Multicenter Phase II Clinical Trial of Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy for Patients With High-Grade Upper Tract Urothelial Carcinoma.

PURPOSE: Neoadjuvant chemotherapy (NAC) has proven survival benefits for patients with invasive urothelial carcinoma of the bladder, yet its role for upper tract urothelial carcinoma (UTUC) remains undefined. We conducted a multicenter, single-arm, phase II trial of NAC with gemcitabine and split-dose cisplatin (GC) for patients with high-risk UTUC before extirpative surgery to evaluate response, survival, and tolerability. METHODS: Eligible patients with defined criteria for high-risk localized UTUC received four cycles of split-dose GC before surgical resection and lymph node dissection. The primary study end point was rate of pathologic response (defined as < ypT2N0). Secondary end points included progression-free survival (PFS), overall survival (OS), and safety and tolerability. RESULTS: Among 57 patients evaluated, 36 (63%) demonstrated pathologic response (95% CI, 49 to 76). A complete pathologic response (ypT0N0) was noted in 11 patients (19%). Fifty-one patients (89%) tolerated at least three complete cycles of split-dose GC, 27 patients (47%) tolerated four complete cycles, and all patients proceeded to surgery. With a median follow up of 3.1 years, 2- and 5-year PFS rates were 89% (95% CI, 81 to 98) and 72% (95% CI, 59 to 87), while 2- and 5-year OS rates were 93% (95% CI, 86 to 100) and 79% (95% CI, 67 to 94), respectively. Pathologic complete and partial responses were associated with improved PFS and OS compared with nonresponders (≥ ypT2N any; 2-year PFS 100% and 95% v 76%, P < .001; 2-year OS 100% and 100% v 80%, P < .001). CONCLUSION: NAC with split-dose GC for high-risk UTUC is a well-tolerated, effective therapy demonstrating evidence of pathologic response that is associated with favorable survival outcomes. Given that these survival outcomes are superior to historical series, these data support the use of NAC as a standard of care for high-risk UTUC, and split-dose GC is a viable option for NAC.

Getting back to work: A framework and pivot plan to resume elective surgery and procedures after COVID-19.

INTRODUCTION: The COVID-19 pandemic has compelled a majority of hospital systems to reduce surgical and procedural volumes in an attempt to preserve resources. Elective surgery and procedures resumption has proven to be a calculated risk between COVID-19 exposure and resource depletion and patient morbidity and mortality from surgical deferral. METHODS: Within a few days of halting elective surgery and procedures, our 7-hospital (2427 in-patient beds, 26,647 inpatient surgeries) healthcare system developed a multidisciplinary Pivot Plan with the primary outcome of a phased resumption of elective surgery and procedures. The plan entailed the integration of our electronic medical record, order entry automatization, perioperative staff utilization, partnering with primary care providers, and a stepwise COVID-19 testing algorithm based on a predetermined hierarchy of case acuity and timeliness of patient care. RESULTS: The Pivot Plan was instituted on May 10, 2020. Since then, 22,624 patients have been tested for COVID-19 in anticipation of an elective surgery and procedures; 140 (0.62%) tested positive for COVID-19 and had their procedure deferred. As our testing capability has increased, we have been able to increase our added elective surgery and procedures capacity from 13 cases per day to 531 cases per day. In turn, we have seen the case volume increase by 52%. CONCLUSION: Our academic healthcare system located in one of the initial COVID-19 hotspots in the United States has successfully resumed elective surgery and procedures in part due to a receptive and supportive culture based upon nimbleness, agility, and rapid integration of multiple resources from a cohort of diverse disciplines applied to the perioperative services workflow.

Adrenal vein sampling with and without cosyntropin stimulation for detection of surgically remediable aldosteronism.

CONTEXT AND OBJECTIVE: Bilateral adrenal vein sampling (AVS), the diagnostic standard for identifying surgically remediable aldosteronism (SRA), is commonly performed after cosyntropin stimulation (post-ACTHstim). The role of AVS without cosyntropin stimulation (pre-ACTHstim) has not been established. The selectivity index (SI), the adrenal vein (av) serum cortisol concentration divided by that in a peripheral vein, confirms av sampling. The minimally acceptable SI is controversial. The objectives of this study were to determine the role of pre-ACTHstim AVS and a predetermined SI. DESIGN: Using biochemical cure as the endpoint, we performed a retrospective head-to-head comparison of pre-ACTHstim AVS to post-ACTHstim AVS. The specificity of a predetermined minimum SI of 1.5 in pre-ACTHstim AVS was determined. PATIENTS: At a regional AVS referral centre, we analysed 32 patients who had undergone simultaneous bilateral AVS both pre- and post-ACTHstim and had returned for postadrenalectomy evaluation. MEASUREMENTS: Simultaneous bilateral AVS was performed with measurements of venous concentrations of aldosterone and cortisol. End points were postadrenalectomy plasma renin activity, serum aldosterone concentration, and number of antihypertensive medications. RESULTS: All 32 patients achieved a biochemical cure following adrenalectomy. The two AVS protocols were complementary. Notably, seven patients (22%; CI = 11-38) were found to have SRA by a lateralization index (LI) > 4 on the pre-ACTHstim AVS, but not on the post-ACTHstim AVS. SI pre-ACTHstim was divided into tertiles. Specificity was 100% in all. CONCLUSIONS: Simultaneous bilateral AVS performed both pre-ACTHstim and post-ACTHstim maximizes SRA identification. A SI of 1.5 pre-ACTHstim does not reduce specificity.

da Vinci Skills Simulator construct validation study: correlation of prior robotic experience with overall score and time score simulator performance.

OBJECTIVE: To assess the construct validity of the da Vinci Skills Simulator (Intuitive Surgical, Sunnyvale, CA). Ideally, a well-designed simulator should demonstrate construct validity, which is defined in this study as the correlation between robotic surgical experience and performance on the simulator. PATIENTS AND METHODS: Thirty-nine surgeons (18 [46%] group I [0-20 robotic cases]; 8 [21%] group II [21-150 robotic cases]; and 13 [33%] group III [>150 robotic cases]) were enrolled from September 2010 to December 2010. Participants completed 24 virtual-reality exercises on the da Vinci Skills Simulator. Data on 12 performance metrics were collected by the software. Overall means for score and time across exercises were analyzed. RESULTS: Overall scores (64.7%/79.1%/87.4%) and time scores (39.1%/58.6%/87.3%) were significantly different among surgeons in groups I-III (P <.001) and demonstrated significant linear relationships (P <.001) for all 24 exercises. Comparisons between the 3 groups using a univariate general linear model (GLM) was used to compare groups I and II and II and III. Groups I and II differed using overall score for 15 exercises and time score for 11 exercises. Groups II and III differed using overall score for 6 exercises and time score for 15 exercises. Mean overall score for 1 exercise displayed significance between both groups I and II and II and III; while using time score, 5 exercises displayed significance between surgeons in groups I and II and II and III. CONCLUSION: Initial construct validity analysis revealed that both overall scores and time scores showed a significant linear relationship when comparing the surgeons in groups I, II, and III. Overall score seems to be a stronger indicator for differences between surgeons in groups I and II. Time score seems to be a stronger indicator for differences between surgeons in groups II and III.

Skill based mentored laparoscopy course participation leads to laparoscopic practice expansion and assists in transition to robotic surgery.

PURPOSE: Prior studies suggest poor long-term incorporation of laparoscopy into urology practice after a postgraduate course. We evaluated the influence of the American Urological Association Mentored Laparoscopy Course on urologist clinical practice. MATERIALS AND METHODS: The 2-day Mentored Laparoscopy Course includes lectures, standardized dry laboratory training with videotape analysis and a porcine laboratory with consistent mentors. Surveys to assess the impact of the course were sent in April 2010 to the 153 urologists who had taken the course from 2004 through 2009. RESULTS: Of the 153 surveys 91 (60%) were returned a mean of 34.5 months after completing the course. Of the respondents 82% were in a group private practice, followed by solo private practice (15%) and full-time academic practice (3%). Of the respondents 92% reported that they had sutured laparoscopically, 52% had sutured a bleeding vessel and 51% had performed reconstructive laparoscopy since taking the course. Of the respondents 77% reported that their laparoscopic practice had expanded since taking the course (mean 2.9 cases monthly). Of the 41 respondents (45%) who now performed robotic surgery (mean 3.8 cases monthly) 39 (95%) thought that the course experience had helped with the transition into robotic surgery. Overall survey respondents were pleased with the experience during the course with 89 of 91 (98%) stating that they would recommend the course to a colleague. CONCLUSIONS: Long-term results reveal that the American Urological Association Mentored Laparoscopy Course attendees reported expansion in their laparoscopic practice since taking the course. They described the course as benefiting the transition to robotic surgery.

Does prior abdominal surgery influence outcomes or complications of robotic-assisted laparoscopic radical prostatectomy?

OBJECTIVES: To determine whether robotic-assisted laparoscopic radical prostatectomy (RALP) in patients with prior abdominal surgery is associated with increased operating times, positive surgical margins, or complications. METHODS: An institutional review board-approved retrospective review of a prospective, prostatectomy database was performed. Patients undergoing surgery between January 1, 2004, and February 29, 2008 were included. Transition from open retropubic prostatectomy to RALP took place through 2004, at which point all surgical candidates were offered RALP, regardless of prior surgical history. Learning curves from all surgeons were included. Patients with prior abdominal surgery were compared with those patients without prior surgery with respect to total operating time, robotic-assist time, surgical margin positivity, and rate of complications. RESULTS: A total of 1083 patients underwent RALP between January 1, 2004, and February 29, 2008, at our institution; of these, 839 had sufficient data available for analysis. In all, 251 (29.9%) patients had prior abdominal surgery, whereas 588 (70.1%) had no prior abdominal surgery. Total operating times were 209 and 204 minutes (P = .20), robotic console times were 165 and 163 minutes (P = .59), and surgical margin positivity was 21.1% and 27.2% (P = .08) for patients with and without prior abdominal surgery, respectively. The incidence of complications was 14.3% and 17.3% for patients with and without prior abdominal surgery (P = .33). CONCLUSIONS: Prior abdominal surgery was not associated with a statistically significant increase in overall operating time, robotic assist time, margin positivity, or incidence of complications in patients undergoing RALP. Robotic prostatectomy can be safely and satisfactorily performed in patients who have had a wide variety of prior abdominal surgery types.

Skills-based laparoscopy training demonstrates long-term transfer of clinical laparoscopic practice: additional follow-up.

OBJECTIVES: The American Urological Association Hands on Laparoscopy course was designed to help practitioners without laparoscopic training advance their skills. We evaluated the long-term effect of this course on urologists' practice. METHODS: A total of 52 urologists, 37-61 years old (mean 50.7), participated in one of three courses given from August 2002 to October 2003. The 2-day course included performing standardized tasks with videotape analysis and participating in porcine and pelvic trainer laboratory sessions with intense mentoring from known experts. Surveys were sent by regular and electronic mail in February 2007 to assess the effect of the course. The mean follow-up was 48 months (range 41-55). RESULTS: Of the 52 surveys mailed, 32 were returned (61%). Most respondents were in private practice and had previous experience with extirpative urologic laparoscopy. Of the 32 respondents, 31 (97%) reported that their laparoscopic practice had expanded after taking the course. Also, 24 (75%) reported having sutured laparoscopically after taking the course, with 61% having sutured a bleeding vessel, and 80% reported that the video mentoring during the course was helpful. Of those who purchased a pelvic trainer, 90% reported practicing on it regularly. CONCLUSIONS: The results of our study have shown that the Hands on Laparoscopy course has a significant long-term (mean 48 months) effect on the laparoscopic practice of course alumni. The experience gained from skills-based lectures, videotape analysis of pelvic trainer performance, and a mentored porcine laboratory session resulted in most participants expanding their practice (97%) and suturing laparoscopically (75%).

Survey from skills-based hands on learning courses demonstrates increased laparoscopic caseload and clinical laparoscopic suturing.

OBJECTIVES: To evaluate the impact of the American Urological Association Hands on Laparoscopy course on the participants' practices. Many urologists without fellowship training perform laparoscopy, but do not advance beyond hand-assisted, extirpative laparoscopy. The American Urological Association Hands on Laparoscopy course was designed to help these practitioners advance their skills. METHODS: A total of 68 urologists, aged 31 to 61 years (mean 46.6), participated in one of the four courses given between August 2002 and March 2004. The 2-day course included performing standardized tasks under videotape analysis and participating in porcine and pelvic trainer laboratory sessions. Surveys were sent by regular and electronic mail in September 2004 to assess the courses' impact. The mean follow-up was 15.2 months (range 7 to 25). RESULTS: Of the 68 surveys mailed, 54 were returned (79%). Most respondents were in private practice and had had prior experience with extirpative laparoscopy. Of the respondents, 41 (76%) reported that their laparoscopic practice had expanded after taking the course, with 34% performing at least 2 cases per month. Also, 33 respondents (61%) reported performing laparoscopic suturing after taking the course, with 35% having sutured a bleeding vessel. Of the respondents, 85% reported that the video mentoring during the course was helpful. Of those who purchased a pelvic trainer, 90% reported practicing on it regularly. CONCLUSIONS: The Hands on Laparoscopy course appeared to contribute to expansion of laparoscopic practices. Experience gained from skills-based lectures, videotape analysis of pelvic trainer performance, and a mentored porcine laboratory resulted in most (61%) participants expanding their practice to include clinical laparoscopic suturing.

Expert videotape analysis and critiquing benefit laparoscopic skills training of urologists.

INTRODUCTION: Teaching laparoscopic skills has become the focus of the latest generation of hands-on laparoscopic courses. METHODS: Thirty-four practicing urologists, ages 31 to 61 years (mean, 46.6 years) with laparoscopic experience (range, 0 to 200, mean, 27.6 cases), 32 of whom had taken prior American Urological Association (AUA) laparoscopy courses, participated in an AUA-sponsored hands-on laparoscopic skills course over a 2-day period in August 2002 or March 2003. They all took a knowledge assessment examination and performed standardized tasks (rope passing, ring placement, and laparoscopic suturing and knot tying) at the beginning and the end of the course with a videotape analysis and critique. Prior to the repeat-skills assessment, each participant was individually critiqued and instructed based on a videotape review of their initial performance. The urologists also participated in a porcine laboratory and a pelvic trainer session totaling 6 hours between skills assessments. None of the participants had performed significant laparoscopic suturing prior to the course. RESULTS: Using Wilcoxon's signed rank test, the participants improved from a mean of 119.32 seconds to 98.36 seconds with the rope pass (P = 0.0001), and with the ring placement from a mean of 9.70/minute to 12.09/minute (P = 0.0001). All participants had significantly fewer false passes (mean, 9.35 compared with 5.21) during repeat skills assessments (P = 0.0001). Participants improved from 0.54 sutures/minute to 1.22 sutures/ minute following the video critique and practice (P = 0.0001). Degree of laparoscopic experience (number of cases), age of the urologist, and precourse knowledge (examination score) had no significant bearing on results in the initial skills assessment or in the improvement of task time (Spearman correlation coefficients). CONCLUSION: Urologists with some laparoscopic experience (mean 27.6 cases) can improve laparoscopic skills using mentored videotape analysis and experience gained from a 2-day hands-on course. Prior knowledge, degree of experience, and urologist age had no significant bearing on performance in this setting.

Hand-assisted laparoscopy for large renal specimens: a multi-institutional study.

OBJECTIVES: To present our experience with hand-assisted laparoscopy (HAL) for larger renal specimens. One of the theoretical benefits of HAL is the ability to manage large renal specimens, which we defined as tumors greater than 7 cm, and tumors in obese patients. METHODS: Between March 1998 and October 2000, 106 HAL radical nephrectomies were performed for enhancing renal masses, for which 95 patients had complete preoperative, intraoperative, and postoperative data. Of the 95 patients, 32 underwent HAL for large tumors (7 cm or greater) and 41 had a body mass index of 31 or greater. The demographic and outcome data of these two groups were compared with 63 patients who underwent HAL for tumors less than 7 cm and 54 patients with a body mass index of less than 31. RESULTS: When comparing cohorts by tumor size, the only statistically significant differences were in convalescence and specimen weight. Patients with lesions 7 cm or greater required 21 days to recover compared with 18 days for patients with lesions less than 7 cm. Obese patients had statistically significantly higher American Society of Anesthesiologists classifications, longer operative times (214 versus 176 minutes), and longer convalescences (21 versus 17.5 days) compared with nonobese patients. The estimated blood loss and conversion rate was not different between the groups. Furthermore, no difference was noted between the groups in the incidence of positive margins, local recurrence, or metastatic recurrence at a mean follow-up of 12.2 months. CONCLUSIONS: HAL provides a safe, reproducible, and minimally invasive technique to remove large renal tumors and renal tumors in the obese.

Laparoscopic adrenalectomy: the New York-Presbyterian Hospital experience.

BACKGROUND AND PURPOSE: Laparoscopic adrenalectomy has become the standard technique for the surgical removal of the adrenal gland. The advantages of the laparoscopic approach include shorter length of stay (LOS), a decrease in postoperative pain, faster return to preoperative activity level, improved cosmesis, and reduced complications. We report our experience with laparoscopic adrenalectomy via a lateral transperitoneal approach. PATIENTS AND METHODS: Between September 1993 and April 2001, we performed 100 lateral transperitoneal adrenalectomies in 91 patients. In 82 cases, the adrenalectomy was unilateral and in the other 9, it was bilateral. A total of 59 left-sided lesions and 41 right-sided lesions were removed. The indications for surgery were Cushing's syndrome (24), aldosteronoma (34), pheochromocytoma (17), nonfunctioning adenoma (13), Carney's syndrome (1), and a metastasis from colon cancer (1) RESULTS: The overall success rate was 98%. Complications occurred in the two patients who required open conversion. In addition, three patients suffered pneumothoraces because of direct iatrogenic injury to the diaphragm during laparoscopic dissection. One additional patient suffered a splenic laceration. Operative time, blood loss, and intraoperative complications were similar in the laparoscopic and open surgery control group (N = 32). CONCLUSIONS: Laparoscopic adrenalectomy is technically feasible and reproducible. The lateral transperitoneal technique offers distinct advantages to the laparoscopist, including better visibility of familiar anatomic landmarks, easy access to other organ systems, the use of gravity to retract the spleen and liver, and a wide exposure, which allows removal of large adrenal lesions.

Laparoscopic resection of large adrenal tumors.

BACKGROUND: The maximum size of adrenal tumors that should be removed with a laparoscopic approach is controversial. It has been suggested that laparoscopic adrenalectomy is appropriate only for adrenal tumors < 6 cm in size. We report our experience with laparoscopic adrenalectomy in patients with adrenal tumors of > or =6 cm compared with patients with smaller tumors. METHODS: We retrospectively reviewed a consecutive series of patients who had a laparoscopic adrenalectomy. Patients were considered candidates for laparoscopic adrenalectomy if their computed tomography (CT) scan showed a well-encapsulated tumor confined to the adrenal gland. RESULTS: Sixty laparoscopic adrenalectomies were performed in 53 patients. Twelve of the adrenalectomies (20%) were for tumors that were > or =6 cm (median, 8 cm; range, 6 to 12 cm). There have been no local or regional recurrences, but one patient with adrenocortical carcinoma developed pulmonary metastases. When the 12 patients with large tumors were compared with the 36 patients with tumors < 6 cm, the median operative time (190 vs. 180 minutes; P =.32), operative blood loss (100 vs. 50 mL; P =.53), and postoperative hospital stay (2 vs. 2 days; P = 1.0) were similar. CONCLUSIONS: The size of an adrenal tumor should not be the primary factor in determining whether a laparoscopic adrenalectomy should be performed. Large adrenal tumors that are confined to the adrenal gland on CT can be removed with a laparoscopic approach.