ABSTRACT
BACKGROUND@#LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.@*METHODS@#We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.@*RESULTS@#On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).@*CONCLUSION@#LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.@*TRIAL REGISTRATION@#ClinicalTrials.gov, NCT04563936.
Subject(s)
Humans , Male , Antineoplastic Agents, Hormonal/therapeutic use , East Asian People , Gonadotropin-Releasing Hormone/agonists , Goserelin/therapeutic use , Prostate-Specific Antigen , Prostatic Neoplasms/drug therapy , TestosteroneABSTRACT
Objective: To evaluate the therapeutic effects of visual standard channel combined with F4.8 visual puncture super-mini percutaneous nephrolithotomy [SMP] on multiple renal calculi
Methods: The clinical data of 46 patients with multiple renal calculi treated in Affiliated Hospital of Hebei University from October 2015 to September 2016 were retrospectively analyzed. There were 28 males and 18 females aged from 25 to 65 years old, with an average of 42.6. The stone diameters were 3.0-5.2 cm, [4.3 +/- 0.8] cm on average. F4.8 visual puncture-assisted balloon expansion was used to establish a standard channel. After visible stones were removed through nephroscopy combined with ultrasound lithotripsy, the stones of other parts were treated through F4.8 visual puncture SMP with holmium laser. Indices such as the total time of channel establishment, surgical time, decreased value of hemoglobin, phase-I stone clearance rate and surgical complications were summarized
Results: Single standard channel was successfully established in all cases with the assistance of F4.8 visual puncture, of whom 24 were combined with a single microchannel, 16 were combined with double microchannels, and six were combined with three microchannels. All patients were placed with nephrostomy tube which was not placed in the microchannels. Both F5 double J tubes were placed after surgery. The time for establishing a standard channel through F4.8 visual puncture was [6.8 +/- 1.8] min, and that for establishing a single F4.8 visual puncture microchannel was [4.5 +/- 0.9] min. The surgical time was [92 +/- 15] min. The phase-I stone clearance rate was 91.3% [42/46], and the decreased value of hemoglobin was [12.21 +/- 2.5] g/L. There were 8 cases of postoperative fever which was relieved after anti-inflammatory treatment. Four cases had 0.5-0.8 cm of stone residue in the lower calyx, and all stones were discharged one month after surgery by in vitro shock wave lithotripsy combined with position nephrolithotomy, without stone streets, delayed bleeding, peripheral organ damage or urethral injury
Conclusion: Combining visual standard channel with F4.8 visual puncture SMP for the treatment of multiple renal calculi had the advantages of reducing the number of large channels, high rate of stone clearance, safety and reliability and mild complications. The established F4.8 visual puncture channel was safer and more accurate
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Kidney Calculi/surgery , Nephrolithotomy, Percutaneous/standards , Retrospective StudiesABSTRACT
Objective: To compare the therapeutic effects of visual standard channel combined with visual superfine precision puncture channel or super-mini percutaneous nephrolithotomy [PCNL] on multiple renal calculi
Methods: A total of 86 patients with multiple renal calculi were retrospectively analyzed. According to different working channels, they were divided into a visual puncture channel group [visual puncture standard channel combined with visual superfine precision puncture channel, n=38] and a conventional puncture channel group [standard channel combined with super-mini channel, n=48]. The two groups were compared in terms of time of channel establishment, surgical time, reduction of hemoglobin, phase I clearance rate of calculi, and surgical complications
Results: The time of establishing visual/conventional standard channel was [4.5+/-1.5] min vs. [6.8+/-1.8] minutes [t=6.326, P=0.000], and the time of establishing visible superfine/super-mini channel was [4.52+/-0.97] minutes vs. [7.76+/-1.35] minutes [t=2.017, P=0.000]. The surgical time was [92+/-15] minutes vs. [115+/-13] minutes [t=26.640, P=0.000]. The Phase-I clearance rate was 86.7% [33/38] vs. 87.5% [42/48] [?2=0.008, P=0.928], the reduction of hemoglobin was [12.21+/-2.5] g/L vs. [13.22+/-3.5] g/L [t=2.017, P=0.137], the blood transfusion rate was 13.16 [5/38] vs. 8.33% [4/48] [?2=0.006, P=0.941], the postoperative fever rate was 7.89% [3/38] vs. 14.58 [7/48] [?2=0.006, P=0.941], and the hospitalization stay length was [6.5+/-1.0] vs. [6.6+/-1.2] [t=0.413, P=0.681]. There were no significant differences between the two groups
Conclusion: Both surgical approaches had high clearance rates of multiple renal calculi, safety, reliability and few complications. However, compared with the conventional puncture channel, the visual one was easy to operate and dramatically shortened the time of establishment, thus being safer and more accurate
ABSTRACT
Objective To evaluate the efficacy and safety of percutaneous micro-channel approach in treatment of pelvis side cyst and ureteropelvic junction obstruction simultaneously. Methods 32 patients with unilateral solitary parapelvic cyst complicated with UPJO, including 25 cases with ipsilateral kidney stones. After percutaneous holmium laser lithotripsy for patients complicated with calculi, then performed incision and drainage through the channels for parapelvic cyst by holmium laser, and antegrade high pressure balloon dilatation for UPJO, drainage by hippocampal tube in 3 ~ 6 months postoperatively. The operation time of fenestration drainage of cyst, narrow hypertensive dilatation and postoperative hospital stay were analyzed. Results Compared with 1 month (46.17 ± 6.33), 3 months (40.47 ± 6.06), 6 months (33.81 ± 7.05), 9 months (28.95 ± 7.92) after surgery, there was a marked improvement of the separation coefficient of renal convergence, the difference was statistically significant (P < 0.05). And compared with 6 months after surgery, the data of 9 months after surgery has statistical significant differences (P < 0.05). The separation coefficient of renal convergence decreases as time goes on. Conclusions Percutaneous micro-channel approach in treatment of pelvis side cyst and ureteropelvic junction obstruction by the same time can effectively relieve symptoms and decrease the separation coefficient of renal convergence. It is safe and effective.
ABSTRACT
Objective To evaluate the safety and effectiveness of modular flexible ureteroscope combined with holmium laser lithotripsy in treatment of bilateral renal calculi smaller than 1.5 cm. Methods Clinical data of 24 patients from August 2013 to March 2016 using a modular flexible ureteroscope in treatment of bilateral renal calculi smaller than 1.5 cm was retrospectively analyzed. The clinical data included operation time, stone clearance rate and occurrence of complications. Results All the 24 patients were successfully placed in bilateral ureteral sheath soft lenses, and enter lithotripsy smoothly. The operation time was 40~105 (71.0 ± 21.5) min. Lithotripsy success rate was 100.00% and 1 month stone clearance rate was 89.50% (43/48), 5 sides with residual stones diameter 7~10 mm, were given extracorporeal shock wave lithotripsy, 3 months stone clearance rate was 93.75% (45/48), 3 sides with residual stones 5~7 mm located lower calyx accepted regular review. 4 cases with postoperative fever were cured after anti-inflammatory treatment. There was no bleeding, ureteral perforation, postoperative avulsion, renal dysfunction, septic shock and other complications. Conclusion Modular flexible ureteroscope lithotripsy in treatment of bilateral renal calculi smaller than 1.5 cm is safe and effective.
ABSTRACT
Objective To investigate the clinical efficacy and safety of visual standard channel combined with visual ultrafine channel PCNL precision puncture in treatment of complex renal calculi. Methods From June 2015 to October 2016, 48 cases of complicated renal calculi were treated with multi-channel lithotripsy with visual standard channel ultrasonic pneumatic lithotripsy combined with visual superfine channel PCNL precision puncture holmium laser lithotripsy. Including 10 cases of staghorn stone, 38 cases of multiple renal stones. Results 110 channels were established in 48 patients. 4 cases of preoperative renal insufficiency with infection in the puncture found in the pus and stones load larger, intraoperative diarrhea and PCNL simple treatment of obstruction site stones; 44 cases to complete one of the surgery: There were single channel established in every one of 5 cases, and double channels established in every one of 24 cases, three channels in established in every one of 15 cases; There were two cases of surgery in 8 cases and there were 12 new channels established. The average time of unilateral first operation was 75 (35 ~ 125) min. The first clearance rate was 79.2% (38/48), and the total clearance rate of postoperative stone was 87.5% (42/48). 6 cases of residual stone combined with ESWL and drug row of stone, followed up for 3 months, 6 cases of stone row net, the total stone clearance rate of 100.0% (48/48). Two consecutive postoperative no sepsis, bleeding, ureteral injury and other serious complications. Conclusions Visual standard channel combined with visual superfine channel PCNL precise puncture for the treatment of complex renal calculi is safe and effective, with high fruiting rate and low complication, which can be popularized in clinical practice.
ABSTRACT
Objective To observe ransurethral flexible ureteroscopey for two-step precise method treatment of parapelvic cyst. Methods From May 2014 to November 2015, 23 patients of parapelvic cyst underwent a ransurethral flexible ureteroscopey for two-step precise method treatment, then analyze the clinical data of patients, observe the therapeutic effect. Results All patients underwent primary surgery successfully while 4 cases among them were confirmed as urine level puncture calyceal diverticulum treated with flexible ureteroscopy diverticulum expand drainage, the other 19 cases were confirmed as renal cyst and treated with cyst incision drainage successfully. The hemoglobin before and after surgery showed no changes. With no blood transfusion, the average postoperative hospitalization time was 2 d. 1 day after surgery, KUB was to locate the DJ tube position; 1 month later, ultrasound or CT check show that the cyst volume was significantly reduced, postoperative follow-up range from 6 months to 1 year. All the patients had no long-term complications. Conclusion Ransurethral flexible ureteroscopey for two-step precise method treatment of parapelvic cyst and renal pelvis lamp beside diverticulum provide a clear direction for the next operation. It's simple operation with no significant complications and recovered quickly, which is an ideal method for the treatment of renal pelvic.
ABSTRACT
Objective To observe the clinical effect of oblique supine lithotomy position rigid single-access percutaneous nephrolithotomy combined with FURS in treatment of complex urinary tract stones. Methods From May 2013 to January 2016, 40 cases of multiple kidney stones and staghorn calculi patients underwent oblique supine lithotomy position balloon establish standard single renal access, using percutaneous percutaneous combind with FURS, clinical data of patients, including operative time, blood loss, stone stone clearance rate, hospitalstay, incidence of complications and other indicators. Results The patients were successfully implemented Phase I single-access surgery, the median time 52.5 min, stone stone clearance rate of 100%, before and after surgery no difference in the amount of bleeding, no blood transfusion patients, followed up for 3 months to six months, no significant concurrent operation disease. Conclusion Oblique supine lithotomy bit single-access percutaneous percutaneous combined with FURS treatment of complex renal calculi can improve stone clearance rate, increased patient comfort during surgery to avoid damage to the kidneys multi-channel, shorter operative time, treatment obvious.
ABSTRACT
Objective To explore the feasibility and safety of visualization puncture combined with flexible ureteroscopy in the treatment of lower calyx stones.Method Visualization puncture combined with flexible ureteroscopy to treat the lower calyx stones was done in our center from January to August 2016 in our hospital.32 cases of patients were enrolled to have a retrospective analysis.There were 18 males and 14 females,aged from 25 to 65 years,with an average age of 43 years.The diameter of stone was 1.0-2.0 cm,with an average of (1.4 ± 0.6) cm.We used general anesthesia and then adjusted the surgery bed to operation side lateral elevation was 30 °-35.Flexible ureteroscopy with 200μm holmium laser was used firstly to break calculi as much as possible.Ultrasound-guided F4.8 visualization puncture system was used to establish F4.8 channel.The power option was 2001μm hohnium laser to crush calculus of the renal calculi to treat the calculus of the distal end of soft lens which still can not be touched by ureteroscopy.Routine nephrostomy tube was not placed.The soft ureter sheath F5 double-J tube,and indwelling balloon catheter were routinely placed.We removed the catheter after 1-2 days and the double J tube after 4 to 6 weeks.Results The flexible ureteroscopy lithotripsy operation time was 8-25 mins in all of the 32 patients.Visualization puncture channels were successfully established in 3-7 mins,and the visualized puncture stone search rate of 100％ (32/32).The success rate of first stage lithotripsy was 93.8％ (30/32).Two cases of lower calyx stones diverticulum diverted to PNCL due to poor visibility by bleeding.The operation time was 30-60 mins and the average of 45 mins.KUB review at day one after the surgery showed that there were residual stones in 5 cases.The stone free rate at one month after the surgery is 100.0％.The average postoperative hospital stay was (2.0 ± 1.5) days.There were uo bleeding,ureteral avulsion and perforation,septic shock,pleural effusion and intestinal injury and other serious complications.Conclusions Navigation ultrasound-guided visualization puncture combined with flexible ureteroscopy is safe and effective to treat lower calyx stones.
ABSTRACT
Objective To investigate the long-term outcome of radical prostatectomy (RP) in the patients with incidental prostate cancer (IPCa) detected by surgery of benign prostatic hyperplasia (BPH) and to evaluate the risk factors for residual tumour after BPH surgery and biochemical recurrence in patients with IPCa treated with RP.Methods We retrospectively analyzed the clinical and follow-up data of 45 patients with IPCa detected by surgery of BPH and undergoing RP from January 2004 to October 2016.The age,PSA before and after BPH surgery,prostate volume,T stage and Gleason score after the BPH surgery,T stage at RP (pT0,pT2,pT3),Gleason score at RP and status of biochemical recurrence were recorded.Multivariate logistic regression analysis addressed the association between the factors and the presence of residual cancer after the surgery for BPH.Cox regression was used to analyzed the relationship between the factors and the rate of biochemical recurrence after RP.Results Among 45 IPCa patients,21 patients were stage T1a and 24 were stage T1b.After RP,7 (15.6％) patients had no residual tumor (pT0).PSA before BPH surgery (RR =2.58,95％ CI 1.27-5.42,P =0.04),PSA after BPH surgery (RR =4.26,95％ CI 2.57-7.64,P =0.01) and Gleason score after BPH surgery (RR =3.98,95％ CI 1.85-5.77,P =0.02) were significant associated factors with the residual cancer after BPH surgery.With a mean follow-up of 54 months(ranging 5-144 months),the 5-and 10-years.biochemical recurrence-free survival rates were 95.6％ and 86.7％,respectively.PSA after surgery for BPH (RR =4.79,95％ CI 2.57-7.64,P =0.02) and Gleason score after RP(RR =2.01,95％ CI 1.74-5.21,P =0.04) were the only independent risk factors for biochemical recurrence.Stage (T1a-T1b) did not predict residual cancer or the rate of biochemical recurrence (P ＞ 0.05).Conclusions RP in the patients with IPCa detected by BPH surgery had a good outcome of long-term oncological control.PSA before and after BPH surgery and Gleason score at BPH surgery were the significant associated factors of residual cancer after BPH surgery.PSA after BPH surgery and Gleason score at RP were the only independent risk factors for biochemical recurrence.
ABSTRACT
Objective To investigate the long-term outcome of radical prostatectomy (RP) in the patients with incidental prostate cancer (IPCa) detected by surgery of benign prostatic hyperplasia (BPH) and to evaluate the risk factors for residual tumour after BPH surgery and biochemical recurrence in patients with IPCa treated with RP.Methods We retrospectively analyzed the clinical and follow-up data of 45 patients with IPCa detected by surgery of BPH and undergoing RP from January 2004 to October 2016.The age,PSA before and after BPH surgery,prostate volume,T stage and Gleason score after the BPH surgery,T stage at RP (pT0,pT2,pT3),Gleason score at RP and status of biochemical recurrence were recorded.Multivariate logistic regression analysis addressed the association between the factors and the presence of residual cancer after the surgery for BPH.Cox regression was used to analyzed the relationship between the factors and the rate of biochemical recurrence after RP.Results Among 45 IPCa patients,21 patients were stage T1a and 24 were stage T1b.After RP,7 (15.6％) patients had no residual tumor (pT0).PSA before BPH surgery (RR =2.58,95％ CI 1.27-5.42,P =0.04),PSA after BPH surgery (RR =4.26,95％ CI 2.57-7.64,P =0.01) and Gleason score after BPH surgery (RR =3.98,95％ CI 1.85-5.77,P =0.02) were significant associated factors with the residual cancer after BPH surgery.With a mean follow-up of 54 months(ranging 5-144 months),the 5-and 10-years.biochemical recurrence-free survival rates were 95.6％ and 86.7％,respectively.PSA after surgery for BPH (RR =4.79,95％ CI 2.57-7.64,P =0.02) and Gleason score after RP(RR =2.01,95％ CI 1.74-5.21,P =0.04) were the only independent risk factors for biochemical recurrence.Stage (T1a-T1b) did not predict residual cancer or the rate of biochemical recurrence (P ＞ 0.05).Conclusions RP in the patients with IPCa detected by BPH surgery had a good outcome of long-term oncological control.PSA before and after BPH surgery and Gleason score at BPH surgery were the significant associated factors of residual cancer after BPH surgery.PSA after BPH surgery and Gleason score at RP were the only independent risk factors for biochemical recurrence.
ABSTRACT
Objective To observe the clinical effect of modified laparoscopic adrenalectomy for adrenal pheochromocytoma. Methods 23 patients with adrenal pheochromocytoma were treated with modified posterior laparoscopic adrenalectomy. The changes of blood pressure, heart rate, operation time and blood loss during and after operation were observed. Results 23 patients were successfully operated, the operation time was (62.3 ± 11.7) min, the intraoperative blood loss was (34.4 ± 17.7) ml, there has no hemorrhage occurred while 3 cases were transferred to ICU for intraoperative blood pressure and heart rate fluctuation significantly, and back to general ward after 2 days, while there was no significant difference in blood pressure and heart rate preoperatively. Conclusion Modified laparoscopic adrenalectomy is safe and effective for pheochromocytoma and holds the advantages of clear anatomy, short operative time, less bleeding and less change in blood pressure and heart rate.
ABSTRACT
Objective Comparing and analyzing the advantages and disadvantages of rigid and flexible ureteroscopy in treatment of renal multiple stones or staghorn calculi. Methods 80 patients of renal multiple stones and staghorn calculi from May 2012 to March 2015 were randomly divided into two groups, group A: flexible ureteroscopy as adjuvant technique of balloon dilatation to establish standards channel of rigid nephrolithotripsy, group B: rigid ureteroscopy as auxiliary to flexible ureteroscopy nephrolithotomy. Clinical data of the two groups including operative time, blood loss, stones clearance rate, hospital stay and other indicators of surgical complications were comparatively analyzed. Results TAll the patients received successful surgical procedures. The operation time in group A was 50.4 min, gravel time was 25.6 min, while operation time in group B was 90.3 min, gravel time was 70.3 min. The differences between the two groups was statistically significant. Other indicators such as blood loss, stones clearance rate, complication rate showed no statistical significance. Conclusion Combined techniques of rigid and flexible ureteroscopy was proceeded widely to improve stone clearance rate when dealing with multiple stones and staghorn calculi, while rigid-ureterscopy-based combination has advantages of shorter operation time and this combination should be promoted in top units.
ABSTRACT
Objective To evaluate the efficacy and safety of tubeless of modular flexible ureteroscope combined with ultramini nephrostomy tract for the treatment of upper ureteral calculi in paediatric patients. Methods 20 cases of children with upper ureteral calculi (age≤7 years old), in our hospital underline of modular flexible ureteroscope combined with ultramini nephrostomy tract lithotripsy, the stones located on the left side in 12 cases, 8 cases on the right. The average age of children in the 4 years (2 to 7 years), the average diameter of stones 1.0 cm (0.7 ~1.5 cm), multiple 9 (including 3 cases of multiple bilateral, 6 cases of unilateral multiple) single stones 11 cases. Ultrasound-guided percutaneous nephrolithotomy establish supermicro channel (F11), application modular and flexible uretero﹣scope holmium laser lithotripsy systems. Results Tubeless of modular flexible ureteroscope combined with ultramini nephrostomy tract calculi Clear Phase 91%(21/23), 2 cases of bilateral stones with phased surgical treatment, surgi﹣cal staging stone clearance rate was 100 % (23/23). Postoperative hemoglobin decline was no significant change. Children do not need a blood transfusion, creatinine, blood urea nitrogen and CRP were no significant differences in change, not placed before and after surgery and renal fistula DJ tube (no tube-based). The mean postoperative hospi﹣tal stay was two days, followed up for 6 months to 1 year, all patients had no long-term complications. Conclusion Tubeless of modular flexible ureteroscope combined with ultramini nephrostomy tract for the treatment of Upper ureteral calculi in paediatric patients is an effective and safety method, can shorten hospital stay.
ABSTRACT
BACKGROUND: The hypospadias is usually repaired by the autologous tissues by surgery, but there is few local tissues available in patients with urinary leakage after I stage surgical repair, while other tissues require complex operations and induces large injury.OBJECTIVE: To observe the tissue engineered patches in the treatment of hypospadias, and to evaluate the biocompatibility and clinical efficacy.METHODS: Eight patients with urinary leakage after surgery for hypospadias repair underwent tissue patch I stage urethroplasty from January 2009 to October 2010. The curative effect and perioperative histocompatibility were determined.RESULTS AND CONCLUSION: Eight patients were uniformly successful after I stage surgery. One out of the 8 patients appeared mild urinary leakage and well cured by topical fibrin glue. There was no fever, local edema, skin tube and flap necrosis occurred during the postoperative hospital stay. All patients were followed up for 4-6 months, patients were observed to urinate standing, without urinary leakage, refractory prepuce edema and other complications.
ABSTRACT
Objective To evaluate the value of retroperitoneal laparoscopic adrenalectomy for benign adrenal tumors.Methods From March 2003 to May 2008,78 patients with adrenal tumors received retroperitoneal laparoscopic adrenalectomy in our hospital. During the operation,three trocars were introduced into the lumbar region to establish retroperitoneal space by blunt dissection with the camera. Afterwards,the tumor was removed by using a harmonic scalpel. Results The procedures were successfully completed in all the 78 cases without blood transfusion,the operation time ranged from 45 to 180 min (mean,90 min). Drainage tubes were removed 24 hours after the operation. And the patients were discharged from hospital in 3 to 5 days postoperation. One patient showed regional subcutaneous emphysema after the surgery and was cured spontaneously. The patients were followed up for 3 to 24 months with a mean of 10 months,during which 36 patients achieved normal blood pressure in 3 months,while in the other 7 patients,oral antihypertension drugs were still needed. No patients had recurrent tumor during the follow-up. Conclusions Retroperitoneal laparoscopic can be the first choice for adrenal tumors,as it is safe and effective with minimal invasion,quick recovery,and short postoperative hospital stay.