Can Chromoendoscopy Improve the Early Diagnosis of Gastric Carcinoma in Dogs?

Chromoendoscopy has improved the early diagnosis of gastric cancer in humans but its usefulness in dogs is unknown. This study aimed at assessing whether adding narrow band imaging (NBI) or indigo carmine (IC) chromoendoscopy (CE) can improve the diagnostic yield of standard white light endoscopy (WLE). We compared the real-time findings of canine WLE, NBI-CE, and IC-CE and corresponding histology reports with endoscopic mucosal pattern assessment templates used in human medicine. Belgian Shepherd dogs are predisposed to gastric carcinoma. Therefore, 30 dogs of this breed served as the study population. According to histology, 17/30 dogs had mucosal changes (mucous metaplasia, glandular dysplasia, and gastric carcinoma). Diagnostic yield was best when targeted biopsies were taken with WLE and NBI-CE combined (15/17 cases). WLE alone positively identified only 8/17 cases and missed a gastric carcinoma in 3/6 cases. CE assessment templates based on macroscopic mucosal patterns, broadly used in human medicine, were not readily applicable in dogs. In conclusion, the study provides evidence that using CE in dogs has the potential to improve the diagnosis of precancerous gastric mucosal pathology and early gastric carcinoma. However, current image assessment templates from human medicine need major adjustments to the patterns of canine gastric mucosa.

Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020.

The following recommendations should only be applied after a thorough diagnostic evaluation including a contrast-enhanced computed tomography (CT) scan. 1 : ESGE recommends colonic stenting to be reserved for patients with clinical symptoms and radiological signs of malignant large-bowel obstruction, without signs of perforation. ESGE does not recommend prophylactic stent placement.Strong recommendation, low quality evidence. 2 : ESGE recommends stenting as a bridge to surgery to be discussed, within a shared decision-making process, as a treatment option in patients with potentially curable left-sided obstructing colon cancer as an alternative to emergency resection.Strong recommendation, high quality evidence. 3 : ESGE recommends colonic stenting as the preferred treatment for palliation of malignant colonic obstruction.Strong recommendation, high quality evidence. 4 : ESGE suggests consideration of colonic stenting for malignant obstruction of the proximal colon either as a bridge to surgery or in a palliative setting.Weak recommendation, low quality evidence. 5 : ESGE suggests a time interval of approximately 2 weeks until resection when colonic stenting is performed as a bridge to elective surgery in patients with curable left-sided colon cancer.Weak recommendation, low quality evidence. 6 : ESGE recommends that colonic stenting should be performed or directly supervised by an operator who can demonstrate competence in both colonoscopy and fluoroscopic techniques and who performs colonic stenting on a regular basis.Strong recommendation, low quality evidence. 7 : ESGE suggests that a decompressing stoma as a bridge to elective surgery is a valid option if the patient is not a candidate for colonic stenting or when stenting expertise is not available.Weak recommendation, low quality evidence.

European Society of Gastrointestinal Endoscopy - Establishing the key unanswered research questions within gastrointestinal endoscopy.

Background and study aim: Gastrointestinal endoscopy is a rapidly evolving research field. The European Society of Gastrointestinal Endoscopy (ESGE) plays a key role in shaping opinion and endoscopy activity throughout Europe and further afield. Establishing key unanswered questions within the field of endoscopy and prioritizing those that are important enables researchers and funders to appropriately allocate resources. Methods: Over 2 years, the ESGE Research Committee gathered information on research priorities and refined them through a modified Delphi approach. Consultations were held with the ESGE Governing Board and Quality Improvement Committee to identify important unanswered questions. Research workshops were held at the 21st United European Gastroenterology Week. Research questions were refined by the ESGE Research Committee and Governing Board, compiled into an online survey, and distributed to all ESGE members, who were invited to rank each question by priority. Results: The final questionnaire yielded 291 responses from over 60 countries. The three countries with the highest response rates were Spain, Italy, and United Kingdom. Most responders were from teaching hospitals (62 %) and were specialist endoscopists (51 %). Responses were analyzed with weighted rankings, resulting in prioritization of 26 key unanswered questions. The top ranked generic questions were: 1) How do we define the correct surveillance interval following endoscopic diagnosis? 2) How do we correctly utilize advanced endoscopic imaging? 3) What are the best markers of endoscopy quality? Conclusion: Following this comprehensive process, the ESGE has identified and ranked the key unanswered questions within the field of gastrointestinal endoscopy. Researchers, funders, and journals should prioritize studies that seek to answer these important questions.

[Transvaginal hybrid natural orifice transluminal endoscopic surgery cholecystectomy]. / Hybrid transvaginal natural orifice transluminal endoscopic surgerykolecystektomi.

Natural orifice transluminal endoscopic surgery (NOTES) is a minimally invasive surgical technique where access to the abdominal cavity is achieved through one of the natural orifices of the body. Based on experience from gynaecology, transvaginal access has been the easiest NOTES technique to implement in clinical practice. As was the case with laparoscopy, transvaginal NOTES has primarily been evaluated for cholecystectomy. Although the evidence is limited, the data support a safety profile comparable to that of laparoscopy. As for potential benefits, further research needs to be conducted.

Gastrotomy Healing After Transgastric Peritoneoscopy: A Randomized Study in a Pig Model.

INTRODUCTION: Reliable closure and infection prevention are the main barriers for implementation of pure transgastric peritoneoscopy. The primary aim of this study was to assess healing of over the scope clip (OTSC) closed gastrotomies. MATERIALS AND METHODS: Pure transgastric peritoneoscopy was performed in 7 pigs. The pigs were randomized to 14 or 28 postoperative days (POD) of follow-up. Decontamination of the access route was performed before instrumentation. A full necropsy was performed. Closure was evaluated with histopathological examination of excised gastrorrhaphies. RESULTS: Three pigs were allowed 14 POD of follow-up, and 4 pigs were allowed 28 POD of follow-up. Survival was achieved in 6 of the 7 animals; 1 pig was euthanized due to diffuse peritonitis. Based on our definition, full-thickness healing had only been achieved in a single pig allowed 28 POD. With respect to clinical relevancy, full-thickness healing was deemed achieved in 4 of 6 pigs completing follow-up and in all pigs allowed and surviving 28 POD. Access required repeated punctures and the use of several endoscopic instruments. CONCLUSIONS: Full-thickness healing of the gastrotomy was only found in a single case when adhering to the per protocol definition. Endoscopic ultrasonography-guided access was difficult. It lacks reproducibility and needs refinement. Despite a combined decontamination regimen, infectious complications still occurred.

Endoscopic submucosal dissection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

UNLABELLED: This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system 1 2 was adopted to define the strength of recommendations and the quality of evidence. MAIN RECOMMENDATIONS: 1 ESGE recommends endoscopic en bloc resection for superficial esophageal squamous cell cancers (SCCs), excluding those with obvious submucosal involvement (strong recommendation, moderate quality evidence). Endoscopic mucosal resection (EMR) may be considered in such lesions when they are smaller than 10 mm if en bloc resection can be assured. However, ESGE recommends endoscopic submucosal dissection (ESD) as the first option, mainly to provide an en bloc resection with accurate pathology staging and to avoid missing important histological features (strong recommendation, moderate quality evidence). 2 ESGE recommends endoscopic resection with a curative intent for visible lesions in Barrett's esophagus (strong recommendation, moderate quality evidence). ESD has not been shown to be superior to EMR for excision of mucosal cancer, and for that reason EMR should be preferred. ESD may be considered in selected cases, such as lesions larger than 15 mm, poorly lifting tumors, and lesions at risk for submucosal invasion (strong recommendation, moderate quality evidence). 3 ESGE recommends endoscopic resection for the treatment of gastric superficial neoplastic lesions that possess a very low risk of lymph node metastasis (strong recommendation, high quality evidence). EMR is an acceptable option for lesions smaller than 10 - 15 mm with a very low probability of advanced histology (Paris 0-IIa). However, ESGE recommends ESD as treatment of choice for most gastric superficial neoplastic lesions (strong recommendation, moderate quality evidence). 4 ESGE states that the majority of colonic and rectal superficial lesions can be effectively removed in a curative way by standard polypectomy and/or by EMR (strong recommendation, moderate quality evidence). ESD can be considered for removal of colonic and rectal lesions with high suspicion of limited submucosal invasion that is based on two main criteria of depressed morphology and irregular or nongranular surface pattern, particularly if the lesions are larger than 20 mm; or ESD can be considered for colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques (strong recommendation, moderate quality evidence).

Colonoscopy surveillance for dysplasia and colorectal cancer in patients with inflammatory bowel disease.

The risk of colorectal cancer (CRC) and dysplasia in patients with inflammatory bowel disease (IBD) has been highly debated as risk estimates from different studies vary greatly. The present national Danish guideline on colonoscopy surveillance for dysplasia and colorectal cancer in patients with IBD is based on a thorough review of existing literature with particular focus on recent studies from Denmark revealing a lower risk of CRC than previously assumed. The overall risk of CRC in the Danish IBD population does not appear to be different from that of the background population; however, in some subgroups of patients the risk is increased. These subgroups of patients, who should be offered colonoscopy surveillance, include patients with ulcerative colitis having extensive disease and a long disease duration (10-13 years); early age at onset (less than 19 years of age) of ulcerative colitis; and patients with ulcerative colitis as well as Crohn's disease with a concomitant diagnosis of primary sclerosing cholangitis. A colonoscopy surveillance program is recommended in these subgroups with intervals ranging from every 3-6 months to every 5 years, using chromoendoscopy with targeted biopsies of the lesion and adjacent mucosa, instead of conventional colonoscopy with random biopsies. Preferably, the colonoscopy should be performed during clinical remission. If a lesion is detected the endoscopical resectability together with the pathology of the lesion and the adjacent mucosa determine how the lesion should be treated.

Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline.

This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). This Guideline was also reviewed and endorsed by the Governing Board of the American Society for Gastrointestinal Endoscopy (ASGE). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system was adopted to define the strength of recommendations and the quality of evidence. Main recommendations The following recommendations should only be applied after a thorough diagnostic evaluation including a contrast-enhanced computed tomography (CT) scan. 1 Prophylactic colonic stent placement is not recommended. Colonic stenting should be reserved for patients with clinical symptoms and imaging evidence of malignant large-bowel obstruction, without signs of perforation (strong recommendation, low quality evidence). 2 Colonic self-expandable metal stent (SEMS) placement as a bridge to elective surgery is not recommended as a standard treatment of symptomatic left-sided malignant colonic obstruction (strong recommendation, high quality evidence). 3 For patients with potentially curable but obstructing left-sided colonic cancer, stent placement may be considered as an alternative to emergency surgery in those who have an increased risk of postoperative mortality, I. e. American Society of Anesthesiologists (ASA) Physical Status ≥ III and/or age > 70 years (weak recommendation, low quality evidence). 4 SEMS placement is recommended as the preferred treatment for palliation of malignant colonic obstruction (strong recommendation, high quality evidence), except in patients treated or considered for treatment with antiangiogenic drugs (e. g. bevacizumab) (strong recommendation, low quality evidence).

Sexual function after transvaginal cholecystectomy: a systematic review.

INTRODUCTION: Despite several benefits, patients are concerned that transvaginal cholecystectomy has a negative impact on sexual health. The objective of this systematic review was to assess the impact of transvaginal cholecystectomy on postoperative dyspareunia and sexual function. METHOD: A literature search was performed in the PubMed and EMBASE databases. Papers reporting on postoperative dyspareunia, vaginal pain or discomfort, and sexual function were included. RESULTS: Seventeen papers reported on dyspareunia and vaginal pain or discomfort. Two papers reported a rate of de novo dyspareunia of 3.8% and 12.5%, respectively. One study reported a nonsignificant reduction in painful sexual intercourse and the remaining 14 reported no incidents of dyspareunia. Eight papers reported on sexual function. One paper using a nonvalidated questionnaire found impaired sexual function. The papers that used validated questionnaires found no impairment of sexual function. CONCLUSIONS: The risk of sexual dysfunction and dyspareunia after transvaginal cholecystectomy seems minimal. Well-designed studies using validated questionnaires are necessary to fully assess these types of complications.

Diagnosis and management of iatrogenic endoscopic perforations: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

This Position Paper is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). It addresses the diagnosis and management of iatrogenic perforation occurring during diagnostic or therapeutic digestive endoscopic procedures. Main recommendations 1 ESGE recommends that each center implements a written policy regarding the management of iatrogenic perforation, including the definition of procedures that carry a high risk of this complication. This policy should be shared with the radiologists and surgeons at each center. 2 In the case of an endoscopically identified perforation, ESGE recommends that the endoscopist reports: its size and location with a picture; endoscopic treatment that might have been possible; whether carbon dioxide or air was used for insufflation; and the standard report information. 3 ESGE recommends that symptoms or signs suggestive of iatrogenic perforation after an endoscopic procedure should be carefully evaluated and documented, possibly with a computed tomography (CT) scan, in order to prevent any diagnostic delay. 4 ESGE recommends that endoscopic closure should be considered depending on the type of perforation, its size, and the endoscopist expertise available at the center. A switch to carbon dioxide insufflation, the diversion of luminal content, and decompression of tension pneumoperitoneum or tension pneumothorax should also be done. 5 After closure of an iatrogenic perforation using an endoscopic method, ESGE recommends that further management should be based on the estimated success of the endoscopic closure and on the general clinical condition of the patient. In the case of no or failed endoscopic closure of the iatrogenic perforation, and in patients whose clinical condition is deteriorating, hospitalization and surgical consultation are recommended.

Characterisation of oral and i.v. glucose handling in truncally vagotomised subjects with pyloroplasty.

OBJECTIVE: Glucagon-like peptide 1 (GLP1) is rapidly inactivated by dipeptidyl peptidase 4 (DPP4), but may interact with vagal neurons at its site of secretion. We investigated the role of vagal innervation for handling of oral and i.v. glucose. DESIGN AND METHODS: Truncally vagotomised subjects (n=16) and matched controls (n=10) underwent 50 g-oral glucose tolerance test (OGTT)±vildagliptin, a DPP4 inhibitor (DPP4i) and isoglycaemic i.v. glucose infusion (IIGI), copying the OGTT without DPP4i. RESULTS: Isoglycaemia was obtained with 25±2 g glucose in vagotomised subjects and 18±2 g in controls (P<0.03); thus, gastrointestinal-mediated glucose disposal (GIGD) - a measure of glucose handling (100%×(glucoseOGTT-glucoseIIGI/glucoseOGTT)) - was reduced in the vagotomised compared with the control group. Peak intact GLP1 concentrations were higher in the vagotomised group. Gastric emptying was faster in vagotomised subjects after OGTT and was unaffected by DPP4i. The early glucose-dependent insulinotropic polypeptide response was higher in vagotomised subjects. Despite this, the incretin effect was equal in both groups. DPP4i enhanced insulin secretion in controls, but had no effect in the vagotomised subjects. Controls suppressed glucagon concentrations similarly, irrespective of the route of glucose administration, whereas vagotomised subjects showed suppression only during IIGI and exhibited hyperglucagonaemia following OGTT. DPP4i further suppressed glucagon secretion in controls and tended to normalise glucagon responses in vagotomised subjects. CONCLUSIONS: GIGD is diminished, but the incretin effect is unaffected in vagotomised subjects despite higher GLP1 levels. This, together with the small effect of DPP4i, is compatible with the notion that part of the physiological effects of GLP1 involves vagal transmission.

Oral chlorhexidine and microbial contamination during endoscopy: possible implications for transgastric surgery. A randomized, clinical trial.

BACKGROUND: One of the biggest concerns associated with transgastric surgery is contamination and risk of intra-abdominal infection with microbes introduced from the access route. The purpose of this study was to evaluate the effect of oral decontamination with chlorhexidine on microbial contamination of the endoscope. METHODS: In a prospective, randomized, single-blinded, clinical trial the effect of chlorhexidine mouth rinse was evaluated. As a surrogate for the risk of intra-abdominal contamination during transgastric surgery, microbial contamination of the endoscope during upper endoscopy was examined. Patients referred to upper endoscopy were assessed for eligibility and randomized to either chlorhexidine or no mouth rinse. Culture samples were collected from gastric aspirates and endoscopes. The primary outcome measure was colony forming units (CFU) in the endoscope samples. Secondary outcome measures were species specific effect of chlorhexidine on micro-organisms with abscess forming capabilities and the effect of proton pump inhibitor (PPI) treatment on CFU. RESULTS: Chlorhexidine mouth rinse resulted in a significant reduction of CFU in the endoscope samples (p = 0.001). There was no species specific effect and micro-organisms with abscess forming capabilities were equally present. PPI treatment was associated with significantly higher CFU counts in both the gastric (p = 0.004) and endoscope samples (p = 0.049). CONCLUSIONS: Chlorhexidine mouth rinse was effective in reducing microbial contamination of the endoscope, but micro-organisms with abscess forming capabilities were still present. PPI treatment significantly increased CFU and should be discontinued before transgastric surgery.

Self-Expanding Metal Stenting for Palliation of Patients with Malignant Colonic Obstruction: Effectiveness and Efficacy on 255 Patients with 12-Month's Follow-up.

Background. Self-expanding metal stents can alleviate malignant colonic obstruction in incurable patients and avoid palliative stoma surgery. Objective. Evaluate stent effectiveness and safety on palliation of patients with malignant colorectal strictures. Design. Two prospective, one Spanish and one global, multicenter studies. Settings. 39 centers (22 academic, 17 community hospitals) from 13 countries. Patients. A total of 257 patients were enrolled, and 255 patients were treated with a WallFlex uncovered enteral colonic stent. Follow-up was up to 12 months or until death or retreatment. Interventions(s). Self-expanding metal stent placement. Main Outcome Measures. Procedural success, clinical success, and safety. Results. Procedural success was 98.4% (251). Clinical success rates were 87.8% at 30 days, 89.7% at 3 months, 92.8% at 6 months, and 96% at 12 months. Overall perforation rate was 5.1%. Overall migration rate was 5.5%. Overall death rate during follow-up was 48.6% (124), with 67.7% of deaths related to the patient's colorectal cancer, unrelated in 32.3%. Only 2 deaths were related to the stent or procedure. Limitations. No control group. Conclusions. The primary palliative option for patients with malignant colonic obstruction should be self-expanding metal stent placement due to high rates of technical success and efficacy in symptom palliation and few complications.

Pure natural orifice transluminal endoscopic surgery (NOTES) with ultrasonography-guided transgastric access and over-the-scope-clip closure: a porcine feasibility and survival study.

BACKGROUND: Most natural orifice transluminal endoscopic surgery (NOTES) procedures to date rely on the hybrid technique with simultaneous laparoscopic access to protect against access-related complications and to achieve adequate triangulation for dissection. This is done at the cost of the potential benefits of this new minimally invasive technique. This study aimed to evaluate the feasibility and safety of a transgastric (TG) pure-NOTES procedure in a diagnostic setting. METHODS: A TG pure-NOTES procedure with endoscopic ultrasonograpy (EUS)-guided access and over-the-scope-clip (OTSC) closure was performed for 10 pigs in a survival and feasibility study. A full macroscopic necropsy with subsequent histologic evaluation was performed on postoperative day (POD) 14. The outcome parameters were uncomplicated follow-up assessment, survival, intraoperative complications, intraabdominal pathology, macroscopic full-thickness closure, and histology-proven full-thickness healing of the gastrotomy. RESULTS: An uncomplicated postoperative course was reported for 9 of the 10 pigs, and survival was reported for all 10 pigs. For all the pigs, EUS-guided access was performed successfully with a median duration of 25 min (range, 12-62 min) and without intraoperative complications or access-related lesions at necropsy. An OTSC closure was achieved with a median duration of 11 min (range, 3-28 min). The OTSC provided immediate closure, but according to the authors' definition of a full-thickness healing evaluated by histologic examination, this was not achieved in any of the cases. Although all the animals survived until POD 14, intraabdominal chronic abscesses were present in 3 of the 10 pigs at necropsy. CONCLUSIONS: The EUS-guided TG access proved to be feasible without access-related complications. Although OTSC provided an immediate closure, the histopathology raised concerns regarding the risk of perforation. Together with the high risk of intraabdominal infection, TG pure-NOTES is not yet ready for routine clinical practice.

Transgastric pure-NOTES peritoneoscopy and endoscopic ultrasonography for staging of gastrointestinal cancers: a survival and feasibility study.

BACKGROUND: Human natural orifice transluminal endoscopic surgery (NOTES) has mainly been based on simultaneous laparoscopic assistance (hybrid NOTES), forgoing the theoretical benefits of the NOTES technique. This is due to a lack of NOTES-specific instruments and endoscopes, making pure-NOTES procedures difficult and time consuming. An area where pure NOTES could be adopted at its present stage of development is minimally invasive staging of gastrointestinal (GI) cancer. The aim of this study is to evaluate the feasibility of combining transgastric (TG) pure-NOTES peritoneoscopy and intraperitoneal endoscopic ultrasonography (ip-EUS) with intraluminal EUS (il-EUS) for peritoneal evaluation. METHODS: This was a feasibility and survival study where il-EUS followed by ip-EUS and peritoneoscopy was performed in 10 pigs subjected to TG pure NOTES. A score was given with regard to achieved visualisation of predefined anatomical structures. Survival was assessed at postoperative day (POD) 14. RESULTS: All animals survived until POD 14. Median total procedural time was 94 min (range 74-130 min). Median time for il-EUS, ip-EUS and peritoneoscopy was 11 min (range 7-14 min), 13 min (range 8-20 min) and 10 min (range 6-23 min). Il-EUS, ip-EUS and peritoneoscopy resulted in a score of 15/15 points (range 14-15 points), 6/9 points (range 1-8 points) and 12/13 points (range 8-13 points). CONCLUSIONS: TG pure-NOTES peritoneoscopy and ip-EUS combined with il-EUS is feasible and provides sufficient peritoneal evaluation. The technique could have potential for minimally invasive staging of GI cancers.

Self-expandable metal stents for relieving malignant colorectal obstruction: short-term safety and efficacy within 30 days of stent procedure in 447 patients.

BACKGROUND: The self-expandable metal stent (SEMS) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery. OBJECTIVE: To document performance, safety, and effectiveness of colorectal stents used per local standards of practice in patients with malignant large-bowel obstruction to avoid palliative stoma surgery in incurable patients (PAL) and facilitate bowel decompression as a bridge to surgery for curable patients (BTS). DESIGN: Prospective clinical cohort study. SETTING: Two global registries with 39 academic and community centers. PATIENTS: This study involved 447 patients with malignant colonic obstruction who received stents (255 PAL, 182 BTS, 10 no indication specified). INTERVENTION: Colorectal through-the-scope SEMS placement. MAIN OUTCOME MEASUREMENTS: The primary endpoint was clinical success at 30 days, defined as the patient's ability to maintain bowel function without adverse events related to the procedure or stent. Secondary endpoints were procedural success, defined as successful stent placement in the correct position, symptoms of persistent or recurrent colonic obstruction, and complications. RESULTS: The procedural success rate was 94.8% (439/463), and the clinical success rates were 90.5% (313/346) as assessed on a per protocol basis and 71.6% (313/437) as assessed on an intent-to-treat basis. Complications included 15 (3.9%) perforations, 3 resulting in death, 7 (1.8%) migrations, 7 (1.8%) cases of pain, and 2 (0.5%) cases of bleeding. LIMITATIONS: No control group. No primary endpoint analysis data for 25% of patients. CONCLUSION: This largest multicenter, prospective study of colonic SEMS placement demonstrates that colonic SEMSs are safe and highly effective for the short-term treatment of malignant colorectal obstruction, allowing most curable patients to have 1-step resection without stoma and providing most incurable patients minimally invasive palliation instead of surgery. The risk of complications, including perforation, was low.

Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos).

BACKGROUND: The feasibility of single-operator cholangioscopy (SOC) for biliary diagnostic and therapeutic procedures was previously reported. OBJECTIVE: To confirm the utility of SOC in more widespread clinical use. DESIGN: Prospective clinical cohort study. SETTING: Fifteen endoscopy referral centers in the United States and Europe. PATIENTS: Two hundred ninety-seven patients requiring evaluation of bile duct disease or biliary stone therapy. INTERVENTIONS: SOC examination and, as indicated, SOC-directed stone therapy or forceps biopsy. MAIN OUTCOME MEASUREMENTS: Procedural success defined as ability to (1) visualize target lesions and, if indicated, collect biopsy specimens adequate for histological evaluation or (2) visualize biliary stones and initiate fragmentation and removal. RESULTS: The overall procedure success rate was 89% (95% CI, 84%-92%). Adequate tissue for histological examination was secured in 88% of 140 patients who underwent biopsy. Overall sensitivity in diagnosing malignancy was 78% for SOC visual impression and 49% for SOC-directed biopsy. Sensitivity was higher (84% and 66%, respectively) for intrinsic bile duct malignancies. Diagnostic SOC procedures altered clinical management in 64% of patients. Procedure success was achieved in 92% of 66 patients with stones and complete stone clearance during the study SOC session in 71%. The incidence of serious procedure-related adverse events was 7.5% for diagnostic SOC and 6.1% for SOC-directed stone therapy. LIMITATIONS: The study was observational in design with no control group. CONCLUSIONS: Evaluation of bile duct disease and biliary stone therapy can be safely performed with a high success rate by using the SOC system.

[Natural Orifice Transluminal Endoscopic Surgery--the next step in minimal invasive surgery]. / NOTES-kirurgi er det naeste udviklingstrin inden for minimalt invasiv kirurgi.

Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a recently introduced minimal invasive surgical technique using the natural openings of the human body. The Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) has identified a number of areas that require further investigation before NOTES can be implemented in daily clinical practice. The past years have shown extensive progress within research and development of NOTES, but randomized controlled trials are still lacking. These are essential to determine whether NOTES will benefit patients and the health care sector in general.