EUS-guided trans-esophageal drainage of a mediastinal necrotic fluid collection using the axios electrocautery enhanced delivery system™.

Mediastinal collection secondary to necrotic acute pancreatitis, is an extremely rare event caused by the posterior rupture of the pancreatic duct into the retroperitoneal space with the penetration of the pancreatic fluid through the diaphragmatic orifices. Infection of the necrotic collection may occur with a consequent substantial increase of the mortality rate. Due to the rarity of this severe condition, no consensus is known about the management of infected mediastinal necrotic collections. We reported the case of a 61-year-old male who was critically unwell secondary to a large mediastinal necrotic collections after necrotic acute pancreatitis with no improvement after surgery. The patient was successfully treated by EUS-guided trans-esophageal drainage using the AXIOS Electrocautery Enhanced Delivery System™. This procedure proved in this case to be a safe and effective option for the management of infected necrotic mediastinal collections.

Feasibility of EUS-guided Nd:YAG laser ablation of unresectable pancreatic adenocarcinoma.

BACKGROUND AND AIMS: EUS has become an interventional technique in which a needle may be used as a vehicle to deliver therapeutic agents. Laser ablation (LA) has been used to treat many primary and secondary neoplasms. This study aimed to assess the feasibility of EUS-guided LA for unresectable (UR) pancreatic cancer. METHODS: Patients with stage IIb-III pancreatic cancer underwent EUS-guided LA. All patients were unresponsive to previous chemoradiotherapy. LA was performed by using a 300-µm flexible fiber preloaded onto a 22-gauge fine needle. A 1064-nm wavelength neodymium-yttrium aluminum garnet (Nd:YAG) laser light with different power settings of 2 W for 800 J, 1000 J, and 1200 J; 3 W for 800 J, 1000 J, and 1200 J; and 4 W for 800 J, 1000 J, and 1200 J was used. Each patient was treated with a single application of 1 of these settings. The application time of the power settings ranged from 200 to 600 seconds. RESULTS: Nine patients (median age, 74.7; range 55-85) underwent Nd:Yag LA. The mean size of the focal lesion was 35.4 mm (range, 21-45). The ablation area, demonstrated by 24-hour CT, ranged from .4 cm3 (for the lower power setting of 2 W/800 J) to a maximum of 6.4 cm3 (for 4 W/1000 J). The procedure was completed in all 9 patients without adverse events. CONCLUSION: In our human experience, EUS-guided LA was feasible and well tolerated in patients with UR pancreatic cancer.

Temporary FC-SEMS for type II ERCP-related perforations: a case series from two referral centers and review of the literature.

BACKGROUND AND AIM: Some case reports have shown that fully covered self-expandable metal stents (FC-SEMS) are effective in cases of Stapfer Type II perforation as rescue treatment. The aim of the study was to assess the efficacy and safety of temporary placement of FC-SEMS as primary treatment for Type II perforations and review the literature regarding the use of FC-SEMS in this setting. PATIENTS AND METHOD: Retrospective analysis of consecutive patients with Type II perforation treated with immediate placement of FC-SEMS. Primary outcomes were need for surgery and mortality rate. Secondary outcomes were complications, technical and clinical success, time to post-operative feeding, length of the hospitalization and time to stent removal. RESULTS: Overall, 18 consecutive patients were enrolled (median age 71.5). All patients were treated with FC-SEMS (6-10 mm, 4-8 cm long). In all patients, there were no need for surgery, and no patient died. Technical and clinical success were achieved both in 100% of cases. The median time to stent removal was 43 (2-105) days. The median hospital stay was of 10 (4-21) days. Median time to post-operative feeding was 4 days (2-15). CONCLUSION: FC-SEMS placement could be a safe and effective treatment in Type II perforations and represent a valuable development and innovation of conservative treatment.

Cumulative Mass and NIOSH Variable Lifting Index Method for Risk Assessment: Possible Relations.

Objective The aim of this study was to explore whether the Variable Lifting Index (VLI) can be corrected for cumulative mass and thus test its efficacy in predicting the risk of low-back pain (LBP). Background A validation study of the VLI method was published in this journal reporting promising results. Although several studies highlighted a positive correlation between cumulative load and LBP, cumulative mass has never been considered in any of the studies investigating the relationship between manual material handling and LBP. Method Both VLI and cumulative mass were calculated for 2,374 exposed subjects using a systematic approach. Due to high variability of cumulative mass values, a stratification within VLI categories was employed. Dummy variables (1-4) were assigned to each class and used as a multiplier factor for the VLI, resulting in a new index (VLI_CMM). Data on LBP were collected by occupational physicians at the study sites. Logistic regression was used to estimate the risk of acute LBP within levels of risk exposure when compared with a control group formed by 1,028 unexposed subjects. Results Data showed greatly variable values of cumulative mass across all VLI classes. The potential effect of cumulative mass on damage emerged as not significant ( p value = .6526). Conclusion When comparing VLI_CMM with raw VLI, the former failed to prove itself as a better predictor of LBP risk. Application To recognize cumulative mass as a modifier, especially for lumbar degenerative spine diseases, authors of future studies should investigate potential association between the VLI and other damage variables.

Endoluminal Nd:YAG laser application in ex vivo biliary porcine tissue.

Adequate biliary drainage with endoscopic or percutaneous placement of self-expandable metal stents represents the goal of palliation in patients with inoperable malignant obstruction of the biliary tree. As an adjunct to stenting, various tissue ablation treatments have been proposed with conflicting results. The aim of this study was to test the effect on biliary tissue of a new ablation technique based on Nd:YAG laser light delivery. The study was conducted on ex vivo specimens of 18 healthy farm pigs, using cystic ducts that are the simplest biliary structures to isolate and cannulate ex vivo. A 22G cannula was positioned into the cystic duct and a quartz optical fibre, with a prototypal cooling system, was inserted into the cannula. Nd:YAG laser output powers of 10, 12, and 15 W were tested, with a total delivered energy of 1000 J in continuous mode in each case. After laser treatment, histological analysis was performed. At macroscopical examination, no lesions of the external wall of the cystic ducts were detected. At histopathological examination, a coagulative necrosis involving the entire mucosa up to the muscolaris propria without significant changes of periductal tissues was observed in all specimens. This study shows the possibility of using Nd:YAG laser on ex vivo porcine biliary ducts with the effect of obtaining a coagulative necrosis involving the whole mucosa.

Variable Lifting Index for Manual-Lifting Risk Assessment: A Preliminary Validation Study.

OBJECTIVE: The aim of this study was to evaluate the efficacy of the new Variable Lifting Index (VLI) method, theoretically based on the Revised National Institute for Occupational Safety and Health [NIOSH] Lifting Equation (RNLE), in predicting the risk of acute low-back pain (LBP) in the past 12 months. BACKGROUND: A new risk variable termed the VLI for assessing variable manual lifting has been developed, but there has been no epidemiological study that evaluates the relationship between the VLI and LBP. METHOD: A sample of 3,402 study participants from 16 companies in different industrial sectors was analyzed. Of the participants, 2,374 were in the risk exposure group involving manual materials handling (MMH), and 1,028 were in the control group without MMH. The VLI was calculated for each participant in the exposure group using a systematic approach. LBP information was collected by occupational physicians at the study sites. The risk of acute LBP was estimated by calculating the odds ratio (OR) between levels of the risk exposure and the control group using a logistic regression analysis. Both crude and adjusted ORs for body mass index, gender, and age were analyzed. RESULTS: Both crude and adjusted ORs showed a dose-response relationship. As the levels of VLI increased, the risk of LBP increased. This risk relationship existed when VLI was greater than 1. CONCLUSION: The VLI method can be used to assess the risk of acute LBP, although further studies are needed to confirm the outcome and to define better VLI categories.

US-guided application of Nd:YAG laser in porcine pancreatic tissue: an ex vivo study and numerical simulation.

BACKGROUND: Laser ablation (LA) with a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser is a minimally invasive approach able to achieve a high rate of complete tissue necrosis. In a previous study we described the feasibility of EUS-guided Nd:YAG pancreas LA performed in vivo in a porcine model. OBJECTIVE: To establish the best laser setting of Nd:YAG lasers for pancreatic tissue ablation. A secondary aim was to investigate the prediction capability of a mathematical model on ablation volume. DESIGN: Ex vivo animal study. SETTING: Hospital animal laboratory. SUBJECTS: Explanted pancreatic glands from 60 healthy farm pigs. INTERVENTION: Laser output powers (OP) of 1.5, 3, 6, 10, 15, and 20 W were supplied. Ten trials for each OP were performed under US guidance on ex vivo healthy porcine pancreatic tissue. MAIN OUTCOME MEASUREMENTS: Ablation volume (Va) and central carbonization volume (Vc) were measured on histologic specimens as the sum of the lesion areas multiplied by the thickness of each slide. The theoretical model of the laser-tissue interaction was based on the Pennes equation. RESULTS: A circumscribed ablation zone was observed in all histologic specimens. Va values grow with the increase of the OP up to 10 W and reach a plateau between 10 and 20 W. The trend of Vc values rises constantly until 20 W. The theoretical model shows a good agreement with experimental Va and Vc for OP between 1.5 and 10 W. LIMITATIONS: Ex vivo study. CONCLUSION: Volumes recorded suggest that the best laser OP could be the lowest one to obtain similar Va with smaller Vc in order to avoid the risk of thermal injury to the surrounding tissue. The good agreement between the two models demonstrates the prediction capability of the theoretical model on laser-induced ablation volume in an ex vivo animal model and supports its potential use for estimating the ablation size at different laser OPs.

Endotherapy of postoperative biliary strictures with multiple stents: results after more than 10 years of follow-up.

BACKGROUND: Endoscopic dilation of postoperative biliary strictures with increasing numbers of stents was first described by our group in 2001 with promising results after a long-term follow-up (mean 4 years). OBJECTIVE: To verify results of endoscopic treatment of postoperative biliary strictures at a very-long-term follow-up. DESIGN: Single center, follow-up study. SETTING: Tertiary-care, academic referral center. PATIENTS: A group of 42 patients from our 2001 study, who had undergone endoscopic dilation of postoperative biliary strictures with the multiple endoscopic stenting technique, underwent systematic follow-up. The last telephone follow-up was done in September 2009. INTERVENTION: Clinical conditions and the occurrence of new biliary symptoms during the follow-up period were assessed, and results of the most recent liver function tests and abdominal US were recovered. MAIN OUTCOME MEASUREMENTS: Occurrence of cholangitis and liver function test evaluation during the follow-up period. RESULTS: Of the 40 patients who were alive at the end of the study published in 2001, 5 (12.5%) died of unrelated causes after a mean of 6.7 years (range 3-13.3 years) from the end of treatment, without further biliary symptoms. The overall mean follow-up time for the remaining 35 patients (87.5%) was 13.7 years (range 11.7-19.8 years). Seven patients (20%) experienced recurrent acute cholangitis after a mean of 6.8 years (range 3.1-11.7 years) from the end of treatment. All 7 of these patients underwent ERCP. Four of the 7 patients had postoperative biliary stricture recurrence (n = 4/35, 11.4%) that was retreated endoscopically with placement of stents, and the other 3 patients had common bile duct stones (n = 3/35, 8.6%) that were extracted. No stricture or bile duct stone recurrences after retreatment were recorded after a mean follow-up period of a further 7.1 years (range 2.5-12.1 years). Twenty-eight patients remained asymptomatic with normal liver function test results and abdominal US results after a mean follow-up period of 13.7 years (range 11.7-19.8 years). LIMITATIONS: Telephone follow-up. CONCLUSION: Results of multiple endoscopic stenting for postoperative biliary strictures remain excellent even after a very-long-term follow-up. The stricture recurrence rate is low, and recurrences can be retreated endoscopically.

EUS-guided Nd:YAG laser ablation of normal pancreatic tissue: a pilot study in a pig model.

BACKGROUND: Laser ablation with a neodymium:yttrium aluminum garnet (Nd:YAG) laser can achieve a high rate of complete tissue necrosis and has been applied as a minimally invasive, palliative option in hepatocellular carcinoma, liver metastasis in colorectal cancer, and malignant thyroid nodules. OBJECTIVE: To assess the in vivo feasibility of EUS-guided laser ablation with an Nd:YAG laser of normal pancreatic tissue of a porcine model. DESIGN: Prospective investigation. SETTING: Hospital animal laboratory. SUBJECTS: Eight pigs. INTERVENTIONS: EUS-guided puncture of the pancreatic tail with a laser-beam fiber. An Nd:YAG laser (1.064 nm) was used, with an output power of 2 and 3 W and a total delivered energy of 500 and 1000 J in continuous mode. MAIN OUTCOME MEASUREMENTS: The 24-hour follow-up of the pigs was focused on clinical and laboratory aspects. Results of histological studies of the pancreas were obtained 24 hours after the procedure on necroscopy tissue. RESULTS: There were no technical limitations to the performance of the procedure. Tissue necrosis, localized in the pancreatic parenchyma, was observed in all animals on histological examination. The volume of ablation tissue ranged from a mean of 314 mm(3) to 483 mm(3). The ablation area ranged from a mean of 49 mm(2) to 80 mm(2). No major postprocedure complications were recorded, and all the pigs survived at 24 hours. LIMITATION: Animal study. CONCLUSIONS: EUS-guided laser ablation of the pancreas with an Nd:YAG laser is feasible in a porcine model.

Endoscopic full-thickness resection of superficial colorectal neoplasms using a new over-the-scope clip system: A single-centre study.

BACKGROUND AND AIM: Endoscopic full-thickness resection (EFTR) provides complete en-bloc resection with a histopathological evaluation of submucosal, muscular, and serosal layers. The aim of this study was to investigate the efficacy and safety of a novel over-the-scope device for colorectal EFTR. MATERIAL AND METHODS: In this retrospective, observational, open-label case study, a total of 20 patients with superficial colorectal neoplasms, underwent EFTR using a new endoscopic full-thickness resection device (FTRD; Ovesco Endoscopy, Tübingen, Germany). Endoscopic treatment outcomes (technical success, rate of EFTR, adverse events) and early follow-up at three months, were analyzed. RESULTS: We reported a 100% of technical success, defined as full-thickness resection. Among the R1 resections, histology was negative for neoplasm. Non-lifting adenomas had histology positive for adenocarcinoma: seven T1/G1/sm1; one T1/G1/sm2; one, who underwent a surgical resection, T1/G1/sm3. Mean size of the resected lesions was 26mm, ranging from 10 to 42mm. One (5%) patient developed abdominal pain, fever and leukocytosis and was treated conservatively with medical therapy. In all specimens, histological complete resection was confirmed. CONCLUSIONS: EFTR is a feasible and effective technique that could become a valid alternative to EMR and ESD in the management of recurrent adenomas, no-lifting lesions and scars of R1 resections. However, prospective studies are needed to further evaluate the device and technique.

Sems (self expanding metal stents) in a patient with esophagogastric cancer and esophagorespiratory fistula (ERF).

Esophagorespiratory fistulas, especially in the upper third of the esophagus, are a complication of malignant esophageal tumors, whose management is difficult and prognosis is poor. Treatment is palliative and involves restoration of the ability to ingest food and prevention of aspiration by insertion of esophageal or tracheobronchial stents. In selected patients the insertion of a single stent may be insufficient for pallation therefore the placement of parallel stents may be indicated in patients with symptoms caused by malignant esophagorespiratory fistula. A case of esophagorespiratory fistula managed with insertion of parallel stents is presented.

Sems (self expanding metal stents) in palliation of esophageal cancer dysphagia.

Symptomatic inoperable esophageal carcinoma represents a major clinical problem. With no treatment, swallowing deteriorates with a dramatic worsening of quality of life. At present, self-expanding metal stents (SEMS) are the most effective non surgical palliation in inoperable esophageal cancer. The different types of available SEMS, techniques, results and complications are discussed.

Theoretical analysis and experimental evaluation of laser-induced interstitial thermotherapy in ex vivo porcine pancreas.

Laser-induced interstitial thermotherapy (LITT) has been recently applied to pancreas in animal models for ablation purpose. Assessment of thermal effects due to the laser-pancreatic tissue interaction is a critical factor in validating the procedure feasibility and safety. A mathematical model based on bioheat equation and its experimental assessment was developed. The LITT procedure was performed on 40 ex vivo porcine pancreases, with an Nd:YAG (1064 nm) energy of 1000 J and power from 1.5 up to 10 W conveyed by a quartz optical fiber with 300 µm diameter. Six fiber Bragg grating sensors have been utilized to measure temperature distribution as a function of time at fixed distances from the applicator tip within pancreas undergoing LITT. Simulations and experiments show temperature variations Δ T steeply decreasing with distance from the applicator at higher power values: at 6 W, ∆T > 40 °C at 5 mm and Δ T is approximately equal to 5 °C at 10 mm. Δ T nonlinearly increases with power close to the applicator. Ablated and coagulated tissue volumes have also been measured and experimental results agree with theoretical ones. Despite the absence of data in the current literature on pancreas optical parameters, the model allowed a quite good prediction of thermal effects. The prediction of LITT effects on pancreas is necessary to assess laser dosimetry.

Efficacy of main pancreatic-duct endoscopic drainage in patients with chronic pancreatitis, continuous pain, and dilated duct.

BACKGROUND: The aim of endoscopic treatment in patients with chronic pancreatitis is to achieve decompression of the pancreatic duct, because duct obstruction with increased pressure within the duct is one of the leading causes of pain in these patients. The majority of patients suffer from relapsing pain, thus making it difficult to evaluate the efficacy of therapy. The outcome of endoscopic treatment on pain has been evaluated in patients with continuous pain (present for more than 1 month, at least 5 days per week, requiring daily analgesic therapy) and dilated duct. METHODS: Of 343 patients who underwent endotherapy for chronic pancreatitis in a 15-year period, 22 (6.4%)(19 men, mean age 48 years, alcohol abuse 14) had continuous pain and a dilated pancreatic duct. RESULTS: Endotherapy was successful in all patients, with no procedure-related mortality and only mild complications. Pain disappeared, and analgesics could be discontinued in all patients immediately after endotherapy. Six patients are pain free after a mean period of 5.5 years. One pain-free patient died after 3.4 years from myocardial infarction. Five patients were successfully endoscopically re-treated for pain relapses. Four patients underwent surgery for frequent pain relapses after a mean period of 2.5 years. Six patients were lost to follow-up. CONCLUSIONS: Endotherapy should be considered as the initial treatment of choice in patients with chronic pancreatitis, dilated duct, and continuous pain.