Stop or Ongoing Oral Anticoagulation in Patients Undergoing Pvp (SOAP)

Sponsor

Dr Vincent Misrai (Other)

Overall Status

Recruiting

CT.gov ID

NCT03297281

Collaborator

Boston Scientific Corporation (Industry), Capionis (Other)

389

Enrollment

Location

Arms

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Oct 30, 2017

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

May 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 [Between day 0 (day of the surgery) and day 30 (1 month after surgery)]

Secondary Outcome Measures

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 [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 [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 [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 [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 [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 [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 [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 [At 1 month, 3 months and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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