PVP.
The discontinuation of AVK or DOACs treatment with perioperative heparin relay during postoperative course.




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297281


Contacts
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Contact: Vincent Misraï, Dr 05 62 21 33 26 vmisrai@clinique-pasteur.com

Locations
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France
Clinique Pasteur Recruiting
Toulouse, France, 31 076
Contact: Vincent Misraï, Dr    05 62 21 33 26    vmisrai@clinique-pasteur.com   
Principal Investigator: Aurélien Descazeaud, Pr         
Principal Investigator: Nicolas Barry Delongchamps, Dr         
Principal Investigator: Emmanuel Della Negra, Dr         
Principal Investigator: Romain Mathieu, Dr         
Principal Investigator: Gilles Karsenty, Pr         
Principal Investigator: Jean Alexandre Long, Dr         
Principal Investigator: Charles Ballereau, Dr         
Sub-Investigator: Abdel-Rahmène Azzouzi, Dr         
Principal Investigator: Franck Bruyère, Pr         
Sub-Investigator: Georges Fournier, Pr         
Sub-Investigator: Luc Corbel, Dr         
Sub-Investigator: Sébastien Vincendeau, Dr         
Sub-Investigator: Gaëlle Fiard, Dr         
Sub-Investigator: Caroline Thuillier, Dr         
Sub-Investigator: Jean-Luc Descotes, Pr         
Sub-Investigator: Cécilia Lanchon, Dr         
Sub-Investigator: Pierre Colin, Dr         
Principal Investigator: Souhil Lebdai, Dr         
Sub-Investigator: Thibaut Culty, Dr         
Principal Investigator: Jehanne Calves, Dr         
Sub-Investigator: Camille Overs, Dr         
Sub-Investigator: Pierre Bigot, Pr         
Sub-Investigator: Julie Carrouget, Dr         
Principal Investigator: Idir Ouzaid, Dr         
Sub-Investigator: Evanguelos Xylinas, Dr         
Principal Investigator: Matthieu Durand, Dr         
Sub-Investigator: Brannwel Tibi, Dr         
Sub-Investigator: Youness Ahallal, Dr         
Sponsors and Collaborators
Dr Vincent Misrai
Boston Scientific Corporation
Capionis
Investigators
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Principal Investigator: Vincent Misrai, Dr Clinique Pasteur
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Vincent Misrai, Investigator coordinator, Clinique Pasteur
ClinicalTrials.gov Identifier: NCT03297281    
Other Study ID Numbers: 2017-A01236-47
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Vincent Misrai, Clinique Pasteur:
Photovaporization
Laser
Benign prostatic hyperplasia
Oral anticoagulation
Complication
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male