Significado do uso da prótese peniana de silicone no seguimento da braquiterapia pélvica / Significado do uso da prótese peniana de silicone no seguimento da braquiterapia pélvica / Meaning of the use of silicone penile prosthesis in the follow-up of pelvic brachytherapy

Objetivo: descrever o significado do uso da prótese peniana de silicone para dilatação vaginal no seguimento da braquiterapia em mulheres com câncer ginecológico. Método: pesquisa narrativa, realizada no Centro de Pesquisas Oncológicas, Brasil, com 34 mulheres, após braquiterapia pélvica, em seguimento no serviço de fisioterapia. Coleta de dados por entrevistas semiestruturadas, incluindo dados sociodemográficos, clínicos e o significado do uso da prótese peniana na dilatação vaginal, submetidas à análise de conteúdo e discutidas à luz do estudo From 'sex toy' to intrusive imposition. Resultados: o significado perpassa o exercício de dilatação vaginal; as dificuldades relacionadas às condições vaginais, doença, tratamento, dor, sexo, constrangimentos, preconceitos, falhas na educação em saúde; as motivações relacionam-se à busca por qualidade de vida, apoio dos companheiros e profissionais. Conclusão: a abordagem de possíveis barreiras emocionais, psicológicas, sociais e físicas deve ser planejada e executada para prevenção da estenose vaginal e melhor acolhimento.

Objective: to describe the meaning of the use of silicone penile prosthesis for vaginal dilation in the follow-up of brachytherapy in women with gynecological cancer. Method: narrative research conducted at the Centro de Pesquisas Oncológicas, Brazil, with 34 women after pelvic brachytherapy, under follow-up at the physical therapy service. Data collection through semi-structured interviews, including sociodemographic and clinical data and the significance of the use of penile prosthesis in vaginal dilation, submitted to content analysis and discussed in the light of the study From 'sex toy' to intrusive imposition. Results: the meaning permeates the vaginal dilation exercise; difficulties related to vaginal conditions, disease, treatment, pain, sex, constraints, prejudices, failures in health education; motivations are related to the search for quality of life, support of partners and professionals. Conclusion: the approach of possible emotional, psychological, social and physical barriers should be planned and executed for prevention of vaginal stenosis and better reception.

Objetivo: describir el significado del uso de una prótesis peneana de silicona para la dilatación vaginal posterior a la braquiterapia en mujeres con cáncer ginecológico. Método: investigación narrativa, realizada en el Centro de Pesquisas Oncológicas, Brasil, con 34 mujeres, después de braquiterapia pélvica, en seguimiento en el servicio de fisioterapia. Recopilación de datos a través de entrevistas semiestructuradas, incluyendo datos sociodemográficos y clínicos y el significado del uso de prótesis peneana en la dilatación vaginal, sometidos a análisis de contenido y discutidos a la luz del estudio From 'sex toy' to intrusive imposition. Resultados: el significado impregna el ejercicio de dilatación vaginal; dificultades relacionadas con condiciones vaginales, enfermedad, tratamiento, dolor, sexo, vergüenza, prejuicios, fallas en la educación para la salud; las motivaciones están relacionadas con la búsqueda de calidad de vida, apoyo de la pareja y profesionales. Conclusión: se debe planificar y ejecutar el abordaje de las posibles barreras emocionales, psicológicas, sociales y físicas para prevenir la estenosis vaginal y una mejor recepción.

Nasal dilator and physiological parameters associated to running performance: A systematic review and meta-analysis.

Nasal dilators were created to expand the nasal valve area. The aim of this systematic review was to verify physiological parameters associated to running performance with the use of nasal dilators. This study was registered in PROSPERO (CRD42021225795). According to the PICOS framework studies were included: Population: healthy subjects; Intervention: nasal dilators; Comparison: control group, placebo, minimal intervention, health education or other intervention; Outcomes: cardiorespiratory parameters and subjective perceptions; Study: randomized controlled trials, repeated measures or within-subjects design. The databases searched were MEDLINE, EMBASE, CENTRAL The Cochrane Library, CINAHL, SPORTDiscus, Web of Science, PEDro and Scopus. The descriptors "Running", "Nasal Dilator", "Randomized Controlled Trial", and synonyms were used. The risk of bias was assessed using the PEDro scale. Random effects Der Simonian and Laird model were used. The assessment of the certainty of the evidence was carried out using the GRADE approach. Eleven articles were included. There was a difference in favour of the nasal dilator when compared to placebo for maximal oxygen uptake and rating of perceived exertion. The certainty of the evidence was very low. Future studies will probably have an impact on estimation of the effect.

Analysis of long-term effect of ureteral balloon dilatation combined with internal and external drainage tube in the treatment of benign ureteral stricture.

PURPOSE: There are few reports about balloon dilatation combined with internal and external drainage tube in the treatment of ureteral stricture under interventional therapy. The aim of the study is to explore the safety, effectiveness and long-term efficacy of this treatment strategy. MATERIALS AND METHODS: It is a retrospective and observational study. From October 2013 to October 2016, 42 patients with benign lower ureteral stricture received interventional treatment. Balloon dilatation combined with internal and external drainage tube implantation were used. There were 25 male patients and 17 female patients. There were 7 cases (16.7%) with congenital ureteral stricture, 12 cases (28.6%) with inflammation, 15 cases (35.7%) with ureteral stricture after lithotomy or lithotripsy, and 8 cases (19.0%) with ureteral stricture after pelvic or abdominal surgery. After the drainage tube was removed, B ultrasound, enhanced CTU or IVP of urinary system were reexamined every six months. The follow-up time was 12-60 months. RESULTS: The age was 52.9 ± 11.6 years. The length of ureteral stricture was 1.1 ± 0.5 cm. 42 patients completed interventional treatment, the technical success rate was 100%, no ureteral perforation, rupture or other complications were identified. Preoperative urea nitrogen 9.2 ± 2.3 mmol/L and creatinine 175.8 ± 82.8umol/L. Urea nitrogen and creatinine were 3.8-9.1 mmol/L and 45.2-189.6 umol/L when removing the drainage tube. There were significant differences in the levels of urea nitrogen and creatinine before and after tube removal (P < 0.05). The ureteral patency rate was 100% at 6 months, 93% at 12 months, 83% at 18 months, 79% at 24 months, 76% at 30 months and 73% at 36-60 months. The overall success rate was 73%. Multivariate Cox regression analysis showed that stenosis length was a risk factor for postoperative patency (P < 0.05). CONCLUSION: Balloon dilatation combined with internal and external drainage tube implantation in the treatment of benign lower ureteral stricture is safe and effective.

One-Shot Dilatation vs Metal Dilator During Percutaneous Nephrolithotomy in Flank-Free Supine Position: A Randomized Controlled Study.

Background: The creation and dilatation of the nephrostomy tract is a fundamental step in percutaneous nephrolithotomy (PCNL). In one-shot dilatation (OSD), we used a single Amplatz dilator over a central Alken rod. PCNL in the supine position is as effective and safe as in the prone position. The Barts flank-free modified supine position sums several advantages of the different supine positions. We evaluated the efficacy and safety of OSD compared with metal telescopic dilator (MTD) during PCNL while the patient was in Barts flank-free modified supine position. Materials and Methods: Within 2.5 years, 150 patients with kidney stone candidates for PCNL were randomized into two equal groups according to the dilatation technique. In the OSD group, dilatation was performed using a single Amplatz dilator (30F) and in the MTD group dilatation was performed by sequential MTD (9-30F). All PCNL procedures were done with patients in Barts flank-free modified supine position. Patient characteristics, operative data, and results were collected for statistical analysis. Results: There are no statistically significant differences between both groups regarding patients' characters. The tracts were effectively dilated in all patients. Statistical analyses show a significant difference (p ˂ 0.05) between both groups regarding the time of dilatation (seconds; 68 ± 15 vs 147 ± 18), time of X-ray exposure (seconds; during dilatation; 36 ± 10 vs 61 ± 15 and the total; 157 ± 16 vs 181 ± 20), hemoglobin loss (mg/dL; 0.7 ± 0.2 vs 1.2 ± 0.3), and hospital stay (days; 3 ± 0.6 vs 3.7 ± 0.7) with favorable results to OSD. Complication rates were comparable between the two groups. Conclusions: OSD is efficient as MTD during PCNL while patients are in Barts flank-free modified supine position, with less dilatation time, X-ray exposure, blood loss, and hospital stay than MTD.

New Technologies for Treatment of Benign Prostatic Hyperplasia.

BPH is a common disease in aging men which impacts quality of life. With advancing age expectation coupled with the rising demand for BPH therapy, new technologies have been developed that target rapid recovery and symptom relief, low complication rates, and the ability to perform the procedure in an outpatient setting with local anesthesia. MIST technologies have fostered BPH medical care with ejaculation preservation. Techniques and outcomes for BPH technologies including Aquablation, Rezum, UroLift, iTind, Optilume BPH, XFLO, Zenflow, and Butterfly are reviewed and evaluated. Given the novelty of these technologies, long-term data are required to assess safety and efficacy.

Design and Validation of an Automated Dilator Prototype for the Treatment of Radiation Induced Vaginal Injury.

Vaginal stenosis (VS) is a common late complication of radiation injury caused by cervical cancer radiotherapy. It is characterized by the narrowing or shortening of the vaginal canal, which is often detrimental to patient quality of life. To address this public health problem, an expandable vaginal dilator was designed for the prevention of VS in cervical cancer survivors. Modeling and benchtop experimentation were used to iteratively characterize the relationship among dilator pressure, expansion, and the load applied to the simulated vaginal wall. Both experimental and simulation results exhibited shared trends relating pressure, dilator expansion, applied load, and resultant displacement of the modeled vaginal walls. Future work will incorporate enhanced Mooney-Rivlin material assumptions and validation of the model with in vivo tests.Clinical Relevance- These results present a design opportunity and treatment paradigm shift to increase patient adherence to VS treatment after cervical cancer radiotherapy. Specifically, gradual expansion of the vaginal dilator increases comfort during the expansion of the vagina, while monitoring the dilator pressure enables the tracking of VS improvement and normalization of vaginal wall compliance.

Ex Vivo Model of Ischemic Mitral Regurgitation and Analysis of Adjunctive Papillary Muscle Repair.

Ischemic mitral regurgitation (IMR) is particularly challenging to repair with lasting durability due to the complex valvular and subvalvular pathologies resulting from left ventricular dysfunction. Ex vivo simulation is uniquely suited to quantitatively analyze the repair biomechanics, but advancements are needed to model the nuanced IMR disease state. Here we present a novel IMR model featuring a dilation device with precise dilatation control that preserves annular elasticity to enable accurate ex vivo analysis of surgical repair. Coupled with augmented papillary muscle head positioning, the enhanced heart simulator system successfully modeled IMR pre- and post-surgical intervention and enabled the analysis of adjunctive subvalvular papillary muscle repair to alleviate regurgitation recurrence. The model resulted in an increase in regurgitant fraction: 11.6 ± 1.7% to 36.1 ± 4.4% (p < 0.001). Adjunctive papillary muscle head fusion was analyzed relative to a simple restrictive ring annuloplasty repair and, while both repairs successfully eliminated regurgitation initially, the addition of the adjunctive subvalvular repair reduced regurgitation recurrence: 30.4 ± 5.7% vs. 12.5 ± 2.6% (p = 0.002). Ultimately, this system demonstrates the success of adjunctive papillary muscle head fusion in repairing IMR as well as provides a platform to optimize surgical techniques for increased repair durability.

[Radiation-induced sexual toxicity]. / Toxicité sexuelle induite par la radiothérapie.

Oncosexuality has recently become a new supportive care mission. Sexual morbidity is, routinely, underestimated and must be questioned. We report here the most frequent disorders for men and for women, how to prevent them and how to treat them.

Ephemeral history of the three-bladed tracheostomy dilator.

Tracheostomy remains a topical surgical procedure. The history of tracheostomy is marked by the development of various instruments, including the three-bladed tracheostomy dilator from the middle of the 19th century. The purpose of this historical note is to recall the use of this unusual instrument.

Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial.

BACKGROUND: We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. METHODS: open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18-75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. RESULTS: the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37). CONCLUSIONS: there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials, RBR-23w5fv . Registered 10 January 2017 - Retrospectively registered.

The Innovative Use of Ureter Catheter in the Surgery of Obstructive Uropathy.

PURPOSE: Relieving obstruction and protecting renal function are the main therapeutic purposes of obstructive uropathy which often involve surgical treatment, and the ureter catheter is one of the surgical instruments commonly used in surgery. We aimed to explore the innovative use of a ureter catheter in the surgery of obstructive uropathy. METHODS: We used a ureteral catheter to innovate the surgical procedure of the most common causes of obstructive uropathy: ureteral calculi and stricture, establishing an internal circulation system (ICS), proposing a three-step dilatation method, and reviewing their effects on patients. Furthermore, we introduced a simple real-time intrapelvic pressure measurement device to monitor intrarenal pressure during operation. RESULTS: Postoperative laboratory examination showed that blood CRP, leukocyte neutrophil level, changes in the hemoglobin, urine occult blood, and positive rate of urine culture in the ICS group are significantly lower than those in the control group, corresponding to a lower incidence of bleeding and infection-related complications clinically. A three-month follow-up revealed 1/3 rate of ureteral stricture in the ICS group comparing to the control. We applied the three-step dilatation in patients with severe stenosis in which the balloon could not pass; the overall effective rate was 90.9%. The pressure of the renal pelvis was displayed on the monitor in real time. The surgeon could estimate the degree of filling of the renal pelvis and adjust the intake volume through the data. CONCLUSION: The innovative application of ureteral catheters in the operation of obstructive uropathy can realize the real-time monitor of intraoperative renal pelvis pressure, reduce the incidence of lithotripsy postoperative complications, and expand the indications of balloon dilatation in ureteral stricture, which has certain clinical significance.

Efficacy and safety of modified tract dilation technique using simultaneous pulling of proximal and distal ends of a guidewire for percutaneous nephrolithotomy in modified supine position.

PURPOSE: Recently, the needs for supine percutaneous nephrolithotomy (PCNL) have become more increased because of an easy approach for endoscopic combined intrarenal surgery. However, making a nephrostomy tract during supine PCNL is more difficult than prone position due to movable kidney. To overcome this limitation, we used a modified nephrostomy tract dilation (MTD) technique using guidewire traction. MATERIALS AND METHODS: From January 2014 to June 2019, a total of 259 patients underwent PCNL in the modified supine position. Among them, the MTD technique was performed in 171 patients. For the MTD technique, two hydrophilic guidewires were passed from the nephrostomy tract and brought out through the urethra, then both proximal and distal ends were contralaterally pulled with tension for the easy placement of a fascia-cutting needle and a balloon catheter. We analyzed the efficacy of this technique in comparison with the conventional method. RESULTS: Intraoperative radiation exposure time (RET) (68.87 vs. 212.11 s) and hospital stay (5.90 vs. 6.74 days) were significantly shorter, while the success rate (77.2% vs. 63.6%) was significantly higher in the MTD group. Multivariate analysis showed that only the maximal stone diameter (odds ratio [OR], 1.928; 95% confidence interval [CI], 1.314-2.828; p=0.001) and MTD technique (OR, 0.017; 95% CI, 0.007-0.040; p<0.001) were independent factors for predicting short RET (<120 s). CONCLUSIONS: This study demonstrated that MTD technique can be effectively and safely performed in modified supine position PCNL, and it can be helpful in reducing RET and enhancing success rates.

Determining the Safety Threshold for the Passage of a Ureteral Access Sheath in Clinical Practice Using a Purpose-Built Force Sensor.

PURPOSE: Ureteral injury is a frequent complication of ureteral access sheath deployment. We sought to define the safe threshold of force for the passage of a ureteral access sheath using a novel ureteral access sheath force sensor. MATERIALS AND METHODS: Ureteral access sheath-force sensor measurements were recorded in 210 renal units. A 16Fr ureteral access sheath was deployed initially based on a prior porcine study. If 6 N was reached, the surgeon was advised to downsize the 16Fr ureteral access sheath. In each case, a post-ureteroscopic lesion scale was recorded. Regression models were used to estimate the impact of adjusted variables on post-ureteroscopic lesion scale grade, 16Fr ureteral access sheath deployment, and peak force. RESULTS: A 16Fr ureteral access sheath was deployed in 127 (61%) renal units with a mean peak force of 5.7 N. Two high-grade ureteral injuries occurred; in both cases >6 N of force was recorded. Post-ureteroscopic lesion scale grade correlated directly with peak insertion force (p <0.01). Bacteriuria within 60 days of the procedure (OR 2.009, p=0.034), combination of preoperative stent plus oral tamsulosin (OR 2.998, p=0.045), and prior ipsilateral stone surgery (OR 2.13, p=0.01) were independent predictors of successful 16Fr ureteral access sheath deployment. Among patients with neither prior ipsilateral stone surgery nor preoperative stent, preoperative tamsulosin facilitated passage of a 16Fr ureteral access sheath (OR 2.750, p=0.034). CONCLUSIONS: Ureteral access sheath associated ureteral injury can be averted by limiting the insertion force to ≤6 N. Prior stone surgery, preoperative indwelling ureteral stent plus oral tamsulosin, and recently treated bacteriuria favored passage of a 16Fr ureteral access sheath. In the naïve, unstented patient, preoperative tamsulosin favored deployment of a 16Fr ureteral access sheath.

Developmental Anatomy of the Eustachian Tube: Implications for Balloon Dilation.

OBJECTIVE: To describe the developmental anatomy of the eustachian tube (ET) and its relationship to surrounding structures on computed tomography. STUDY DESIGN: Case series with chart review. SETTING: A tertiary care hospital. METHODS: ET anatomy was assessed with reformatted high-resolution computed tomography scans from 2010 to 2018. Scans (n = 78) were randomly selected from the following age groups: <4, 5 to 7, 8 to 18, and >18 years. The following were measured and compared between groups: ET length, angles, and relationship between its bony cartilaginous junction and the internal carotid artery and between its nasopharyngeal opening and the nasal floor. RESULTS: The distance between the bony cartilaginous junction and internal carotid artery decreased with age between the <4-year-olds (2.4 ± 0.6 mm) and the 5- to 7-year-olds (2.0 ± 0.3 mm, P = .001). The ET length increased among the <4-year-olds (32 mm), 5- to 7-year-olds (36 mm), and 8- to 18-year-olds (41 mm, P < .0001). The cartilaginous ET increased among the <4-year-olds (20 mm), 5- to 7-year-olds (25 mm), and 8- to 18-year-olds (28 mm, P < .0001). The ET horizontal angle increased among the <4-year-olds (17°), 5- to 7-year-olds (21°), and 8- to 18-year-olds (23°, P≤ .003), but the ET sagittal angle did not statistically change after 5 years of age. The height difference between the nasopharyngeal opening of the ET and the nasal floor increased among the <4-year-olds (4 mm), 5- to 7-year-olds (7 mm), and 8- to 18-year-olds (11 mm, P < .0001). CONCLUSION: The ET elongates with age, and its angles and relationship to the nasal floor increase. Although some parameters mature faster, more than half of the ET growth occurs by 8 years of age, and adult morphology is achieved by early adolescence.

Safety of percutaneous dilatational tracheotomy (PDT) with the rigid tracheotomy endoscope (TED): a 6-month follow-up multicenter investigation.

BACKGROUND: The rigid tracheotomy endoscope (TED) was recently introduced to improve the fiberoptic technique during percutaneous dilatational tracheotomy (PDT) in critically ill patients. The aim was to evaluate the long-term complications of PDT using TED equipment in a prospective multicenter investigation. METHODS: One hundred eighty adult patients underwent PDT using TED in four German hospitals. Patients who were alive or their guardians were contacted via telephone and interviewed using a structured questionnaire 6 months following the tracheostomy procedure. Patients with airway complaints were invited for outpatient clinical ENT examination. The incidence of adverse events related to PDT was registered. RESULTS: Of 180 patients who received tracheostomy, 137 (76.1%) were alive at the time of follow-up. None of the 43 lethal events was related to the PDT. Fifty-three (38.7%) patients were available for follow-up examination, whereas 14 (10.2%) were able to visit ENT physicians. Two (3.8%) out of 53 patients developed tracheocutaneous fistula with required surgical closure of tracheostoma. Dyspnea (7.5%), hoarseness (5.7%), stridor and swallowing difficulties (both with 3.8%) were the most common complaints. Tracheal stenosis was confirmed in 1 patient (1.88% [95% CI: 0.33; 9.93]). CONCLUSION: The use of TED for PDT in the clinical setting is safe regarding adverse events at 6-month follow-up. The incidence of tracheal stenosis after PDT with TED is comparable with that of flexible bronchoscopy; however, its role for PDT at the intensive care unit should be clarified in further investigations.

Can ultrasound guidance reduce radiation exposure significantly in percutaneous nephrolithotomy in pediatric patients?

In this study, we aimed to compare clinical and technical outcomes between pediatric patients who underwent percutaneous nephrolithotomy (PCNL) under fluoroscopy (FL) and those that underwent this procedure under FL with ultrasound assistance (FLUSA). The data of 66 PCNL patients were analyzed retrospectively. Renal puncture was successful in 22 patients in the FLUSA group and 44 patients in the FL group. In all cases, FL was used for tract dilation and confirmation of ureteral catheter positioning at the beginning of the procedure. The sample consisted of 46 males and 20 females with a mean age of 7.2 ± 2.1 years (range 1-17 years). Stone size varied from 8.0 to 75.4 mm, and 89% of patients achieved a completely stone-free state. The median puncture time was 130.5 ± 25.3 s for FLUSA and 295 ± 82.8 s for FL, the median fluoroscopic screening time was 95 ± 33 and 230 ± 116 s, respectively, and the median radiation dose was 19.04 ± 9.9 dGy/cm2 and 54 ± 21.4 dGy/cm2, respectively. The median puncture time, fluoroscopic screening time, and radiation dose were statistically lower in the FLUSA group (p = 0.001, Mann-Whitney U test). The greatest problem in PCNL is the use of fluoroscopy. Due to some anatomical differences from adults, applying PCNL in pediatric patients using only ultrasound may decrease the success rate. Puncture with ultrasound significantly reduces the radiation dose in children. Puncture with ultrasound and dilation under fluoroscopy is a successful and safe treatment method with low morbidity and high success rates and shorter hospital stay in pediatric patients.

Endoscopic Biliary Large Balloon Dilation Lithotripsy for Giant and Impacted Stones Removal: A Western Series.

BACKGROUND: Endoscopic removal of packed, large, or impacted stones, in which a basket cannot be deployed or is unable to grasp the stone(s), is challenging and inevitably leads to repeated procedures such as stent insertion and extra- or intracorporal lithotripsy. In this study, we describe the results of an alternative stone disintegration technique in a considerable series of patients using an esophageal/pyloric balloon for stone fragmentation or making working space in the bile duct to allow the deployment of the basket, a technique we call endoscopic biliary large balloon lithotripsy. METHODS: We retrieved data from 1,429 endoscopic retrograde cholangiopancreatographies (ERCPs) from 2 prospective trials performed between 2014 and 2019. Patients with difficult bile duct stones, in which a balloon dilator up to 15 mm was used to crush or increase the working space parallel to the stones in the common or hepatic duct, were included in the study. RESULTS: From the 1,429 ERCPs, 299 had difficult stones (>1 cm, impacted or multiple stones). Large balloon lithotripsy was employed in 46 cases after endoscopic papillotomy and endoscopic biliary large balloon dilation with failed attempted balloon or basket stone(s) extraction. Failure to clear the bile duct at first ERCP occurred in 4 cases (91.3% of success). Complications were observed in 5 patients (10.8%; 1 perforation, 1 pancreatitis, and 3 bleedings), who were treated conservatively. CONCLUSIONS: Large balloon lithotripsy, in order to crush the stones or make working room for baskets or balloons in the bile duct, is an effective, safe, and low cost technique for impacted, packed, or giant bile duct stones.