Bladder Cancer Clinical Trial
Official title:
Preliminary Report Following A Modified Uretero-Ileal Anastomosis in An Ileal Neobladder Combining Wallace Technique With an Extramural Subserous Tunnel in a Single Trough: Our Initial Short-term Results
Verified date | November 2019 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
there are many techniques for uretero-ileal anastomosis some of them are antirefluxing for
protection of the upper urinary tract with many complications including strictures and
pyelonephritis with difficult technical issues and long operation time so a modified
technique combining the 2 ureter by wallace technique and implanted them in a single trough
in the neobladder making the surgery easier and shorter.
this technique was done after informed consent in 45 patients with muscle invasive bladder
cancer candidate for radical cystectomy and ileal neobladder diversion
Status | Completed |
Enrollment | 45 |
Est. completion date | September 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
The inclusion criteria: - Patients with invasive bladder cancer (T2, T3). - good performance status - patients with serum creatinine = 2 mg/dL - prostatic urethra free of tumor. - willing to adhere to the follow up regimen. The exclusion criteria: - patients not fit for surgical intervention. - patients with renal or hepatic dysfunction. - male patients with positive urethral biopsy or diffuse CIS. - female patients with bladder neck or vaginal involvement. - concomitant pathological condition in the distal ureters necessitating the excision of a significant segment that hinders proper fashioning of uretero-ileal anastomosis. - Cases with markedly dilated ureters. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Chang DT, Lawrentschuk N. Orthotopic neobladder reconstruction. Urol Ann. 2015 Jan-Mar;7(1):1-7. doi: 10.4103/0974-7796.148553. Review. — View Citation
Elawady H, Mahmoud MA, Mostafa DM, Abdelmaksoud A, Safa MW, Elia RZ. Computed tomography virtual cystoscopy for follow-up of patients with superficial bladder tumours in comparison to conventional cystoscopy: An exploratory study. Arab J Urol. 2016 Jul 25;14(3):192-7. doi: 10.1016/j.aju.2016.06.003. eCollection 2016 Sep. — View Citation
Elfayoumy H, Abou-Elela A, Orban T, Emran A, Elghoneimy M, Morsy A. A novel antireflux technique for orthotopic ileal bladder substitutes-flat-segment technique: preliminary results. ISRN Urol. 2011;2011:431951. doi: 10.5402/2011/431951. Epub 2011 Sep 14. — View Citation
Fakhr I, Mohamed AM, Moustafa A, Al-Sherbiny M, Salama M. Neobladder long term follow-up. J Egypt Natl Canc Inst. 2013 Mar;25(1):43-9. doi: 10.1016/j.jnci.2013.01.001. Epub 2013 Feb 9. — View Citation
Hassan AA, Elgamal SA, Sabaa MA, Salem KA, Elmateet MS. Evaluation of direct versus non-refluxing technique and functional results in orthotopic Y-ileal neobladder after 12 years of follow up. Int J Urol. 2007 Apr;14(4):300-4. — View Citation
Shigemura K, Yamanaka N, Imanishi O, Yamashita M. Wallace direct versus anti-reflux Le Duc ureteroileal anastomosis: comparative analysis in modified Studer orthotopic neobladder reconstruction. Int J Urol. 2012 Jan;19(1):49-53. doi: 10.1111/j.1442-2042.2011.02870.x. Epub 2011 Oct 17. — View Citation
Taub DA, Dunn RL, Miller DC, Wei JT, Hollenbeck BK. Discharge practice patterns following cystectomy for bladder cancer: evidence for the shifting of the burden of care. J Urol. 2006 Dec;176(6 Pt 1):2612-7; discussion 2617-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the rate of vesicoureteral reflux (VUR) | the incidence of occurrence of reflux in the patients was assessed | after 6 months and after one year | |
Primary | the incidence of anastomotic stricture | the incidence of occurrence of uretero ileal stricture in the patients was recorded | after 6 months and after one year | |
Primary | the post operative changes in the mean serum creatinine level | the change in mean serum creatinine level of the patients was assessed | after 6 months and after one year | |
Secondary | the incidence of pyelonephritis | after 6 months and after one year | ||
Secondary | the incidence of urinary incontinence | after 6 months and after one year | ||
Secondary | the mean operative time of urinary diversion | the time elapsing from bowel selection till the beginning of wound closure | at the time of the operation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06034015 -
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of APL-1501 Extended Release (ER) Capsules Compared to APL-1202 Immediate Release (IR) Tablets in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04235764 -
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
|
||
Completed |
NCT02371447 -
VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04081246 -
Transurethral Modified En Bloc Resection For Large Bladder Tumours.
|
N/A | |
Recruiting |
NCT06059547 -
Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer
|
Phase 2 | |
Terminated |
NCT04779489 -
Checkpoint Inhibitor and Radiation Therapy in Bulky, Node-Positive Bladder Cancer
|
N/A | |
Not yet recruiting |
NCT04493489 -
Propranolol Adjuvant Treatment of Bladder Cancer
|
Phase 2 | |
Completed |
NCT03520231 -
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
|
Phase 2 | |
Recruiting |
NCT04537221 -
Nordic Cystectomy Study III - Transfusion
|
||
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Completed |
NCT01955408 -
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment
|
N/A | |
Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05562791 -
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer
|
Phase 1 | |
Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
Completed |
NCT02781428 -
To Detect the Sensitivity of the UroMark Assay
|
||
Recruiting |
NCT04738630 -
Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
|
Phase 2 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
Active, not recruiting |
NCT03978624 -
Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer
|
Phase 2 | |
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A |