Digital single-operator pancreatoscopy for the treatment of symptomatic pancreatic duct stones: a prospective multicenter cohort trial.

BACKGROUND: Digital single-operator pancreatoscopy (DSOP)-guided lithotripsy is a novel treatment modality for pancreatic endotherapy, with demonstrated technical success in retrospective series of between 88 % and 100 %. The aim of this prospective multicenter trial was to systematically evaluate DSOP in patients with chronic pancreatitis and symptomatic pancreatic duct stones. METHODS: Patients with symptomatic chronic pancreatitis and three or fewer stones ≥ 5mm in the main pancreatic duct (MPD) of the pancreatic head or body were included. The primary end point was complete stone clearance (CSC) in three or fewer treatment sessions with DSOP. Current guidelines recommend extracorporeal shock wave lithotripsy (ESWL) for MPD stones > 5 mm. A performance goal was developed to show that the CSC rate of MPD stones using DSOP was above what has been previously reported for ESWL. Secondary end points were pain relief measured with the Izbicki pain score (IPS), number of interventions, and serious adverse events (SAEs). RESULTS: 40 chronic pancreatitis patients were included. CSC was achieved in 90 % of patients (36/40) on intention-to-treat analysis, after a mean (SD) of 1.36 (0.64) interventions (53 procedures in total). The mean (SD) baseline IPS decreased from 55.3 (46.2) to 10.9 (18.3). Overall pain relief was achieved in 82.4 % (28/34) after 6 months of follow-up, with complete pain relief in 61.8 % (21/34) and partial pain relief in 20.6 % (7/34). SAEs occurred in 12.5 % of patients (5/40), with all treated conservatively. CONCLUSION: DSOP-guided endotherapy is effective and safe for the treatment of symptomatic MPD stones in highly selected patients with chronic pancreatitis. It significantly reduces pain and could be considered as an alternative to standard ERCP techniques for MPD stone treatment in these patients.

[G-POEM - Gastric Peroral Endoscopic Myotomy as a Therapy Option for Chronic Gastric Emptying Disorders]. / G-POEM ­ Gastrale perorale endoskopische Myotomie als Therapieoption bei chronischer Magenentleerungsstörung.

Many doctors and patients shy away from the surgical intervention of a pyloromyotomy using laparoscopy. The effectiveness of botulinum toxin injections into the pylorus has not been established 1 2. Pharmacological therapeutic approaches are unsatisfactory and show a wide range of side effects 3. G-POEM is a procedure that has proven its feasibility with a low complication rate. A relatively high response could be documented in previous publications 4. The long-term successes are still being discussed controversially 5. After the initial euphoria, the problem of patient selection comes to the fore. The symptoms, as well as the pathophysiology of gastric emptying disorder, are diverse 6. The diagnostic tests available do not reflect the variability of the disease 7 8 9 10. The postoperative gastric emptying disorder seems to be an exception. G-POEM can protect both therapists and patients from another invasive procedure.

Diagnostic and therapeutic single-operator cholangiopancreatoscopy with SpyGlassDS™: results of a multicenter retrospective cohort study.

BACKGROUND AND AIMS: The aim of the study was to evaluate the usefulness and diagnostic and therapeutic outcome of the single-operator cholangiopancreatoscopy (SOC) with SpyGlassDS™. METHODS: In a retrospective multicenter study between November 2015 and January 2017, SpyGlassDS™ procedures were analyzed in participating centers. Indications, accuracy of SOC-guided biopsies, management of large bile duct stones, and complications were analyzed. Follow-up was 4 months. RESULTS: Two hundred and six patients out of 250 examinations were evaluated. Indications were biliary stones (n = 132), bile duct stenosis (n = 93), stones and stenosis combined (n = 24), and bile duct leakage (n = 1). Of the 117 cases which were suspicious of malignancy, in 99 cases the lesion could be stratified into benign (n = 55) or malignant (n = 44) indicating a sensitivity of 95.5% and a specificity of 94.5% for the indication tumor. SOC-guided biopsies revealed a sensitivity of 57.7% with a specificity of 100%. In 107 examinations, biliary stones were visualized and could be completely removed in 91.1% with a need of three procedures (range 1-6) to achieve final stone clearance. In 75 cases, lithotripsy was performed and was successful in 71 cases (95%). Four out of 45 patients (8.9%) underwent cholecystectomy with surgical bile duct revision as a final therapy. Adverse Event (AE) occurred in 33/250 patients (13.2%) and Serious Adverse Event (SAE) occurred in 1/250 patients (0.4%). Cholangitis was 1% (n = 102) after peri-interventional administration of antibiotics and 12.8% (n = 148) without antibiotic prophylaxis (p < 0.001). CONCLUSIONS: SOC with SpyGlassDS™ became a new standard for the diagnosis of indefinite biliary lesions and therapy of large bile duct stones. The diagnostic yield of SOC-guided biopsies facilitated a definite diagnosis in most cases and should be improved by standardized biopsy protocols. SOC-guided interventions allowed removal of large biliary stones by SOC-guided lithotripsy. The complication rate of 13.2% can be considerably reduced by use of a single-shot antibiotic treatment.

Control measures following a case of imported Lassa fever from Togo, North Rhine Westphalia, Germany, 2016.

In a patient transferred from Togo to Cologne, Germany, Lassa fever was diagnosed 12 days post mortem. Sixty-two contacts in Cologne were categorised according to the level of exposure, and gradual infection control measures were applied. No clinical signs of Lassa virus infection or Lassa specific antibodies were observed in the 62 contacts. Thirty-three individuals had direct contact to blood, other body fluids or tissue of the patients. Notably, with standard precautions, no transmission occurred between the index patient and healthcare workers. However, one secondary infection occurred in an undertaker exposed to the corpse in Rhineland-Palatinate, who was treated on the isolation unit at the University Hospital of Frankfurt. After German authorities raised an alert regarding the imported Lassa fever case, an American healthcare worker who had cared for the index patient in Togo, and who presented with diarrhoea, vomiting and fever, was placed in isolation and medevacked to the United States. The event and the transmission of Lassa virus infection outside of Africa underlines the need for early diagnosis and use of adequate personal protection equipment (PPE), when highly contagious infections cannot be excluded. It also demonstrates that larger outbreaks can be prevented by infection control measures, including standard PPE.

Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.

BACKGROUND AND STUDY AIMS: Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. PATIENTS AND METHODS: A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.  RESULTS: Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (< 8 weeks after placement) occurred in 8 patients (50 %) vs. 2 patients (11.1 %), respectively (P = 0.022). After obtaining the results from this interim analysis, the study was discontinued because of safety concerns. CONCLUSIONS: The frequency of stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634).

VACStent: Combining the benefits of endoscopic vacuum therapy and covered stents for upper gastrointestinal tract leakage.

Background and study aims Endoscopic treatment has markedly improved the high morbidity and mortality in patients with upper gastrointestinal tract leakage. Most procedures employ either covered self-expanding metal stents (SEMS) or endoscopic vacuum therapy (EVT), both with good clinical success but also with concomitant significant shortcomings inherent in each technique. A newly developed device, the VACStent, combines the fully covered SEMS with a polyurethane sponge cylinder anchored on the outside. This allows endoluminal EVT while keeping the intestinal lumen patent. The benefit is prevention of stent migration because the suction force of the sponge-cylinder immobilizes the VACStent on the intestinal wall, while at the same time, the attached external vacuum pump suctions off any secretions and improves healing with negative-pressure wound treatment (NPWT). Patients and methods In this pilot study, the first patients to receive the VACStent were assessed. Outcomes included the applicability and stability of the VACStent system together with the clinical course. Results Three patients with different clinical courses were managed with the VACStent. The first patient suffered anastomotic leakage following subtotal esophagectomy and was successfully treated with two postoperative VACStents for 12 days. The second patient received a covered SEMS for 14 days for acute Boerhaave syndrome. Due to persistent leakage, management was converted to EVT. Seven days, later a VACStent was inserted to allow oral nutrition while the leak finally closed. In the third patient, a LINX Reflux Management System had to be removed for erosion, leaving the gastroesophageal junction (GEJ) with a full-thickness gap. After VACstent insertion, successful closure was achieved within 4 days. Conclusions These clinical cases demonstrate the applicability and efficacy of the VACstent in management of esophageal and anastomotic leakage. With its vacuum sponge, the stent fosters wound healing while the covered SEMS keeps the passage patent for nutrition.

Clinical practice patterns in indirect peroral cholangiopancreatoscopy: outcome of a European survey.

Background and aims Indirect peroral cholangiopancreatoscopy (IPOC) is a relatively new diagnostic and therapeutic tool for biliopancreatic diseases. This international survey aimed to evaluate clinical practice patterns in IPOC among endoscopists in Europe. Methods An online survey was developed comprising 66 questions on the use of IPOC. Questions were grouped into four domains. The survey was sent to 369 endoscopists who perform IPOC. Results 86 respondents (23.3 %) from 21 different countries across Europe completed the survey. The main indications for cholangioscopy were determination of biliary strictures (85 [98.8 %]) and removal of common bile duct or intrahepatic duct stones (79 [91.9 %]), accounting for an estimated use of 40 % (interquartile range [IQR] 25-50) and 40 % (IQR 30-60), respectively, of all cases undergoing cholangioscopy. Pancreatoscopy was mainly used for removal of pancreatic duct stones (68/76 [89.5 %]), accounting for an estimated use of 76.5 % (IQR 50-95) of all cases undergoing pancreatoscopy. Only 13/85 respondents (15.3 %) had an institutional standardized protocol for targeted cholangioscopy-guided biopsy sampling. IPOC with lithotripsy was used as first-line treatment in selected patients with bile duct stones or pancreatic stones by 24/79 (30.4 %) and 53/68 (77.9 %) respondents, respectively. Conclusions This first European survey on the clinical practice of IPOC demonstrated wide variation in experience, indications, and techniques. These results emphasize the need for prospective studies and development of an international consensus guideline to standardize the practice and quality of IPOC.

A new approach to endoscopic treatment of tumors of the esophagogastric junction with individually designed self-expanding metal stents.

The incidence of adenocarcinoma of the esophago-gastric junction is constantly increasing. Curative treatment is no longer possible at the time of diagnosis in more than 50% of patients with esophageal carcinoma, and palliative treatment focusing on eliminating dysphagia is required. Endoscopic therapy with stent implantation is an established method of achieving this. It can be carried out quickly, with a low rate of early complications, and leads to fast symptomatic improvement, assessed using the dysphagia score. The relatively high rate of late complications such as stent migration, hemorrhage, and gastroesophageal mucosal prolapse has led to recent debate on the role of metal stents in palliative therapy. We present here a new type of stent design for transcardial application, which is intended to prevent bleeding due to mechanical mucosal lesions caused by the distal end of the stent extending into the stomach. The further intention of this case report is to force the discussion on individually designed nitinol stents in special anatomic conditions.

Comparison of removal techniques in the management of buried bumper syndrome: a retrospective cohort study of 82 patients.

BACKGROUND AND STUDY AIMS: Buried bumper syndrome is an infrequent complication of percutaneous endoscopic gastrostomy (PEG) that can result in tube dysfunction, gastric perforation, bleeding, peritonitis or death. The aim of this study was to compare the efficacy of different PEG tube removal methods in the management of buried bumper syndrome in a large retrospective cohort. PATIENTS AND METHODS: From 2002 to 2013, 82 cases of buried bumper syndrome were identified from the databases of two endoscopy referral centers. We evaluated the interval between gastrostomy tube placement and diagnosis of buried bumper syndrome, type of treatment, success rate and complications. Four methods were analyzed: bougie, grasp, needle-knife and minimally invasive push method using a papillotome, which were selected based on the depth of the buried bumper. RESULTS: The buried bumper was cut free with a wire-guided papillotome in 35 patients (42.7 %) and with a needle-knife in 22 patients (26.8 %). It could be pushed into the stomach with a dilator without cutting in 10 patients (12.2 %), and was pulled into the stomach with a grasper in 12 patients (14.6 %). No adverse events (AEs) were registered in 70 cases (85.4 %). Bleeding occurred in 7 patients (31.8 %) after cutting with a needle-knife papillotome and in 1 patient (8.3 %) after grasping. No bleeding was recorded after using a standard papillotome or a bougie ( P  < 0.05). Ten of 22 patients (45.5 %) treated with the needle-knife had a serious AE and 1 patient died (4.5 %). CONCLUSIONS: We recommend that incomplete buried bumpers be removed with a bougie. In cases of complete buried bumper syndrome, the bumper should be cut with a wire-guided papillotome and pushed into the stomach.

Case Report: Human Bocavirus Associated Pneumonia as Cause of Acute Injury, Cologne, Germany.

Although the human bocavirus (HBoV) is known since a decade, limited information about its pathogenesis is available due to the lack of an animal model. Thus, clinical cases and studies are the major source of novel information about the course of infection and the related pathophysiology.In this context, a clinical case of an adult patient suffering from severe HBoV-pneumonia is described that was associated with loss of consciousness followed by acute rib fracture and subsequent neurological disorder.Following initial global respiratory dysfunction the clinical respiratory symptoms recovered but the neurological symptoms maintained after weaning and intensive care in the stroke unit. During the initial phase, an acute active HBoV infection was confirmed by positive polymerase chain reactions from bronchoalveolar lavage fluid and serum.The case further demonstrates that HBoV can cause severe pneumonia, induce secondary disease also in adults, and may be associated with neurological symptoms as previously assumed.

Survey on structure and performance of nutrition-support teams in Germany.

BACKGROUND & AIMS: Interdisciplinary nutrition-support teams (NSTs) can improve the efficacy of clinical nutrition. The purpose of this survey was to investigate the prevalence, and structure of German NSTs. METHOD: Hospitals in Germany with more that 250 beds were screened for the existence of NSTs. Eligible NSTs were interviewed about structural characteristics, administration of clinical nutrition and quality control in a face-to-face manner using a standardised questionnaire. RESULTS: A total of 47 NSTs existed in Germany revealing a prevalence of 5.6%. Their main activities were creating nutritional regimens (100%), education (98%) and monitoring nutrition therapy (96%). Twenty-two of NST-physicians (50%) had a specific education as compared to 20.9% NST-nurses and 24% NST-dietitians. Only 12.7% of physicians and 17% of dieticians in comparison to 55.3% of nurses received funding support. Improvement of clinical nutrition by means of increased use of enteral nutrition and special diets was indicated by 72%, 23%, respectively. Some NSTs indicated a reduction of complications (38.3%) and cost-saving (34%) since their establishment. CONCLUSIONS: There is a low prevalence of interdisciplinary NSTs in Germany. Standards of practice, development of guidelines in clinical nutrition and better documentation in NSTs are necessary. Special efforts should be aimed at education of NST members and financing of teams.

Long-term results with a new introducer method with gastropexy for percutaneous endoscopic gastrostomy.

OBJECTIVE: Percutaneous endoscopic gastrostomy (PEG) using the pull-technique is the standard method for enteral feeding in patients with swallowing disorders. A different introducer technique with endoscopically controlled gastropexy is available avoiding oropharyngeal passage with the internal bumper. The aim of the study was to assess long-term safety of this technique. MATERIAL AND METHODS: Between January 1999 and November 2001, 684 patients received a PEG in our prospective cohort trial. In 92.5% of cases a PEG was applied using the pull-through technique. In 6.7% of the patients (40 males, 6 females, mean age 60.6 yr) primary PEG application using the pull-through technique was not possible and an endoscopical controlled introducer PEG (Cliny PEG 13 CH (=13 F), AP Nenno, Germany) with two gastropexies was placed. Data collection criteria included application success, infectious complications (within 180 days), other complications (within 180 days), and mortality (within 180 days). Procedure, catheter change, and follow-up were standardized. RESULTS: PEG placement was successful in all patients. During initial follow-up we saw a low rate of minor problems. In one case a peristomal peritonitis was seen due to detachment of two gastropexy sutures. During long-term follow-up only one local infection requiring antibiotic treatment occurred on day 14. We observed no treatment related mortality. In most of the patients the primary catheter was changed into a secondary system as scheduled. The average observation period was 131.8 days (range: 15-180 days). CONCLUSION: The Cliny PEG 13 CH can be placed safely in an endoscopically controlled introducer procedure with dual gastropexy. Long-term follow-up of the patients revealed only minor complications. Primary indication is given in patients in whom PEG placement using the pull-through technique is not possible.

Self-expanding plastic stents for benign esophageal lesions.

BACKGROUND: A benign condition is a relative contraindication to the use of self-expanding metallic stents, because these devices usually are not retrievable. The self-expanding plastic stent is removable and induces less tissue hyperplasia. This study prospectively evaluated the use of a self-expanding plastic stent to treat benign esophageal conditions. METHODS: Over 4 years, 21 patients underwent self-expanding plastic stent placement for various benign esophageal disorders, including refractory peptic (n = 2), caustic (n = 3), post-radiotherapy (n = 3), and anastomotic (n = 4) stenoses; hyperplastic (n = 5) stenosis within a previously implanted metallic stent; and anastomotic leak (n = 4) after esophagectomy. The self-expanding plastic stent was removed from all patients. Patients were followed for at least 8 months after stent removal. RESULTS: Implantation was successful in all cases. Temporary self-expanding plastic stent placement was curative in 17/21 patients, especially those with caustic and hyperplastic strictures and anastomotic fistula, all of which were treated successfully without re-intervention. Median follow-up was 21 months (range 8-39 months) after stent removal. Moreover, by inducing tissue ischemia, self-expanding plastic stent allowed delayed removal of metallic stents. Only one severe complication (tracheal compression) was encountered, and this resolved after stent removal. CONCLUSIONS: A range of benign stenosing disorders of the esophagus can be treated safely with a self-expanding plastic stent. Because the long-term results were highly favorable, self-expanding plastic stent placement could be used as the initial treatment for various conditions. Self-expanding plastic stent insertion within an esophageal self-expanding metallic stent allowed removal of the latter, theoretically unretrievable, stent.