ABSTRACT
STUDY QUESTION: Is increasing the intensity of high-intensity focused ultrasound (HIFU) by 30% in the treatment of rectal endometriosis a safe procedure? SUMMARY ANSWER: This study demonstrates the safety of a 30% increase in the intensity of HIFU in the treatment of rectal endometriosis, with no Clavien-Dindo Grade III complications overall, and namely no rectovaginal fistulae. WHAT IS KNOWN ALREADY: A feasibility study including 20 patients with rectal endometriosis demonstrated, with no severe complications, a significant improvement in digestive disorders, dysmenorrhoea, dyspareunia, and health status, although the volume of the endometriosis nodule did not appear to be reduced. STUDY DESIGN, SIZE, DURATION: A prospective multicentre cohort study was conducted between 2020 and 2022 with 60 patients with symptomatic rectal endometriosis. Following the failure of medical treatment, HIFU treatment was offered as an alternative to surgery. PARTICIPANTS/MATERIALS, SETTING, METHODS: As the main objective of this study was to examine safety, all adverse events observed during the 6 months of follow-up were analysed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) and Clavien-Dindo classifications. Secondary objectives included evaluating the evolution of symptoms using validated questionnaires: gynaecological and digestive pain symptoms with a visual analogue scale, health status with the Medical Outcomes Study 36-item Short Form (SF-36) questionnaire, average post-operative daily pain level, and analgesic medication required in the 10 days following treatment. MRI was also performed at Day 1 to detect early complications. Finally, we performed a blinded MRI review of the evolution of the nodule at 6 months post-treatment. MAIN RESULTS AND THE ROLE OF CHANCE: The procedure was performed under spinal anaesthesia for 30% of the patients. The median duration of treatment was 32 min. Fifty-five patients left the hospital on Day 1. MRI scans performed on Day 1 did not highlight any early-onset post-operative complication. Using the Clavien-Dindo classification, we listed 56.7% Grade I events, 3.4% Grade II events, and no events Grade III or higher. At 1, 3, and 6 months, all gynaecologic, digestive and general symptoms, as well as health status, had significantly improved. The evolution of the nodule was also significant (P < 0.001) with a 28% decrease in volume. LIMITATIONS, REASONS FOR CAUTION: The main objective was safety and not effectiveness. The study was not randomized and there was no control group. WIDER IMPLICATIONS OF THE FINDINGS: HIFU treatment for rectal endometriosis results in an improvement of symptoms with low morbidity; as such, for selected patients, it could be a valuable alternative to surgical approaches following the failure of medical treatment. STUDY FUNDING/COMPETING INTEREST(S): The study was funded by the company EDAP TMS. Professors Dubernard and Rousset are consultants for EDAP TMS. Dubernard received travel support from EDAP-TMS. Dr F. Chavrier received industrial grants from EDAP-TMS. He has developed a device for generating focused ultrasonic waves with reduced treatment time. This device has been patented by EDAP-TMS. Dr Lafon received industrial grants from EDAP-TMS; he declares that EDAP-TMS provided funding directly to INSERM to support a young researcher chair in therapeutic ultrasound, which is unrelated to the current study. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT04494568.
Subject(s)
Endometriosis , Rectal Diseases , Humans , Female , Endometriosis/therapy , Endometriosis/surgery , Endometriosis/diagnostic imaging , Adult , Prospective Studies , Rectal Diseases/therapy , France , Treatment Outcome , High-Intensity Focused Ultrasound Ablation/methods , High-Intensity Focused Ultrasound Ablation/adverse effects , Middle Aged , Dysmenorrhea/therapy , Dyspareunia/etiology , Dyspareunia/therapyABSTRACT
Tumors of trophoblast implantation site TTSI are rare gestational tumors. This case highlights the diagnostic difficulties and treatment of tumors of trophoblastic implantation site early. Patient of 28 years with no medical history, G1P1 who gave birth 11 months ago presented bleeding with an HCG level of 73IU that led to the diagnosis of early miscarriage. Treatment of miscarriage by hysteroscopy and curettage is complicated leading to the realization of an abdominopelvic CT and pelvic ultrasound that show an atypical uterine vascularity and an intracavitary heterogeneous mass. The pelvic MRI performed evokes a TTSI stage I. A hysterectomy with bilateral salpingectomy and ovarian conservation is achieved. Despite the standard treatment with surgery the HCG levels do not normalize before seven months after surgery. This indicates an adjuvant chemotherapy, the patient refuses. The presented case illustrates the diagnostic difficulties of the disease. He noted the importance of the second reading network proposed by the specialized center in Lyon. It also raises the question of adjuvant chemotherapy in some cases of early stage TTSI. The challenge is to define cases requiring adjuvant therapy. Predictors of chemotherapy in early stages could be tumor size, degree of infiltration of the myometrium and mutation p53. Amenorrhea, bleeding associated with uterine atypical vascularization, and atypical development of HCG<1000IU and/or unusual complications of treatment of miscarriage should evoke a tumor site trophoblastic implantation. Hysterectomy is the first treatment in early stages. Tumor size, degree of infiltration of the myometrium and mutation p53 are predictors to assess in multicentre studies to define the indications of postoperative chemotherapy.