Clinical implantation of 92 VACStents in the upper gastrointestinal tract of 50 patients-applicability and safety analysis of an innovative endoscopic concept.

Introduction: Endoscopic vacuum therapy (EVT) has emerged as a promising treatment option for upper gastrointestinal wall defects, offering benefits such as evacuation of secretions and removal of wound debris by suction, and reduction and healing of wound cavities to improve clinical outcomes. In contrast, covered stents have a high rate of migration and lack functional drainage, while endoluminal EVT devices obstruct the GI tract. The VACStent is a novel device that combines the benefits of EVT and stent placement. Its design features a fully covered Nitinol-stent within a polyurethane sponge cylinder, enabling EVT while maintaining stent patency. Methods: This study analyzes the pooled data from three different prospective study cohorts to assess the safe practicality of VACStent placement, complete leak coverage, and effective suction-treatment of esophageal leaks. By pooling the data, the study aims to provide a broader base for analysis. Results: In total, trans-nasal derivation of the catheter, suction and drainage of secretion via vacuum pump were performed without any adversity. In the pooled study cohort of 92 VACStent applications, the mean stent indwelling time was 5.2 days (range 2-8 days) without any dislocation of the device. Removal of the VACStent was done without complication, in one case the sponge was lost but subsequently fully preserved. Minor local erosions and bleeding and one subsequent hemostasis were recorded unfrequently during withdrawal of the device (5.4%, 5/92) but no perforation or pressure ulcer. Despite a high heterogeneity regarding primary disease and pretreatments a cure rate of 76% (38/50 patients) could be achieved. Discussion: In summary, insertion and release procedure was regarded as easy and simple with a low potential of dislocation. The VACStent was well tolerated by the patient while keeping the drainage function of the sponge achieving directly a wound closure by continuous suction and improving the healing process. The implantation of the VACStent provides a promising new procedure for improved clinical treatment in various indications of the upper gastrointestinal wall, which should be validated in larger clinical studies.Clinical Trial Registration: Identifier [DRKS00016048 and NCT04884334].

The VACStent trial: combined treatment of esophageal leaks by covered stent and endoscopic vacuum therapy.

BACKGROUND: Endoscopic treatment of esophageal leaks, mostly by covered stents or endoscopic vacuum therapy (EVT), has largely improved the clinical outcome in the last decade. However, both techniques suffer from significant limitations. Covered stents are hampered by a high rate of migration and missing functional drainage, whereas endoluminal EVT devices are limited by obstruction of the GI tract. The new design of the VACStent makes it a fully covered stent within a polyurethane sponge cylinder, allowing EVT while stent passage is still open. Initial clinical applications have demonstrated the fundamental concept of the VACStent. METHOD: A prospective multicenter open-label study was performed with the primary endpoint safe practicality, complete leak coverage, and effective suction-treatment of esophageal leaks. Secondary endpoints were prevention of septic conditions, successful leak healing, and complications, in particular stent-migration, local erosions and bleeding. RESULTS: Fifteen patients with different, mostly postoperative anastomotic leaks were enrolled in three centers. A total of 41 VACStents were implanted. The mean number of VACStents per patient was 2.7, with a mean duration of VACStent treatment of 15 days. The primary endpoint was met in all VACStent applications (41/41 implants), resulting in a leak healing rate of 80% (12/15 patients). Septic episodes were prevented in 93% (14/15 patients) and there was no mortality. There were no severe device-related adverse events (SADE) nor significant local bleeding or erosion. Minor stent-dislocation and migration, respectively, was observed in 7%. Oral intake of liquids or food was documented in 87% (13/15 patients). One anastomotic stenosis was seen during follow-up. CONCLUSIONS: VACStent treatment is a safe and effective treatment in esophageal leaks which can be covered by the sponge cylinder. Its application was described as easy and resembling that of conventional GI stents, with an impressive clinical success rate comparable to EVT outcomes. The VACStent offers a new option for clinical treatment of critical situations in esophageal perforations and anastomotic sutureline failures.

Experience with fully covered self-expandable metal stents for anastomotic stricture following esophageal atresia repair.

There is a lack of experience with fully covered self-expandable metal stents (SEMSs) for the treatment of benign esophageal conditions in the pediatric population. This is the evaluation of our institutional experience of placing SEMSs for anastomotic stricture (AS) formation following esophageal atresia (EA) repair. Patients were jointly managed from the Department of Pediatric Surgery and Central Interdisciplinary Endoscopy at our institution. Thirteen children (8 male, 5 female) with a median age of 4 months (range: 1-32 months) who underwent treatment with SEMSs for a postoperative AS following EA repair between February 2006 and April 2016 were recruited into this retrospective study. SEMSs that are originally designed for other organs such as trachea, bronchus, biliary tract, or colon were inserted under general anesthesia via endoscopic guidance. Simultaneous fluoroscopy was not required in any case. In five infants, the stents were inserted primarily without previous therapy. Seven patients underwent stenting following dilatation with or without adjuncts (e.g. Mitomycin C, Triamcinolone). In one case with an AS and a simultaneous persistent tracheoesophageal fistula (TEF), multiple SEMSs were applied after failure to close the fistula with fibrin glue.The median duration of individual stent placement was 30 days (range: 5-91 days). In five children up to four different biliary, bronchial or colonic SEMSs were placed successively over time. There were no problems noted at stent insertion or removal. Eight children (62%) developed complications associated with stenting. At follow-up, in eight patients (62%) AS was resolved, including all of those five cases, who had their stents inserted without previous therapy. Five children (38%), who underwent dilatation prior to stenting did not improve their AS and required further intervention. Overall, the cohort exhibited a slight, but not significant weight gain between stent insertion and (final) stent removal.Insertion of SEMSs for AS following EA repair is safe and often successful with only one single application. It can be used as a primary procedure (without previous therapy) or after failed dilatations.There was one death in this study that was unrelated to stenting and occurred 12 months after stent removal. Because of the absence of manufactured, age-related devices, SEMSs that are originally designed for other organs can be applied. Establishment of a standardized management including stent placement for the treatment of AS following EA repair in the pediatric population is required.

[NOTES in visceral surgery : Current status]. / NOTES-Operationen in der Viszeralchirurgie : Aktueller Stand.

The idea to use natural orifices as an access route for operations in the body has inspired many clinicians and researchers worldwide. Some of these expected a continuation of the development from open surgery to laparoscopic surgery finally to a less invasive modality. Others hoped for economic benefits for endoscopists to take over previous surgical patients into gastroenterological departments. The first experimental studies demonstrated that the initial expectations could not be implemented in a short period of time. The available endoscopes could not be proved for advanced procedures. Key problems like sterility, infection control, tissue manipulation, safety of access closure, and specimen retrieval manifested to be too large for routine clinical use. However, the attraction of the natural orifice transluminal endoscopic surgery (NOTES) philosophy has resulted in a reduction of the number and diameters of trocars in laparoscopic surgery. Hybrid NOTES as a combination of classical laparoscopic access with natural orifice instrumentations (mostly transvaginal) have become clinical reality in many hospitals. This development fits into the long-term trend towards less invasive surgery and more effective interventional methods in endolumenal endoscopy.

[Therapy of paediatric pancreatic trauma]. / Therapie traumatischer Pankreasverletzungen im Kindesalter.

BACKGROUND: The goal of this clinical study is to evaluate diagnostics and therapeutical strategies for paediatric pancreatic trauma. It is assumed that conservative treatment is at least as good as operative treatment. PATIENTS / MATERIAL AND METHODS: In a retrospective study 36  children with pancreatic trauma treated between the years 1987 and 2010 in the paediatric surgery department of the University Medical Centre Mannheim were included. Injury grades, diagnostics and treatment were evaluated. RESULTS: In a collective of 36  patients with an average age of seven years the following injuries were found: 26  grade 1, three grade  2, five grade  3 and two grade  4 injuries. Eight patients presented with polytrauma, 20 showed additional injuries. Initial levels of amylase and lipase and screening ultrasound were not always sensitive. 18  patients received conservative treatment. The remaining 18  were operated: either exploratory laparotomy and drainage or pancreas reconstruction with inner stenting or distal pancreatic resection were performed. Pancreatic pseudocysts were drained by transgastric stenting. CONCLUSION: 20 years ago blunt pancreatic trauma was usually treated operatively. Today grade 1 and grade 2 injuries should be treated conservatively. Higher graded pancreatic ductal injuries can be managed operatively with ductal stenting and organ conservation. Pancreatic resections are not always necessary. Endoscopic transgastric drainage of persisting pancreatic pseudocysts is also successful in children.

[New ways in the surgery of acute appendicitis?]. / Neue Wege in der operativen Behandlung der akuten Appendizitis?

Acute appendicitis is still one of the most common abdominal emergencies necessitating operative treatment. For the past century, the conventional management of appendicitis has been open appendectomy. Since the introduction of laparoscopic appendectomy, it has been performed with increased frequency. Clinical trials evaluating outcomes comparing open appendectomy with laparoscopic appendectomy indicate that laparoscopic appendectomy is associated with lower complication rate and lower mortality and is to be considered the procedure of choice for patients with suspected acute appendicitis. Ever since Kalloo's first report on transgastric peritoneoscopy in a porcine model in 2004, this dramatic surgical revolution has prompted many surgeons and endoscopists to study this new technique. This complex technique involves breaching the wall of a hollow organ to gain access into the peritoneum: Natural Orifice Translumenal Endoscopic Surgery (NOTES). In recent years, several NOTES experiments have been carried out in animal models and even on humans, including appendectomy. NOTES may help to reduce surgical pain and shorten recovery time. The concept of NOTES has generated intensive interest in the medical community as well as in the group of patients. Although the novel procedure is still far from being mature and many technical problems have to be overcome and more clinical studies have to be done before its widespread application in human appendectomy, NOTES is a promising procedure for the future.

[Endoscopic resection of early carcinoma of the gastroesophageal junction]. / Endoskopische Resektion beim Frühkarzinom des gastroösophagealen Überganges.

The endoscopic examination of the gastroesophageal junction focuses on confirmation of neoplastic lesions or precursors. Recent technical advances, such as high resolution video endoscopes and chromoendoscopy may improve the sensitivity of endoscopic diagnosis. Biopsies are still a necessary part of the examination, however, they may be not representative for the lesion and should be replaced by a complete endoscopic resection wherever possible. If the histopathological examination reveals a well differentiated carcinoma without microlymphatic and microvenous infiltration with tumor-free resection margins which is limited to the mucosa, endoscopic resection can be regarded as curative. While tumor infiltration depth and differentiation are determined by the tumor biology, complete resection can be achieved by a sophisticated endoscopic technique which requires vast experience and extensive equipment.

Gastrointestinal endoscopy in a low budget context: delegating EGD to non-physician clinicians in Malawi can be feasible and safe.

Gastrointestinal endoscopy is rarely performed in low-income countries in sub-Saharan Africa. One reason is the lack of available medical doctors and specialists in these countries. At Zomba Central Hospital in Malawi, clinical officers (non-physician clinicians with 4 years of formal training) were trained in upper gastrointestinal endoscopy. Prospectively recorded details of 1732 consecutive esophagogastroduodenoscopies (EGDs) performed between September 2001 and August 2010 were analyzed to evaluate whether upper gastrointestinal endoscopy can be performed safely and accurately by clinical officers. A total of 1059 (61.1%) EGDs were performed by clinical officers alone and 673 (38.9%) were carried out with a medical doctor present who performed or assisted in the procedure. Failure and complication rates were similar in both groups (P=0.105). Endoscopic diagnoses for frequent indications were generally evenly distributed across the two groups. The main difference was a higher proportion of normal findings and a lower proportion of esophagitis in the group with a doctor present, although this was significant only in patients who had presented with epigastric/abdominal pain (P<0.001). In conclusion, delegating upper gastrointestinal endoscopy to clinical officers can be feasible and safe in a setting with a shortage of medical doctors when adequate training and supervision are provided.

Selective tissue elevation by pressure for endoscopic mucosal resection of colorectal adenoma: first clinical trial.

BACKGROUND: Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection of large lateral spreading tumors currently are technically limited by complications such as bleeding, perforation, and disturbed large procedural sites, leading to incomplete resection and secondary surgery. Further technical improvements are necessary. The authors previously demonstrated the effectiveness of a focused water jet for elevation of the lamina submucosa in animal studies. For the first time, the clinical application of selective tissue elevation by pressure (STEP) for the treatment of colorectal adenomas as a prospective single-arm human trial is presented. METHODS: This trial evaluated 59 patients who had primary colorectal adenomas with diameters exceeding 12 mm classified as 0-IIa or 0-IIb according to Paris classification. A submucosal cushion was created with a flexible water jet applicator using the Helix HydroJet. The adenoma was subsequently resected with a mucosal resection snare. All results were recorded. The resected specimens were assessed histologically. RESULTS: A total of 59 patients underwent resection of 70 lesions with a maximum diameter of 80 mm (mean, 27 mm). Submucosal elevation with the water jet dissector was possible in all cases and locations from the pectinate line to the ileocecal valve. Of the 70 lesions, 64 (91%) were resected completely in one session. Histologically, the resected specimens were found to be adenocarcinomas (n = 2, 3%), adenomas with high-grade intraepithelial neoplasia (n = 24, 34%), adenomas with low-grade intraepithelial neoplasia (n = 38, 54%), and hyperplastic polyps (n = 6, 9%). Hemostasis during the resection was necessary in 24 cases (34%). No perforation required surgical intervention. CONCLUSION: This first clinical trial to analyze STEP technique demonstrated that STEP used to elevate large mucosal lesions in any location is feasible and facilitates EMR for colorectal adenoma.

[Disappearing borders in visceral medicine]. / Schwindende Fachgebietsgrenzen in der Viszeralmedizin.

The structure of disciplines in human medicine is in a constant state of flux. The dominating processes in the past were specialization and differentiation but nowadays we are faced with a new phenomena: new combinations of specialties which are dealing with the same organ systems and therefore the relationships have to be restructured. In many fields this re-defining process is unspectacular but between gastroenterology and abdominal surgery there are above-average problems which need to be analyzed.The overlap between both fields is particularly large. While for many syndromes conservative and operative dominated treatment concepts coexist, other methods such as ultrasound-guided interventions and endoscopic interventions are of common interest and overlap in the fields of both disciplines. The complex interactions between gastroenterology and gastrointestinal surgery make the necessary dialogue particularly difficult but for the same reasons rewarding.

[Toluidin blue in gastrointestinal endoscopy]. / Toluidinblau in der gastrointestinalen Endoskopie.

For decades, methylene blue has been used in gastrointestinal endoscopy as an absorbing dye, it was, however, not approved for that purpose and has now been withdrawn from the market. A possible substitute is toluidine blue, an acidophilic, metachromatic dye that selectively stains cell nuclei; accordingly, since 2007, toluidine blue has been approved as a topical diagnostic agent in chromoendoscopy. Cells with increased DNA synthesis are stained more intensively so that not only malignant cells but also erosions, ulcerations and inflammatory areas are stained with toluidine blue because of the increased reparative cellular processes. Up to now, absolutely no studies have been carried out with regard to the effectiveness of toluidine blue in gastrointestinal endoscopy. We report on a consecutive series of 364 endoscopic applications of toluidine made on the basis of various indications. Besides the known indications (e. g., chromoendoscopy in case of Barrett's oesophagus), we mostly used toluidine blue, diluted in hydroxyethylstarch (HAES), for submucosal injections of flat adenomas prior to endoscopic mucosal resection or endoscopic submucosal dissection, in order to precisely determine the extension of visible lesions. Local and systemic adverse reactions have not been observed. A demarcation of the lesions can be made as effectively as with methylene blue.

Effectivity of current sterility methods for transgastric NOTES procedures: results of a randomized porcine study.

BACKGROUND AND AIM: Natural-orifice transluminal endoscopic surgery (NOTES) is an emerging transluminal technique in which interventions are carried out by entering the abdominal cavity via a natural orifice such as the stomach. Infection is a potential risk of the procedure, and the potential pathogens are different from those encountered with skin incisions. Currently, available data regarding prophylactic anti-infective treatment are limited. We compared the effectiveness of topical antimicrobial lavage of mouth and stomach and proton pump inhibitor therapy with gastric cleansing with sterile saline solution in preventing NOTES-related contamination and infection. METHODS: A randomized survival swine study was performed. Eight pigs underwent preparation with intravenously administered proton pump inhibitors, mouth and gastric lavage (chlorhexidine), and gastric irrigation (diluted neomycin), plus single-shot intravenous antibiotics. Control group (n = 8) underwent gastric cleansing with sterile saline solution. Peritoneal biopsy, multiple smears, and dilutions for cultures were taken and incubated. The swine were sacrificed after 14 days. Bacterial load was expressed in colony-forming units (CFU). RESULTS: One pig died due to gallbladder perforation after 3 days, 2/15 swine presented minor clinical signs of infection in the 14-day follow-up (all 3 pigs were in the control group). Mean C-reactive protein levels were 5.7 +/- 2.4 g/dL (therapy group) and 12.2 +/- 3.8 g/dL (control) ( P = 0.17). Bacterial growth was seen in 1/8 swine (therapy group) and 6/8 swine (control group) ( P = 0.002). Bacterial load was 282 CFU/mL (therapy) vs. 3.2 x 10 (5) CFU/mL (control) ( P = 0.023) in the follow-up. CONCLUSION: The use of intravenous antibiotics in addition to topical antimicrobial lavage of mouth and stomach and treatment with proton pump inhibitors decreased the peritoneal bacterial load to almost zero and this was associated with a significantly lower peritoneal infection rate compared with saline-only lavage.

[Natural orifices transluminal endoscopic surgery (NOTES) in Germany: summary of the working group reports of the "D-NOTES meeting 2009"]. / Endoskopisches Operieren über natürliche Körperöffnungen (NOTES) in Deutschland: Zusammenfassung der Arbeitsgruppensitzungen der "D-NOTES 2009"

The D-NOTES-group met in June 2009 for an evaluation of ongoing preclinical and clinical activities in natural orifice endoscopic surgery and the further coordination of research in Germany. Different working groups with various topics were formed. Consensus statements among various participants with different scientific and medical background were initiated. In summary, important topics were handled such as the correct handling of bacterial contamination and related complications, the question of the ideal entry point and a secure closure, interdisciplinary cooperation, and matters related to training and education. Furthermore, participants agreed on terminological basics. A to-do-list for medical engineering was formulated.

[Evaluation of stents in treating childhood benign esophageal strictures]. / Evaluation von Stents zur Behandlung der benignen Osophagusstenose im Kindesalter.

BACKGROUND: Esophageal stenting is a popular of treatment of esophageal strictures in adults. It has also been described for children with benign strictures who did not respond to standard dilatation therapy. The aim of the study was to evaluate weather esophageal stents could be used safely and effectively in the treatment of benign esophageal strictures in children. PATIENTS: From 1993 to 2005 stenting therapy was performed in 12 children with complicated esophageal strictures. Etiologies of the strictures were caustic burns in 9 patients, postoperative strictures due to complicated esophageal atresia in 2 patients and iatrogenic esophageal injury in 1 patient. METHOD: Esophageal silicon tubi, covered retrievable expandable nitinol and plastic stents were placed endoscopically. The clinical course and the long term follow up were evaluated retrospectively RESULTS: The stents and tubi were placed in all patients without complications and were later removed successfully. 6 patients were treated with a self expanding plastic stent. The plastic stents showed a distinct tendency to migrate but in 5/6 patients esophageal stricture was treated successfully. 3 patients were treated by a covered self expanding nitinol stent. No migration occurred. One patient was asymptomatic after therapy, one required further dilatation therapy and the third had esophageal resection. 3 patients were treated by esophageal tubi. 2 patients required surgery in the follow up, one patient is asymptomatic. CONCLUSION: The use of stenting devices in children to treat benign esophageal strictures is safe and efficient. The self expanding plastic stents had the best long term results but required high compliance of parents and children due to the tendency of stent migration. Self expanding nitinol stents are more traumatic at the extraction procedure and are useful in patients with low compliance. Recurrence of strictures occurred most often after esophageal tubi possibly due to the lack of radial expansion.