Artificial Intelligence Imaging Diagnosis Using Super-Resolution and 3D Shape for Lymph Node Metastasis of Low Rectal Cancer: A Pilot Study From a Single Center.

BACKGROUND: Although accurate preoperative diagnosis of lymph node metastasis is essential for optimizing treatment strategies for low rectal cancer, the accuracy of present diagnostic modalities has room for improvement. OBJECTIVE: To establish a high-precision diagnostic method for lymph node metastasis of low rectal cancer using artificial intelligence. DESIGN: A retrospective observational study. SETTINGS: A single cancer center and a college of engineering in Japan. PATIENTS: Patients with low rectal adenocarcinoma who underwent proctectomy, bilateral lateral pelvic lymph node dissection, and contrast-enhanced multi-detector row computed tomography (slice ≤1 mm) between July 2015 and August 2021 were included in the present study. All pelvic lymph nodes from the aortic bifurcation to the upper edge of the anal canal were extracted, regardless of whether within or beyond the total mesenteric excision area, and pathological diagnoses were annotated for training and validation. MAIN OUTCOME MEASURES: Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. RESULTS: A total of 596 pathologically negative and 43 positive nodes from 52 patients were extracted and annotated. Four diagnostic methods, with and without using super-resolution images and without using 3D shape data, were performed and compared. The super-resolution + 3D shape data method had the best diagnostic ability for the combination of sensitivity, negative predictive value, and accuracy (0.964, 0.966, and 0.968, respectively), while the super-resolution only method had the best diagnostic ability for the combination of specificity and positive predictive value (0.994 and 0.993, respectively). LIMITATIONS: Small number of patients at a single center and the lack of external validation. CONCLUSIONS: Our results enlightened the potential of artificial intelligence for the method to become another game changer in the diagnosis and treatment of low rectal cancer. See Video Abstract.

Assessment of diagnostic accuracy for cryptorchidism and risk factors for delayed orchidopexy.

OBJECTIVES: Cryptorchidism (CO) diagnosis by palpation is challenging. Patients with suspected CO are primarily referred to pediatric urologists by general pediatricians and urologists. Currently, surgical treatment for CO is recommended earlier than in previous guidelines. In this study, we evaluated factors that lead to diagnosis discordance and delayed orchidopexy in patients referred with suspected CO in addition to timing of initial screening. METHODS: In total, 731 patients (1052 testes) with suspected CO were included. Risk factors for diagnostic discrepancy in CO diagnosis by pediatric urologists and risk of delayed orchiopexy were evaluated. RESULTS: Herein, 659 (90%) patients were diagnosed during routine public health checkups for infants and young children, and 419 (57%) patients were referred by pediatric practitioners. Of 1052 testes, 374 (36%) were diagnosed with CO by pediatric urologists. In multivariate analysis, risk factors of diagnostic discrepancy for CO diagnosis by pediatric urologists were bilateral testis (odds ratio [OR] = 9.17, p < 0.0001), >6 months old at initial diagnosis (OR = 1.036, p < 0.0001), and pediatric referral (OR = 4.60, p < 0.0001). In total, 296 patients underwent orchiopexy for CO. In multivariate analysis, risk factors for delayed orchiopexy were presence of comorbidities (OR = 3.43, p = 0.003) and >10 months old at referral (OR = 12.62, p < 0.0001). CONCLUSIONS: Pediatric referral is a risk factor for discordant CO diagnostics, and late age at referral brings a risk of delayed orchiopexy. It is necessary to enlighten pediatricians, who are mainly responsible for routine health checkups, in teaching CO diagnostic techniques to ensure early referral.

Long-term follow-up of congenital hydronephrosis in a single-center study.

OBJECTIVES: Many congenital hydronephroses spontaneously resolve. This study evaluated a long-term follow-up of more than 4 years of patients with congenital hydronephrosis at a single center. METHODS: In total, 215 patients (286 kidneys) with congenital hydronephrosis were included. Hydronephrosis outcomes (resolution, improvement, and persistence) and time-to-outcome were evaluated. RESULTS: Fourteen patients underwent early surgical intervention until the age of 2 years. A total of 189 congenital hydronephrosis cases (66%) showed resolution at a median of 16 months (interquartile range: 7-21 months) and 169 (80%) of 210 kidneys with grade I to II hydronephrosis showed resolution at a median of 14 months (interquartile range: 6-23 months). Of 76 kidneys with grade III to IV hydronephrosis, 24 (32%) showed resolution at a median of 29 months (interquartile range: 24-41 months), and 56 (74%) showed improvement to grade II or less at a median of 12 months (interquartile range: 5-23 months). Of the 76 kidneys with grade III to IV hydronephrosis, five required delayed pyeloplasty at a median of 66 months (interquartile range: 42-89 months). One patient was asymptomatic, with a marked worsening of hydronephrosis and decreased renal function 6 years after the resolution of hydronephrosis. CONCLUSIONS: None of the patients with grade I to II hydronephrosis required surgical treatment, and a shorter follow-up may be sufficient. Grade III to IV severe hydronephrosis should be considered for a longer and more careful follow-up, given the possibility of asymptomatic exacerbation of hydronephrosis.

Impact of carcinoma in situ on the outcome of intravesical Bacillus Calmette-Guérin therapy for non-muscle-invasive bladder cancer: a comparative analysis of large real-world data.

BACKGROUND: This study investigated the clinical impact of carcinoma in situ (CIS) in intravesical Bacillus Calmette-Guérin (BCG) therapy for patients with non-muscle-invasive bladder cancer (NMIBC). METHODS: This study retrospectively evaluated 3035 patients who were diagnosed with NMIBC and treated by intravesical BCG therapy between 2000 and 2019 at 31 institutions. Patients were divided into six groups according to the presence of CIS as follows: low-grade Ta without concomitant CIS, high-grade Ta without concomitant CIS, high-grade Ta with concomitant CIS, high-grade T1 without concomitant CIS, high-grade T1 with concomitant CIS, and pure CIS (without any papillary lesion). The endpoints were recurrence- and progression-free survival after the initiation of BCG therapy. We analyzed to identify factors associated with recurrence and progression. RESULTS: At a median follow-up of 44.4 months, recurrence and progression were observed in 955 (31.5%) and 316 (10.4%) patients, respectively. Comparison of six groups using univariate and multivariate analysis showed no significant association of CIS. However, CIS in the prostatic urethra was an independent factors associated with progression. CONCLUSION: Concomitant CIS did not show a significant impact in the analysis of Ta and T1 tumors which were treated using intravesical BCG. Concomitant CIS in the prostatic urethra was associated with high risk of progression. Alternative treatment approaches such as radical cystectomy should be considered for patients with NMIBC who have a risk of progression.

Usefulness of clinical factors for diagnosing and differentiating types of testicular malposition in boys: A retrospective study.

OBJECTIVE: To investigate useful objective variables and factors supporting the diagnosis of retractile testis and cryptorchidism by primary care providers, including urologists. METHODS: This retrospective study included 512 boys diagnosed with retractile testis or cryptorchidism at our institute. Boys with retractile testis were followed up and underwent orchiopexy once the testis became undescended, while boys with cryptorchidism underwent orchiopexy immediately. We investigated trends in the prevalence of testicular malposition and explored useful diagnostic factors for retractile testis and cryptorchidism. RESULTS: Of 512 boys, 199 were diagnosed with retractile testis and 313 were diagnosed with cryptorchidism. Comparison of clinical information between retractile testis and cryptorchidism showed that age at diagnosis, laterality, and location of the testis were significantly different between the groups (P < 0.0001, P < 0.0001, and P < 0.0001, respectively). The comparison of surgical information also showed that epididymal abnormality and state of processus vaginalis is patency or closure were significantly different between the groups (P = 0.0088 and P = 0.0003, respectively). Multivariate analysis showed that diagnosis at age 0-1 years, unilaterality, and canalicular testis were predictive factors for cryptorchidism (P = 0.001, P < 0.0001, and P < 0.0001, respectively). CONCLUSIONS: Age at diagnosis, laterality, and location of the testis could be factors to aid the diagnosis of retractile testis and cryptorchidism.

Trends in treatment outcomes for retractile testis in Japanese boys: A single-center study.

OBJECTIVES: To investigate the natural course of retractile testis by analyzing its prevalence and outcomes. METHODS: This retrospective study included 215 boys in whom retractile testis was diagnosed after reviewing the medical history and physical examinations of the patients. Orchiopexy was performed once the testis became undescended. We investigated the trends in the prevalence and outcomes of retractile testis and compared clinical factors between cases that resolved spontaneously and those that required orchiopexy. RESULTS: Of 215 boys, 145 were finally evaluated. The mean age at diagnosis was 2 years, and 100 boys were aged ≤2 years when they were hospitalized. Seventy-three boys were referred to our institution through health examinations as babies. The condition improved spontaneously in 89 boys, while 43 boys underwent orchiopexy, and 13 boys remained under follow-up. The follow-up period between diagnosis and resolution was significantly longer in the spontaneous resolution group than in the surgical intervention group (P = 0.011). Bilateral retractile testis improved spontaneously in significantly more boys compared to unilateral retractile testis (P = 0.0010). Spontaneous resolution was observed in boys of all ages, but those diagnosed at ≤3 years of age had a significantly higher rate of spontaneous resolution compared to those who were diagnosed at >3 years of age (P = 0.0019). CONCLUSIONS: Our findings suggest that retractile testis cannot be affirmed as a variant of normal testis. Performing examinations at a young age is critical for preventing misdiagnosis, screening failures, and unnecessary surgery.

Periprostatic fat thickness quantified by preoperative magnetic resonance imaging is an independent risk factor for upstaging from cT1/2 to pT3 in robot-assisted radical prostatectomy.

OBJECTIVES: To analyze the correlation between periprostatic fat thickness on multiparametric magnetic resonance imaging and upstaging from cT1/2 to pT3 in robot-assisted radical prostatectomy. METHODS: We retrospectively evaluated data from men with cT1/2 prostate cancer treated with robot-assisted radical prostatectomy at Nara Prefecture General Medical Center, Nara, Japan, between March 2013 and December 2017. We calculated the periprostatic fat thickness and subcutaneous thickness from preoperative multiparametric magnetic resonance imaging. We divided the cohort into two groups for analysis. Group 1 included patients upstaged from clinical to pathological stage, whereas group 2 included those without upstaging. RESULTS: Data on 220 patients meeting the inclusion criteria were included in the analysis. A total of 36 patients were upstaged from clinical T1 or T2 to pathological T3, whereas 184 patients were not upstaged. The upstaging was associated with prostate volume, Gleason score, prostate-specific antigen density, periprostatic fat thickness, Prostate Imaging Reporting and Data System score based on univariate analysis. Multivariate analysis showed prostate volume (P = 0.03, odds ratio 0.958, 95% confidence interval 0.921-0.996), Gleason score (P = 0.022, odds ratio 2.676, 95% confidence interval 1.153-6.213) and periprostatic fat thickness (P = 0.004, odds ratio 1.26, 95% confidence interval 1.079-1.471) as independent risk factors of upstaging. CONCLUSIONS: Prostate volume, Gleason score and periprostatic fat thickness on multiparametric magnetic resonance imaging are significantly associated with and independent risk factors for upstaging from cT1/2 to pT3 in patients undergoing robot-assisted radical prostatectomy.

Trends in treatment outcomes of hydrocele in Japanese children: A single-institute experience.

OBJECTIVES: To investigate trends in treatment outcomes of surgical intervention versus observation for pediatric hydrocele. METHODS: This retrospective study included 175 patients diagnosed with hydrocele at our institution. Hydrocele was diagnosed based on medical history, physical examination and ultrasonography findings. The treatment for these patients was divided into two options: surgical intervention or careful follow up; the outcomes were investigated. RESULTS: The median age at diagnosis was 3 months, and a total of 11 patients (6%) were premature at birth. Hydrocele was diagnosed on the right side, the left side and bilaterally in 106 (61%), 46 (26%) and 23 (13%) patients, respectively. A total of 136 patients showed spontaneous improvement at the median 7 months after diagnosis, and 54 patients underwent surgical intervention. The rate of spontaneous resolution deceased with age, but spontaneous resolution was observed in patients aged >2 years. CONCLUSIONS: Our findings suggest that spontaneous resolution can be observed in patients aged >2 years, and surgical intervention can be carried out effectively and safely. Infant hydrocele should be followed up carefully for at least 1 year without surgical intervention since diagnosis. Investigation of the optimal timing of and appropriate reason for surgical intervention can lead to better management and outcomes in patients with hydrocele. Further research is warranted to support the current clinical practice.

Live electrooptic imaging with a low-coherence optical LO signal source for suppression of interference noises.

Reported in this paper is the first application, to our knowledge, of a low-coherence optical local oscillator signal source to the live electrooptic imaging (LEI) scheme, where high frequency electric field (EF) distributions are visualized in real time. A fiber-optic super luminescent diode (SLD) in conjunction with a LiNbO3 Mach-Zehnder modulator (MZM) was found to work well for the real-time imaging of gigahertz-range EF distributions with high suppression of interference pattern image noises (IPINs), which have long been a problem to be solved. While the SLD-based LEI system works up to the MZM bandwidth (10 GHz), IPINs caused by microscopic defects in an electrooptic sensor appear, suggesting a limitation given by the SLD coherence length.

Urinary nerve growth factor can predict therapeutic efficacy in children with monosymptomatic nocturnal enuresis.

AIM: To determine the urinary levels of nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) in children with monosymptomatic nocturnal enuresis (MNE) and evaluate whether these factors can be used as biomarkers for the treatment outcome. METHODS: NGF and BDNF levels were measured and compared in 38 children (28 boys and 10 girls) with MNE and 25 children (18 boys and 7 girls) with no urinary symptoms were assessed. The mean ages in the patient and control groups were 9 and 10 years, respectively (P = .49). The patients were treated with either alarm or desmopressin therapy. RESULTS: The urinary NGF/creatinine and BDNF/creatinine ratios were significantly higher in the patient group than in the control group (P = .0003 and P = .0095, respectively). NGF and BDNF levels showed a significant positive correlation (P = .0020, r = 0.40). With respect to the degree of response, 19 patients (50%) showed complete response (CR) or partial response (PR), and 19 patients (50%) showed nonresponse (NR). The urinary NGF/creatinine and BDNF/creatinine ratios were significantly higher in the NR group than in the CR and PR groups (P = .0003 and P = .0003, respectively). CONCLUSIONS: Urinary NGF/creatinine and BDNF/creatinine ratios were significantly higher in children with MNE than in healthy controls. Urinary NGF/creatinine can be predictive factors of a poor treatment outcome in children with MNE.

The diagnostic utility of retroperitoneoscopic tissue biopsy for unresectable retroperitoneal lesions excluding urogenital cancers.

BACKGROUND: Retroperitoneal tumors are an uncommon disease known to consist of a diverse group of benign and malignant neoplasms. Treatment of unresectable retroperitoneal lesions requires pathological diagnosis. Here, we report the utility and safety of retroperitoneoscopic biopsy for unresectable retroperitoneal lesions excluding urogenital cancers. METHODS: We analyzed 47 patients consisting of 23 (49%) and 24 (51%) cases that underwent retroperitoneoscopic tissue biopsy and open biopsy, respectively. The clinicopathological features, including postoperative complications, were compared between the two groups. RESULTS: Tumor pathology was diagnosed successfully with a single operation in all patients. Malignant pathology (68%) was more common than benign pathology (32%). The most common pathology was malignant lymphoma, which accounted for about 50% of all cases. There was no significant difference with respect to the age, sex, tumor size, presence of tumor-related symptom, histopathology, operative time, and complications. Three (13%) of 23 patients in the retroperitoneoscopic biopsy group received percutaneous needle biopsy before laparoscopic excisional biopsy because the evaluation of needle cores failed to confirm subclasses of diagnosed pathologies. One patient was converted to open surgery just after the initiation of operation due to severe adhesion of adjacent structures. We had two cases with iatrogenic urinoma due to ureteral injury after retroperitoneoscopic biopsy. CONCLUSIONS: We conclude that retroperitoneoscopic biopsy is a safe and useful tool for benign and malignant retroperitoneal lesions, in comparison to open biopsy. It is critical to carefully examine the preoperative imaging for the location of tumors, especially those close to the renal pelvis and ureter.

[Pubic Bone Osteomyelitis in Patient with Prostate Cancer after Robot-Assisted Laparoscopic Prostatectomy; A Case Report].

A 72-old man had undergone robot-assisted laparoscopic prostatectomy for localized prostate cancer (cT2aN0M0). He was referred to us with a complaint of lower abdominal pain, pain at the bilateral inner thigh, gait disturbance and persistent pyuria three months after surgery. A pelvic MRI revealed inflammation of the pubic area, and pubic bone osteomyelitis was suspected. He was admitted and administered doripenem hydrate (DRPM) intravenously for 3 weeks. The symnptoms of gait disturbance, pain at the bilateral inner thigh, and lower abdominal pain were improved gradually. Levofloxacin hydrate (LVFX）wa s administered orally for 8 weeks subsequently. He has been followed and has had no recurrence of these symptoms.

[Migration of Hem-o-Lok Clips into the Urinary Bladder Used during Robot-Assisted Laparoscopic Prostatectomy].

Recently, robot-assisted laparoscopic prostatectomy (RALP) has become a widely accepted surgical alternative for the treatment of prostate cancer. The intravesical migration of clips is a rare surgical complication of RALP. From March2013 to July 2018, 320 patients underwent RALP at our hospital. Migration of a Hem-o-Lok clip into the urinary bladder occurred in 4 of the 320 patients (1.3%). We analyzed these 4 patients in terms of subjective symptoms, intra- and post-operative findings, site of the migrated clip, and its treatment. The mean duration from RALP to the diagnosis was 13.8 months (2-26 months). The main symptoms due to migrated clips were : narrowed urinary stream, perineal pain, gross hematuria, and painful urination. In all cases, the size of the migrated clip was medium-large, and the events developed on the side contralateral to the first assistant. The clips were transurethrally removed using a Holmium-laser in 2 patients, and spontaneous excretion was observed in 1. The remaining patient has been asymptomatic and is being conservatively observed. In order to prevent the migration of clips used during RALP, the size of the clips and direction of the clip tail may be important. The first assistant should place the clips carefully, especially on the contralateral side.

[Iatrogenic Injuries of Urinary Tract : Outcomes of Surgical Repairs].

Iatrogenic urinary tract injuries are known complications of digestive and pelvic surgeries. We retrospectively reviewed 13 patients with bladder injuries and 16 patients with ureteral injuries requiring surgical repair or stent placement in our hospital between 2013 and 2016. Obstetric-gynecologic surgery accounted for 10 bladder injuries and 11 ureteral injuries on hysterectomy and Cesarean section. Digestive surgery led to 1 bladder injury and 5 ureteral injuries on colon resection, and urologic surgery resulted in 1 injury on biopsy of a retroperitoneal tumor. Regarding bladder injuries, 10 patients underwent cystorrhaphy, and 3 patients received indwelling of a transurethral Foley catheter alone. Concerning ureteral injuries, 7 patients underwent repair of the injured ureter (ureteroneocystostomy in 5, and ureteroureterostomy in 2), and 9 patients received ureteral stent placement after postoperative retrograde urography. Repair failure was defined when urine leakage, urinary fistula, or urinary stricture requiring ureteral stent placement still existed at 90 days after the repair treatment. The bladder injuries in all 13 cases were successfully repaired. The ureteral injury treatments in 7 out of 16 patients (43.8%) were judged as being unsuccessful because of the condition requiring a ureteral stent at 90 days. There was a correlation between the delayed diagnosis of ureteral injury and unsuccessful repair. The present study showed that the prompt identification of urinary tract injuries, especially ureteral injuries, can result in decreased morbidity andsubsequently improved outcomes.

[Robot-Assisted Laparoscopic Prostatectomy for Patient with Hereditary Hemorrhagic Telangiectasia: A Case Report].

A 69-year-old man who had a history of several nasal hemorrhages and transfusions presented with hereditary hemorrhagic telangiectasia. He was referred to the previous hospital due to the elevation of prostate specific antigen (PSA) to 17.2 ng/ml, and was diagnosed with prostate cancer (cT3aN0M0, Gleason 4 + 5). He was referred to our hospital for the treatment of prostate cancer. Contrast lung computed tomography and brain magnetic resonance imaging did not show arteriovenous fistula in either the lung or brain. Upper gastrointestinal endoscopy showed capillary dilatations in the gastric mucosa. Robot-assisted laparoscopic prostatectomy with Trendelenburg position under general anesthesia was performed. Tracheal intubation was made using bronchofiberscopy. A gastric tube was not inserted. Intra- and postoperative course was uneventful, and there has been no elevation of PSA during the eight months followed.

[Bladder Rupture during Intravesical BCG Therapy : A Case Report].

A 69-year-old man received transurethral resection (TUR) ofbladder tumor. The histopathological diagnosis was urothelial carcinoma, high grade, pT1＋pTis. The surgical specimens obtained by second TUR showed no residual malignancy histopathologically. Intravesical Bacillus Calmette-Guerin (BCG) instillation therapy was initiated 2 months after the second TUR. He complained of lower abdominal pain and painful urination on the day following the second instillation of BCG. Computed tomography and cystography demonstrated rupture ofthe urinary bladder. During 2 weeks ofconservative treatment, the symptoms persisted. Then, open repair ofthe bladder was performed. Intravesical BCG therapy has been a widely accepted treatment for bladder cancer with high grade Ta and T1, and carcinoma in situ. In the present case, thinning ofthe bladder wall, delayed wound healing caused by 2 TURs, and abdominal pressure may have been the factors leading to the bladder rupture in addition to inflammation of the bladder due to BCG instillation. Although bladder rupture caused by intravesical BCG therapy has not been reported, we must be aware ofthe possibility ofthis rare condition, especially after 2 consecutive TURs.

[Acute Urinary Retention Caused by Acute Disseminated Encephalomyelitis : A Case Report].

An 11-year-old boy was referred to our department with the chief complaint of acute urinary retention. He had had a history of viral enteritis a few days before the onset of dysuria. He presented with a slight fever, mild headache and weakness of the extremities. A cerebrospinal fluid examination showed the elevation of cell number (cell number : 158/3, polynuclear cells : 29/3, and mononuclear cells : 129/3). Although spinal magnetic resonance imaging (MRI) did not show abnormal findings, fluid attenuated inversion recovery (FLAIR) image of the brain MRI showed a high signal area on the cerebral cortex. Acute disseminated encephalomyelitis (ADEM) was suspected from the clinical course, the cerebrospinal fluid examination, and brain MRI findings. A urethral catheter was indwelled for urinary retention, and steroid pulse therapy was promptly started. After removal of the urethral catheter seven days after the therapy initiation, normal urination without residual urine was observed. Findings of a cerebrospinal fluid test and brain MRI also showed improvement.

[Ureteral Cancer Developing in Retrocaval Ureter : A Case Report].

Ureteral cancer in the retrocaval ureter is rare. We herein report a patient with this condition laparoscopically treated. A 69-year-old man was referred to us because of right ureteral cancer diagnosed during ureteroscopic surgery for a ureteral calculus. Histological diagnosis of the ureteroscopically biopsied material was non-invasive papillary urothelial carcinoma, low grade (G2). Computed tomography (CT) demonstrated a retrocaval ureter : a double J stent placed during ureteroscopy assisted the diagnosis. The patient underwent retroperitoneoscopic complete nephroureterectomy on the right side. Sufficient separation of the right ureter and the inferior vena cava under retroperitoneoscopic procedures facilitated en bloc extirpation of the kidney and ureter with a minimal lower abdominal incision. The surgical procedures for ureteral cancer in the retrocaval ureter, should be preoperatively considered with care.

[Laparoscopic Non-Ischemic Partial Nephrectomy Using a Microwave Tissue Coagulator : A Single-Institutional Study].

We retrospectively investigated the surgical outcomes of renal cell carcinoma (RCC), perioperative complications, and residual renal function in patients receiving laparoscopic non-ischemic partial nephrectomy using a microwave tissue coagulator (MTC). Between January 2002 and December 2015, laparoscopic non-ischemic partial nephrectomy using MTC was performed in 49 patients. The histological diagnosis was RCC in 38 patients, angiomyolipoma in 4, oncocytoma in 2, and others in 5. A histologicallyproven positive surgical margin was observed in 1 (2.0%). Postoperative urine leakage occurred in 1, and it was treated conservatively. The mean follow-up period was 32.0 months. Although there was no patient who died of RCC, local recurrence occurred in 2 patients (4.1%) during the follow-up period. One of these 2 patients had a positive surgical margin. Deterioration of the residual renal function was not observed. Laparoscopic non-ischemic partial nephrectomy using MTC was safe and useful in terms of cancer control and preservation of renal function.

[Investigation of incidence and risk factors of subcutaneous granulomas induced by injection of leuprorelin acetate].

We investigated the incidence of granuloma and its related factors in 180 patients with prostate cancer who showed subcutaneous granuloma formation during androgen deprivation therapy with subcutaneously administered leuprorelin acetate. A granuloma was defined as a persistent induration over 30 mm in diameter in the injected portion. Small indurations which often developed and disappeared after every injection were excluded. The survey was performed using a questionnaire after receiving written informed consent. Among the 180 patients with prostate cancer, 21 (11.7%) developed a granuloma at the injection portion, and subsequently the injection of leuprorelin acetate had to be discontinued. Eighteen of the 21 patients alternatively received goserelin acetate. Three patients had high-grade granulomas with ulcer and abscess formation, and were successfully treated with oral antibiotics. The average duration between the first injection of leuprorelin acetate and granuloma formation was 20.2 months (range : 4 to 62 months). There was no association between granuloma formation and patient backgrounds, such as allergic predisposition and past history. Twenty-one of the 180 prostatic cancer patients developed subcutaneous granuloma induced by the injection of leuprorelin acetate. The investigation showed an unexpectedly high incidence of granuloma formation. We must explain the risk of developing subcutaneous granuloma to the patients before introducing leuprorelin acetate.