Pietro Cortellini

An Open, Randomised, Multicentre, Phase 3 Trial Comparing the Efficacy of Two Tamoxifen Schedules in Preventing Gynaecomastia Induced by Bicalutamide Monotherapy in Prostate Cancer Patients

BACKGROUND Bicalutamide monotherapy is a valuable option for prostate cancer (PCa) patients who wish to avoid the consequences of androgen deprivation; however, this treatment induces gynaecomastia and mastalgia in most patients. Tamoxifen is safe and effective in preventing breast events induced by bicalutamide monotherapy without affecting antitumor activity, but possible interference between bicalutamide and tamoxifen remains a matter of concern. To reduce the exposure to tamoxifen, we considered the putative advantages of weekly administration. OBJECTIVE To compare the efficacy of two different schedules of tamoxifen in preventing breast events. Toxicity, prostate-specific antigen behaviour, and sexual-functioning scores were also evaluated. DESIGN, SETTING, AND PARTICIPANTS This was a noninferiority trial. From December 2003 to February 2006, 80 patients with localised/locally advanced or biochemically recurrent PCa who were also candidates for bicalutamide single therapy were randomised to receive two different schedules of tamoxifen: daily (n=41) and weekly (n=39). Median follow-up was 24.2 mo. INTERVENTION Daily bicalutamide (150 mg) plus daily tamoxifen 20mg continuously (daily group) or the same but with tamoxifen at 20mg weekly after the first 8 wk of daily treatment (weekly group). Three patients in the weekly group and one in the daily group were discontinued for adverse events. MEASUREMENTS For gynaecomastia, we used ultrasonography. For mastalgia and sexual functioning, we used questionnaires. RESULTS AND LIMITATIONS Gynaecomastia developed in 31.7% of patients in the daily group and in 74.4% of patients in the weekly group (p<0.0001), and it was more severe in patients who switched to weekly tamoxifen (p=0.001). Mastalgia occurred in 12.2% and 46.1% of patients, respectively (p=0.001). There were no major differences among treatment schedules relative to sexual functioning scores and incidence and severity of adverse events. No differences between groups in PSA behaviour and disease progression have been detected so far. CONCLUSIONS This study demonstrated that tamoxifen 20mg/wk is inferior to tamoxifen 20mg/d in preventing the incidence and severity of bicalutamide-induced breast events. The safety and efficacy of tamoxifen at the common daily dose of 20mg for the prophylaxis of bicalutamide-induced breast events were confirmed.

Massive hematuria after transurethral resection of the prostate: Management by intra-arterial embolization

A case of severe hemorrhage after TURP leading to hypovolemic shock and its successful management by superselective unilateral arterial embolization is described. The authors conclude that arterial embolization is a safe and effective procedure for severe prostatic hemorrhage that may be performed in selected cases when conservative means or fulguration of the prostatic fossa have failed to achieve the control of the bleeding. Adequate selection of the patients, correction of any underlying coagulation defects and a proper resection technique are surely the most important issues in preventing any postoperative bleeding.

Histological Adaptation of Orthotopic Ileal Neobladder Mucosa: 4-Year Follow-Up of 30 Patients

Objective: For 4 years we have monitored the histological evolution of ileal neobladders in a single cohort of 30 patients in order to systematically describe the histological changes occurring after surgery. The aim of the study was to evaluate the long-term evolution of many histological parameters with functional relevance as to the metabolic outcome of the reservoirs. Methods: Ileal samples were collected during surgery and by random biopsies during cystoscopy 6, 12, 18, 24, 36 and 48 months later. At each step qualitative and quantitative assessment of the histological and cytological conditions of the samples was carried out. Results: Morphological changes develop relatively early but the situation tends to level out in about 1 year. The morphological changes are topographically uneven and, although mucosal flattening becomes progressively prevalent, areas with shortened villi persist indefinitely. Goblet cells prevail over enterocytes and the secretive pattern shifts towards sialomucins. The overall replication rate decreases initially but tends to restore in 1 year. Dysplasia or atrophy were never recorded. Conclusions: The 4-year systematic follow-up revealed a typical histological adaptation pattern in the ileal neobladder without signs of dysplasia. The changes seem to be induced by the aggressive environment and develop in the time lag required for functional adaptation of the epithelium.

Primary bilateral seminal vesicle carcinoma: description of a case and literature review.

With no more than 60 reported cases, tumors of the seminal vesicles are rare. Because of poor and nonspecific symptoms diagnosis is often very difficult. This report presents a case of a 56-year-old man with right renal agenesis and intermittent hematospermia and bilateral cystic masses of the seminal vesicles. Transrectal biopsies of the cystic lesion revealed a papillary clear cell adenocarcinoma. The patient underwent radical prostatectomy and pelvic lymphoadenectomy. Lymph node metastases were found on histological examination. The patient received 4 cycles of chemotherapy and pelvic radiotherapy. He remains disease free 21 months after surgery. Radiological imaging in patients with hematospermia and hematuria will allow disease detection at earlier stages. Immunohistochemistry and histomorphology can be used for differential diagnosis. Surgery with clear margins offers the best chance to cure. Hormonal and radio-chemotherapy have a role as adjuvant and palliative treatment.

Is laparoscopy contraindicated in giant adrenal masses

The first laparoscopic adrenalectomy was performed and described by Gagner in 1992. Since then, this technique has become more and more widespread and there is common agreement in the literature that it is the gold standard for adrenalectomy. Laparoscopic adrenalectomy is indicated in benign adrenal masses, and it is routinely performed in masses smaller than 5 to 7 cm. The laparoscopic procedure in masses larger than this cut-off is discussed, although many investigators agree about its feasibility, safety and effectiveness. We present this case: man, 39 years old, large palpable mass in the right hypochondrium. Computed tomography scan (CT) suggested the diagnosis of giant adrenal myelolipoma (15×12×7 cm). Complete adrenal endoclinologic evaluation showed that the lesion was not a secreting tumor. Laparoscopic adrenalectomy was performed with good results.

Thrombosed aneurysm of a segmental renal artery branch. Diagnostic and therapeutic approach

Introduction We present the case of a 37-year-old man with a thrombosed aneurysm of a segmental branch of the left renal artery, which was diagnosed after a radiological investigation for colic-like pain, and treated conservatively with endovascular approach. Materials and Methods After repeated episodes of colic-like pain in his left side with normal ultrasound of the urinary tract, A.R. (37 years old) undergoes a CT urogram of the abdomen, which shows a complete thrombosis of the middle third of the left renal artery, which is associated with hypoperfusion of the lower middle third of the kidney with suspected ischemia of the lower pole. In confirmation of the previous clinical scenario, we proceed with a urgent angiography, which identifies a pseudoaneurysm, partially thrombosed, of the segmental branch of the left renal artery at the lower middle pole. During the hospitalization, the clinical picture is complicated by an unstable arterial hypertension associated with headache and nausea. A renal scintigraphy confirms a severe impairment of the renal function mainly at the level of the middle third of the lower left kidney. The total glomerular filtration rate sec. Gates was equal to 64.3 mL/min with a percentage breakdown of the global renal function of 28% to the right and 72% to the left. The location of the vascular defect argues for endovascular intervention in the attempt to preserve the remaining renal parenchyma. We proceed with a standard angiography with selective access to the left renal artery with a catheter via femoral artery Cobra 5Fx80 TERUSMO cm. The tortuosity of the thrombus and the angle of the aneurysm site prevent, despite several attempts, the passage of the guide wire for a possible stenting and fibrinolysis. We opt for the placement of 5 spirals at the aneurysm (Boston Soft GDC-10 SR 360 7mm x 15cm), in order to preserve the residual parenchyma, excluding the aneurysmal artery at risk of rupture and extent of the thrombus. Results Immediately after the procedure, the clinical picture remained stable with complete remission of painful symptoms and with a good blood pressure control. At about 6 months, the renal scintigraphy shows a filtered global impairment of 70%, 30% for the left kidney, a slight improvement over the previous controls. The blood pressure remains within the limits with amlodipine 5 mg. Conclusions Renal artery aneurysms are uncommon and occur in approximately 0.09% of the general population. The etiopathogenesis at a young age is often dysplastic in nature and the diagnosis is made incidentally or during evaluation of related symptoms, being asymptomatic until they become complicated. Their treatment is proposed to prevent complications such as rupture or thrombosis. Given the extreme variability of presentation, the surgical technique, traditional or endoscopic, is at the surgeons discretion. In our case, we opted for a conservative approach since the degree of renal parenchyma impairment and the patients hemodynamic condition allowed to.

Laparoscopic adrenalectomy in giant masses

Background Laparoscopic adrenalectomy is considered the treatment of choice in the surgical management of the most majority of the adrenal diseases. Nevertheless, one of the much discussed topics is the dimensional cut-off for the laparoscopic treatment and it is not clear if laparoscopy should be used in large adrenal masses. Introduction Laparoscopic adrenalectomy is the goal standard in benign adrenal masses smaller than 6 cm, while its advantages in masses larger than this cut-off and in malignant lesions is still discussed. Materials and Methods We present six cases of laparoscopic adrenalectomy since November 2008 for masses between 7 and 15 cm; 4 men and 2 women. 3 right and 3 left. A complete adrenal endocrinological evaluation demonstrated that the lesions were not secreting tumors. All patients were studied with CT scan. The technique was performed using a flank approach with a 45° tilt. We used 5 trocars in patients who had the masses on the right side, and 4 in those who had the lesions on the left side. After creating an adequate pneumoperitoneum through an open access, the posterior peritoneum cutting, mobilization of the colon, medial dissection of the adrenal gland, and ligation of the main adrenal vein were performed. The adrenal gland was carefully dissected by Ultracision. The mass was extracted by endobag through an additional subcostal port. The mean operative time was 120 minutes. Blood loss was about 50 cc. The drainage was removed on day 2 after surgery and the patient was discharged on day 3. No post-operative complication occurred. The anatomopathologic exam gave evidence of myelolipoma and hemorrhagic cyst. Discussion The benefits of the laparoscopic approach are widely demonstrated and consist of a shorter hospital stay, reduced morbility decreased analgesic requirement, and reduced intraoperative blood loss. One of the most discussed topics is the dimensional cut-off and it is not clear if the laparoscopy approach should be used in large adrenal masses (considering the longer operative time and increasing blood loss). Many surgeons performed laparoscopic adrenalectomy for masses of up to 13 cm, thus demonstrating that this procedure is safe and effective. A limitation of laparoscopic approach for adrenal giant masses is the increased risk to treat an adrenal cortical carcinoma. Conclusions Our experience, supported by the literature, demonstrates that the laparoscopic adrenalectomy is a feasible and effective surgical technique also in the case of giant masses. Preoperative diagnosis has a predominant role to determine the contraindication of this technique (invasive adrenal carcinoma).

Are Nephroenteric Fistulas Only a Surgical Trouble

Nephroenteric fistulas can be secondary to different etiologies, the most common of which are pyelocolic fistulas. The absence of pathognomonic symptoms and the heterogeneity of presentation can sometimes result in a delay in diagnosis. We report on three cases: a pyelo-duodenal fistula secondary to kidney stones and subsequent pyonephrosis, a pyelocolic fistula due to inveterate ureteral stones with hydropyonephrosis, and a rare case of posttraumatic pyelocolic fistula. All patients were treated with radical nephrectomy and resection of the involved intestinal tract. Fistulas of the kidney with the gastrointestinal tract are complex not only for the surgical treatment, which is mandatory in the majority of cases, but also for clinical and instrumental diagnosis. Severe infection is a major concern due to the admixture of the enteric bacterial flora with the urinary tract. Nephroenteric fistulas require skilled surgical procedures, close control of the septic risk, management of patients overall medical condition, and balance between invasive and conservative approach.

Renal and ureteral stones in V.A.C.T.E.R.L. association: endourological management

Background The endourological technique is a safe and effective approach in the treatment of large stones in the pediatric population with congenital malformations. Introduction The VACTERL association is a group of congenital malformations that include vertebral defects, anal atresia, cardiac defects, tracheoesophageal fistula with atresia, renal defects, and radial upper limb dysplasia. Renal anomalies are found in approximately 90% of patients. Materials and Methods We present a case of a 7-year-old girl with VACTERL association and cloacal malformations, undergoing multiple surgeries with subsequent Mitrofanoff continent appendico-vesicostomy. She presented at our attention for centimetric left ureteral and inferior pyelo-calyceal stones. She underwent flexible ureteroscopy with laser lithotripsy of both stones. A ureteral catheter and a nephrostomy tube have been left at the end of the procedure. Results The ureteral catheter was removed in the 2nd post-operative day, the tubes were removed after a nephrostogram in the 8th post-operative day. The patient is stone-free. No complications were observed in the post-operative time. Conclusions Endoscopy is the method of choice for the management of pediatric urolithiasis with complex renal calculi, due to its low incidence of major complications and a high stone-free rate.BACKGROUND The endourological technique is a safe and effective approach in the treatment of large stones in the pediatric population with congenital malformations. INTRODUCTION The VACTERL association is a group of congenital malformations that include vertebral defects, anal atresia, cardiac defects, tracheoesophageal fistula with atresia, renal defects, and radial upper limb dysplasia. Renal anomalies are found in approximately 90% of patients. MATERIALS AND METHODS We present a case of a 7-year-old girl with VACTERL association and cloacal malformations, undergoing multiple surgeries with subsequent Mitrofanoff continent appendico-vesicostomy. She presented at our attention for centimetric left ureteral and inferior pyelo-calyceal stones. She underwent flexible ureteroscopy with laser lithotripsy of both stones. A ureteral catheter and a nephrostomy tube have been left at the end of the procedure. RESULTS The ureteral catheter was removed in the 2nd post-operative day, the tubes were removed after a nephrostogram in the 8th post-operative day. The patient is stone-free. No complications were observed in the post-operative time. CONCLUSIONS Endoscopy is the method of choice for the management of pediatric urolithiasis with complex renal calculi, due to its low incidence of major complications and a high stone-free rate.

Multiple stones in atypical heterotopic reservoir in a patient with renal transplant: endourologic resolution

Background Urolithiasis is a frequent complication in a heterotopic reservoir and the surgical management could be a difficult problem. Open surgery is not recommended in patients with multiple previous surgeries. A less invasive technique, such as the endourologic procedures, would allow high stone-free rate and low surgical morbidity. Introduction Stone formation in the reservoir is a well-known complication of urinary diversion. The incidence of lithiasis in patients with continent urinary diversion is reported as 12–52.5%. Most patients will have multiple physical factors, such as immobility, need for self-catheterization and poor urine drainage, so that it is not certain that an intestinal reservoir is the cause of stones on its own. The management of urolithiasis in continent urinary diversion can be challenging and could be a difficult problem to solve. A less invasive technique, such as the endourologic procedures, is desiderable, especially in patients with kidney transplant and low immune defence. Materials and Methods We present the case of a 59-year-old woman with previous history of spina bifida and with neurogenic bladder. At a pediatric age, she underwent incontinent urinary diversion using a sigmo-colic conduit. For several years she had been suffering from kidney stones and recurrent urinary infections, which led to a left nephrectomy for pyonephrosis, subsequent deterioration of renal function and dialysis. In 2004, we performed an atypical continent and self-catheterizable reservoir using the previous colic conduit detubularized and ileum-cecal tract with Mitrofanoff system conduit of 14 Fr size. Finally, kidney transplant was carried out as last surgical procedure. Recently she has come to our attention for multiple and large reservoir stones. Surgical Technique preliminary exploration of the continent pouch with flexible cystoscope. Percutaneous access with Endovision° direct control through the afferent conduit with 8 Fr flexible ureteroscope. Dilation of percutaneous tract with pneumatic baloon and positioning 30 Fr Amplats sheet. Lithotripsy, with ultrasound and ballistic sources, was performed and the residual fragments were removed with grasping. At the end of the procedure, after controlling the complete clearance with flexible nephroscope and X-ray a percutanous 12 Fr catheter and a 12 Fr Foley in the Mitrofanoff conduit were inserted. Results No fever or increase serum creatinine were observed in the post-operative time. On day 3, we removed the percutaneous foley and after 7 days we performed a cystography with a normal pouch configuration; no leakage or residual fragments were observed. The woman was discarge and returned to usual self-catheterization. The first 3-month post-operative control was regular; no infections or pain were reported. Conclusions In special cases, like this one, the percutaneous procedure is preferred to open surgery for a best control of the pouch and a simple complete clearence of the fragments.