Endoscopic trans-anal tube placement is a safe and helpful tool for colonic decompression: final results of a standardized single-centre retrospective assessment of 125 patients.

OBJECTIVES: Endoscopic trans-anal colonic decompression (ECD) may be requested in the case of massive colon distension, but evidence regarding success and safety issues remains scarce. The aim of this analysis is to examine the technical success, complications and clinical outcome in a large series of patients undergoing an ECD in various clinical scenarios. A standardized evaluation system was used to identify the pre-interventional risk parameters that might be helpful to guide clinical decision making. METHODS: In this single-centre retrospective study, the modified Clavien-Dindo classification (CDC) was applied to assess technical success, complications and clinical outcome of 125 consecutive patients who underwent ECD between 2007 and 2020. PRIMARY ENDPOINT: post interventional 90-day mortality. Secondary endpoints: periprocedural complications (CDC event IV-V) and technical success rate. All Martin criteria for standardized reporting of complications were met. Uni- and multivariable analyses for prediction of complications were carried out. RESULTS: The overall technical success rate was 90%. The periprocedural complication rate was low with 3%. Overall 90-day mortality was 31%. Univariable analyses showed a significant correlation between 90-day mortality and ASA≥4 (p<0.001, odds ratio [OR] 15.33), general anaesthesia (p=0.05, OR 21.42) and elevated serological infection parameters (p 0.028, OR 1.004). The pre-interventional multivariable model identified ASA ≥4 (p <0.001; OR 10.94) as the only independent risk factor. CONCLUSIONS: ECD is a safe, easily available, technical feasible, inexpensive and successful tool for colonic decompression in various colonic obstruction scenarios, even in critically ill patients. ASA Score ≥IV can be helpful to identify patients at risk for complications/mortality after ECD.

Telemetric capsule-based upper gastrointestinal tract - blood detection - first multicentric experience.

INTRODUCTION: Risk stratification in upper gastrointestinal bleeding (UGIB) currently relies on clinical parameters and risk scores. HemoPill® acute (Ovesco Endoscopy, Tuebingen, Germany) is a pill-shaped, orally administered sensor capsule for real-time blood detection. The aim of this study was to evaluate the system in clinical routine. MATERIAL AND METHODS: Sixty-one consecutive patients in whom the HemoPill® had been used at 12 international hospitals between July 2019 and March 2020 were retrospectively analysed. Indications for application were the clinical suspicion of UGIB, small bowel bleeding, of rebleeding after hemostasis. Primary endpoints were technical success and bleeding detection/exclusion. Secondary endpoints included adverse events and change of clinical course. RESULTS: The capsule was used in 45 (73%) patients with UGIB, in 12 (20%) patients with small bowel bleeding and in four (7%) patients for exclusion of rebleeding. Technical success was 98%. 35/60 (58%) cases were capsule-positive and among these, endoscopy showed bleeding in 20/35 (57%) cases. None of the 25 capsule-negative patients rebled. Emergency endoscopy could be avoided in 18/25 (72%) cases. Serious adverse events did not occur. CONCLUSION: HemoPill®-based blood detection is feasible and safe. Negative capsule results might 'downgrade' the need for urgent endoscopy.

Efficacy of the OTSC System in the treatment of GI bleeding and wall defects: a PMCF meta-analysis.

Since its market launch in 2007, the endoscopic OTSC clipping system has been the object of intensive clinical research. These data were systematically collected for post-market clinical follow-up (PMCF). The aim of the study was the systematic review of the efficacy and safety of the OTSC System. The PMCF database was systematically searched for clinical data on OTSC therapy of GI hemorrhage (H), acute leaks/perforations (AL) and chronic leaks/fistulae (CL). Major outcomes were successful clip application and durable hemostasis/closure of defects. Comprehensive pooled success proportions were established by meta-analytical methods. Four-hundred-fifty-seven publications were reviewed. Fifty-eight articles comprising 1868 patients fulfilled criteria to be included in the analysis. These consisted of retrospective analyses, prospective observational trials, one randomized-controlled trial (STING) and one quasi-controlled study (FLETRock). The pooled proportion analysis revealed high overall proportions of technical success: H - mean 93.0% [95%CI 90.2-95.4], AL-mean 89.7% [95%CI 85.9-92.9] and CL-mean 83.8% [95%CI 76.9-89.7]. Pooled durable clinical success proportions were: H-mean 87.5% [95%CI 80.5-93.2], AL-mean 81.4% [95%CI 77.0-85.3] and CL-mean 63.0% [95%CI 53.0-72.3]. By pooling all clinical data gained, we conclude that OTSC application in GI hemorrhage and closure of GI lesions is safe and effective in real clinical use.

Preclinical evaluation of a novel thermally sensitive co-polymer (LiftUp) for endoscopic resection.

Introduction: Endoscopic resection techniques can successfully resect large lesions either in "en bloc" fashion or in "piece-meal" technique by using a submucosal injection solution. The aim of this study was to evaluate the safety of a novel injectable, containing thermally sensitive co-polymer from ethylenoxide and propylenoxide (LiftUp) used as submucosal injection solution.Material and methods: We conducted an in vivo animal trial in the porcine model to evaluate the LiftUp gel in a preclinical setting and to study the effectiveness of mucosal lifting and the safety of the new injectable. In seven animals a total of 63 injections and endoscopic resections were carried out in different anatomical locations (esophagus, stomach and rectum). The resection sites were controlled endoscopically one and four weeks after resection and a histopathological evaluation of the resection sites was performed after four weeks.Results: The application of LiftUp was safe and there were no negative effects on wound healing after injection and resection. A major procedural complication rate (defined as perforation and major haemorrhage) of 3.2% was registered, which undercuts the anticipated mean complication rate of 4-8%. Furthermore, there was no necessity of reinjection after the initial submucosal injection in 90.5% and no procedural complications in 98.8%. The histopathological examination of the tissue samples indicated normal wound healing with granulation tissue and epithelialisation.Conclusion: The use of LiftUp as submucosal injection solution was feasible for different endoscopic resection techniques, with high and long-lasting elevation and fewer procedural adverse events than expected at trial planning. The new injectable is a practical advancement over the current state-of-the-art of submucosal injection and could fasten up the resection procedure and make endoscopic 'en bloc' resection safer.

Technological review on endoscopic submucosal dissection: available equipment, recent developments and emerging techniques.

Endoscopic submucosal dissection (ESD) is widely practiced in Japan and the Eastern World and is rapidly expanding in western countries for the management of early malignancies of the upper and lower gastrointestinal tube. In addition, novel therapeutic applications deriving from ESD have emerged including the treatment of achalasia, of submucosal tumors, of diverticula, of strictures and of reflux disease. An ESD procedure necessitates not only skills and specific training, but also familiarization with a vast spectrum of devices (endoscopes, high-frequency generators and their settings, endoknives, hoods, irrigation devices) and techniques (such as countertraction, artificial ulcer closure), that render the procedure faster, more efficient and safer. This technological article gives an overview on current and novel equipment for an ESD and associated techniques.

Triluminal hybrid NOS as a novel approach for colonic resection with colorectal anastomosis.

BACKGROUND: Minimal invasive surgery has led to a significant decrease in surgical trauma, pain, recovery time and improved cosmesis compared with open surgery. However, scar development and the risk of hot spots for infections and hernias are still present. Natural orifice surgery (NOS) promises to offer even further reduction in invasiveness and thus may lead to even faster recovery. The goal of this study was to establish a NOS colonic resection by using commercially available standard surgical instruments avoiding major abdominal incisions. METHODS AND RESULTS: This article reports a new triluminal hybrid NOS approach for sigmoid and colonic resection (Tri-Port-NOS-SIG), established using rigid laparoscopic instruments through the umbilicus, the vagina, and the rectum, without any major abdominal incision. The specimen was retrieved through the anus avoiding dilatation of the vagina. In an early series of 5 patients the first patient was a 37-year-old woman with a 10-year history of recurrent diverticulitis. She recovered quickly and was discharged on postoperative day 2. She returned to sports activity on day 12 postoperatively and to her heavy-duty job on day 16. The following 4 patients also recovered well and were discharged on postoperative days 7 (2 patients), 8, and 11, respectively. One patient experienced a temporary, mild paresthesia of the left lower dorsal leg, most likely because of intraoperative positioning. No major complications occurred. CONCLUSION: Tri-Port-NOS-SIG offers a feasible scarless approach for abdominal resections using commercially available surgical instruments in experienced hands.

Use of the over-the-scope-clip (OTSC) in non-variceal upper gastrointestinal bleeding in patients with severe cardiovascular comorbidities: a retrospective study.

INTRODUCTION: The over-the-scope-clip (OTSC) can potentially overcome limitations of standard clips and achieve more efficient and reliable hemostasis. Data on OTSC use for non-variceal upper gastrointestinal bleeding (NVUGIB) in patients with cardiovascular comorbidities are currently limited. PATIENTS AND METHODS: We prospectively collected and retrospectively analyzed our database from February 2009 to September 2015 from all patients who underwent emergency endoscopy for high-risk NVUGIB in 2 academic centers and were treated with OTSC as first-line (n = 81) or second-line therapy (n = 19). RESULTS: One hundred patients mean age 72 (range 27 - 97 years) were included in this study. Fifty-one percent (n = 51) had severe cardiovascular co-morbidity (ischemic heart disease, congestive heart failure, hypertension, valvular heart disease, peripheral arterial occlusive disease and atrial fibrillation) and 73 % (n = 73) were on antiplatelet or/and anticoagulation therapy. The median size of the treated ulcers was 3 cm (range 1 - 5 cm). In 94 % (n = 94) primary hemostasis with OTSC was achieved. Clinical long-term success during a mean 6-month follow-up without rebleeding was 86 % (n = 86). CONCLUSIONS: In this cohort OTSC was demonstrated to be a safe and effective first- or second-line treatment for NVUGIB in high-risk patients with cardiovascular disease and complex, large ulcers.

The complementary Erlangen active simulator for interventional endoscopy training is superior to solely clinical education in endoscopic hemostasis--the French training project: a prospective trial.

BACKGROUND: The Erlangen Active Simulator for Interventional Endoscopy (EASIE) using ex-vivo porcine organs was introduced in 1997. The present study should analyze whether repeated EASIE simulator training in endoscopic hemostasis led to superior performance compared with a traditionally educated group. The results were compared with a similar project in New York. METHODS: Thirty-five French GI fellows were enrolled. Baseline skills evaluation was performed in four disciplines (manual skills, injection/coagulation, clip application and variceal ligation) using the compactEASIE-simulator equipped with an upper gastrointestinal organ package for bleeding simulation. The same, translated evaluation forms (from the prior New York project) were used. Subsequently, fellows were randomized into group A (n=17, only clinical education) and group B (n=18, additional three simulator trainings). Group B was trained the next day and after 4 and 7 months by experts of the French Society of Gastrointestinal Endoscopy. Both groups performed routine and emergency endoscopies at their home hospitals during the study period. Both groups were re-evaluated blindly after 9 months. RESULTS: The learning curve for group B showed a significant improvement in all disciplines (P<0.004) whereas group A improved significantly in only two of four disciplines at blinded final evaluation (manual skills P=0.02, injection/coagulation P=0.013). The direct comparison of groups B and A at blinded final evaluation showed significantly superior ratings for group B in all disciplines (P<0.006) and significantly shorter performance times in two disciplines (P=0.016 each). The comparison with the similar 'New York project' revealed that preexisting differences in skills were adjusted by the training. CONCLUSION: Complementary trainings (three workshops in 7 months) in endoscopic hemostasis using the compactEASIE improved skills compared with a solely clinical education. The results of the 'New York project' were confirmed and benefits were independent from the medical educational system.

Currently available simulators: ex vivo models.

The introduction of the ex vivo tissue endoscopy simulators represents a major advance in endoscopic training, particularly in therapeutic endoscopy. The simulators have been popular teaching tools from the start, and the data supporting their benefit are accruing, especially in hemostasis training. Simulators like the compact EASIE may prove most beneficial as training tools for interventional skills that require repetitive practice and a larger volume of procedures than may occur naturally during the course of standard endoscopy practice. More data are needed to confirm that hands-on simulator training improves outcomes in clinical endoscopic performance and to characterize better the influence of such simulator work on subsequent endoscopic practice. As ex vivo simulators become more available, it is likely that these models will enhance initial training and also allow practicing gastroenterologists to acquire new techniques, maintain their skills, and demonstrate proficiency for credentialing purposes.

One hundred and one over-the-scope-clip applications for severe gastrointestinal bleeding, leaks and fistulas.

AIM: To investigate the efficacy and clinical outcome of patients treated with an over-the-scope-clip (OTSC) system for severe gastrointestinal hemorrhage, perforations and fistulas. METHODS: From 02-2009 to 10-2012, 84 patients were treated with 101 OTSC clips. 41 patients (48.8%) presented with severe upper-gastrointestinal (GI) bleeding, 3 (3.6%) patients with lower-GI bleeding, 7 patients (8.3%) underwent perforation closure, 18 patients (21.4%) had prevention of secondary perforation, 12 patients (14.3%) had control of secondary bleeding after endoscopic mucosal resection or endoscopic submucosal dissection (ESD) and 3 patients (3.6%) had an intervention on a chronic fistula. RESULTS: In 78/84 patients (92.8%), primary treatment with the OTSC was technically successful. Clinical primary success was achieved in 75/84 patients (89.28%). The overall mortality in the study patients was 11/84 (13.1%) and was seen in patients with life-threatening upper GI hemorrhage. There was no mortality in any other treatment group. In detail OTSC application lead to a clinical success in 35/41 (85.36%) patients with upper GI bleeding and in 3/3 patients with lower GI bleeding. Technical success of perforation closure was 100% while clinical success was seen in 4/7 cases (57.14%) due to attendant circumstances unrelated to the OTSC. Technical and clinic success was achieved in 18/18 (100%) patients for the prevention of bleeding or perforation after endoscopic mucosal resection and ESD and in 3/3 cases of fistula closure. Two application-related complications were seen (2%). CONCLUSION: This largest single center experience published so far confirms the value of the OTSC for GI emergencies and complications. Further clinical experience will help to identify optimal indications for its targeted and prophylactic use.

Endoscopic tumor treatment in the bile duct.

There is little information in the literature on endoscopic tumor treatment in the bile duct with a curative intention. This article reports on the few cases published and on the authors' own experience with endoscopic retrograde and percutaneous transhepatic cholangioscopic treatment of tumors in the biliary system.

Training with the compactEASIE biologic endoscopy simulator significantly improves hemostatic technical skill of gastroenterology fellows: a randomized controlled comparison with clinical endoscopy training alone.

BACKGROUND: The Erlangen Active Simulator for Interventional Endoscopy (EASIE) was introduced in 1997 for interventional endoscopy training. compactEASIE developed in 1998 is a modified, light-weight version of the original model. Objective evidence of the benefits of training with these models is limited. A randomized controlled study, therefore, was conducted to compare the effects of intensive 7-month, hands-on training in hemostatic techniques by using the compactEASIE model (in addition to clinical endoscopic training) vs. pure clinical training in endoscopic hemostatic methods. METHODS: Thirty-seven fellows in gastroenterology in New York City area training programs were enrolled. Baseline skills were assessed on the simulator for the following techniques: manual skills, injection and electrocoagulation, hemoclip application, and variceal ligation. Twenty-eight fellows were then randomized into two comparable groups. Those randomized to Group A received purely clinical training in endoscopic hemostatic techniques at their hospitals. Those in Group B, in addition, were trained by experienced tutors in 3 full-day hemostasis workshops over 7 months. Both groups underwent a final evaluation on the compactEASIE simulator conducted by their tutors and additional evaluators who were blinded to the method of training. Initial and final evaluation scores were compared for each group and between groups. Outcomes of actual clinical hemostatic procedures performed during the study period also were analyzed. RESULTS: Ten of 14 fellows randomized to Group A (standard training) and 13 of 14 in Group B (intensive training) returned for the final evaluation. For Group B, scores for all techniques were significantly improved. In Group A, a significant improvement was noted for variceal ligation alone. CONCLUSIONS: compactEASIE simulator training (3 sessions over 7 months), together with clinical endoscopic training resulted in objective improvement in the performance by fellows of all 4 endoscopic hemostatic techniques, whereas significant improvement was noted for variceal ligation alone for fellows who had standard clinical training. In clinical practice, fellows who had intensive simulator/clinical training had a significantly higher success rate and a nonsignificant reduction in the frequency of occurrence of complications.

Efficacy and costs of a one-day hands-on EASIE endoscopy simulator train-the-trainer workshop.

BACKGROUND: The efficacy of an intensive hands-on training in endoscopic hemostasis on the compactEASIE simulator has been previously demonstrated in a randomized prospective trial. In the current study, we evaluated how quickly and effectively new tutors, without simulator training experience, are able to acquire teaching skills in endoscopic hemostasis. METHODS: Five tutors with prior Erlangen Active Simulator for Interventional Endoscopy (EASIE) teaching experience instructed 7 endoscopists without prior EASIE experience on how to teach when using the model. These new tutors then independently conducted a workshop for 8 fellows in 4 hemostasis techniques. Results were compared with a historical control trained similarly by experienced tutors. Two one-day workshops in endoscopic hemostasis on the compactEASIE ex vivo endoscopy simulator were conducted in a category A hospital in New York City, New York. Skill scores at the end of training were compared with baseline skills assessments, and qualitative ratings of the new tutors were obtained from both the trainees and the experienced tutors. RESULTS: Significant improvement was achieved by the fellows in all 4 skills areas. Both the expert tutors and the trainees consistently rated the teaching skill of the new tutors highly. Fellows' skill acquisition using new tutors was of similar magnitude to that achieved in the prior EASIE trial using experienced trainers teaching the fellows. CONCLUSIONS: It is feasible to conduct an effective EASIE train-the-trainer course in one day. Tutors trained in this manner are able to provide a similar educational experience with objective improvement in trainee skill to experts who have conducted many hands-on workshops.

Complications of endoscopic sphincterotomy: can heparin prevent acute pancreatitis after ERCP?

BACKGROUND: An exploratory analysis of a prospective study of risk factors for acute pancreatitis after ERCP combined with endoscopic sphincterotomy showed that the frequency of acute pancreatitis was lower in patients who received heparin compared with patients not treated with heparin. The study was continued to further analyze the effect of heparin on the frequency of acute pancreatitis. METHODS: Potential risk factors for acute pancreatitis and outcomes were evaluated prospectively for all ERCP procedures with endoscopic sphincterotomy performed between September 1994 and December 1998. The results were analyzed by univariate and multivariate methods to determine risk factors for complications. Heparin was administered to 32.9% of the patients (heparin group [HEP group], n = 268) for various clinical reasons (low-molecular-weight heparin, n = 208, unfractionated heparin n = 60). A group of 547 patients who did not receive heparin served as control patients (CON group). RESULTS: Eight hundred fifteen patients underwent ERCP with endoscopic sphincterotomy; acute pancreatitis occurred in 6.4% (n = 52). The frequency of acute pancreatitis was significantly lower in the HEP group versus the CON group in the final multivariate model, which included significant risk factors for acute pancreatitis (HEP group: 3.4%, 9/268 vs. CON group: 7.9%, 43/547; p = 0.005). HEP did not increase the risk of hemorrhage (HEP group: 1.1%, 3/268, 2 severe, none fatal vs. CON group: 2.0%, 11/547, 3 severe, 2 fatal). HEP (p = 0.005; OR 0.3: 95% CI [0.16, 0.73]) and the number of risk factors present (p = 0.0001; OR 2.5: 95% CI [1.80, 3.50]) influenced the frequency of acute pancreatitis independently. CONCLUSIONS: Heparin was significantly associated with an extremely low frequency of post-ERCP pancreatitis without increasing the risk of hemorrhage after endoscopic sphincterotomy. Because this effect could not be attributed to other known or suspected confounders, our conclusion was that heparin administration before ERCP reduces the risk of pancreatitis.