Prophylactic clipping using the over-the-scope clip (OTSC) system after complex ESD and EMR of large colon polyps.

BACKGROUND: Delayed bleeding is the most frequent complication after endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) of large colon polyps. Today, prophylactic clipping with through-the-scope clips (TTSCs) is commonly used to reduce the risk of bleeding. However, the over-the-scope clip (OTSC) system might be superior to TTSCs in achieving hemostasis. This study aims to evaluate the efficacy and safety of prophylactic clipping using the OTSC system after ESD or EMR of large colon polyps. METHODS: This is a retrospective analysis of a prospective collected database from 2009 until 2021 of three endoscopic centers. Patients with large (≥ 20 mm) colon polyps were enrolled. All polyps were removed by either ESD or EMR. After the resection, OTSCs were prophylactically applied on parts of the mucosal defect with a high risk of delayed bleeding or/and perforation. The main outcome measurement was delayed bleeding. RESULTS: A total of 75 patients underwent ESD (67%, 50/75) or EMR (33%, 25/75) in the colorectum. The mean resected specimen diameter was 57 mm ± 24.1 (range 22-98 mm). The mean number of OTSCs placed on the mucosal defect was 2 (range 1-5). None of the mucosal defects were completely closed. Intraprocedural bleeding occurred in 5.3% (ESD 2.0% vs. EMR 12.0%; P = 0.105), and intraprocedural perforation occurred in 6.7% (ESD 8% vs. EMR 4%; P = 0.659) of the patients. Hemostasis was achieved in 100% of cases of intraprocedural bleeding, whereas two patients required surgical conversion due to intraprocedural perforation. Among the remaining 73 patients who received prosphylactic clipping, delayed bleeding occurred in 1.4% (ESD 0% vs. EMR 4.2%; P = 0.329), and delayed perforation occurred in 0%. CONCLUSIONS: The prophylactic partial closure of large post-ESD/EMR mucosal defects using OTSCs could serve as an effective strategy to reduce the risk of delayed bleeding and perforation. The prophylactic partial closure of large complex post-ESD/EMR mucosal defects using OTSCs could serve as an effective strategy to reduce the risk of delayed bleeding and perforation.

Endoscopic submucosal dissection with a novel high viscosity injection solution (LiftUp) in an ex vivo model: a prospective randomized study.

Introduction Endoscopic submucosal dissection (ESD) is increasingly being used in the western world. Submucosal injectates are an essential tool for the ESD procedure. In this study, we evaluated a novel copolymer injectate (LiftUp, Ovesco, Tübingen Germany) in an established ESD model (EASIE-R) in comparison to existing submucosal injectables. Materials and methods We conducted a prospective, randomized ex vivo study performing ESD with three injectates: LiftUp, hydroxyethyl starch (HAES 6 %) and normal saline solution (NaCl 0.9 %). A total of 60 artificial lesions, each 3 × 3 cm in size, were resected in an ex vivo porcine model, utilizing one of the three studied injectates (n = 20 ESDs per injectate). Study parameters were: en bloc resection rate, perforation rate, lifting property, time of injection, injectate volume, general ESD procedure time, and overall procedure time. Results All 60 lesions were successfully resected using the standard ESD technique. LiftUp had no procedure related perforations, one perforation occurred in the HAES group, and two perforations in the NaCl group ( P  > 0.05). Furthermore, adequate lifting was achieved in 16/20 (80 %) using LiftUp, 6/20 (30 %) in the HAES group and 6/20 (30 %) in the NaCl group ( P  < 0.0002). En bloc resection was achieved in 19 (95 %) with LiftUp, in 20 (100 %) with HAES, and in 16 (80 %) with NaCl. General ESD procedure time and overall procedure time were not different among the three groups. Conclusion LiftUp appears to be a safe alternative to established fluids for ESD. It had a significantly improved lifting effect and required significantly less injected volume compared to well-established lifting solutions.

Multicenter evaluation of first-line endoscopic treatment with the OTSC in acute non-variceal upper gastrointestinal bleeding and comparison with the Rockall cohort: the FLETRock study.

INTRODUCTION: The over-the-scope clip (OTSC) overcomes limitations of standard clips and achieves a more efficient and reliable hemostasis in non-variceal upper gastrointestinal bleeding (NVUGIB). The study aims to evaluate mortality, rebleeding, and mortality after rebleeding of patients in whom the OTSC was used as the first-line endoscopic treatment (FLET) of NVUGIB. PATIENTS AND METHODS: In total, 118 patients (FLET cohort) with a median age of 73.5 years (range 29-93 years; mean (±SD) 71.39 ± 12.39 years) were included. The distribution of patients with respect to risk category revealed a median Rockall score of 7 (range 3-10). For hypothesis testing, the FLET cohort was categorized into three risk groups taking into account the Rockall score: low risk [Rockall risk category (RRC ≤3)], moderate risk (RRC 4-7), and high risk (RRC ≥8). Event rates (mortality, rebleeding, and mortality after rebleeding) observed per risk group were compared to predicted event rates (Rockall cohort) using Fisher's Exact Test. RESULTS: Primary successful hemostasis (PSH) was achieved in 92.4% either by FLET alone or in combination with an additional hemostasis technique in 1.7% (SCS = secondary clinical success). In 7.5% of the FLET cohort PSH could not be achieved. Compared to RRC prediction, mortality after rebleeding was significantly reduced from 27.9 to 10.9% in the high-risk group (RRC ≥8) treated with FLET (p < 0.011). Furthermore, the occurrence of rebleeding or continued bleeding was significantly lower in the moderate risk group (RRC 4-7) with 4.9% as well as in the high-risk group (RRC ≥8) with 21.4% compared to the Rockall cohort 24.0 and 53.2%, respectively (p < 0.001). CONCLUSIONS: This study shows that OTSC is superior to standard care and FLET reduces significantly rebleeding and rebleeding-associated mortality in NVUGIB. For this reason, OTSC could be the treatment of choice as the first-line treatment as an alternative to standard hemostasis techniques in high-risk patients.

[Endoscopic submucosal dissection]. / Endoskopische Submukosadissektion.

Endoscopic submucosal dissection (ESD) was developed in Japan but has now also become permanently established in various centers in Europe. ESD is an endoscopic en bloc mucosal resection technique for the treatment of early cancers with a diameter >1 cm and also superficial precancerous lesions, which could only be removed unsatisfactorily in several fragments or with uncertain lateral safety margins using previous loop excision procedures. Using ESD a lesion is excised after circular marking and generous submucosal injection with a safety margin of approximately 5 mm and subsequently resected at the level of the submucosa with a 1-3 mm short diathermic knife. ESD requires high technical skills in interventional endoscopy and is more time-consuming than snare resection techniques. However, numerous studies have shown a clear superiority for ESD with respect to the R0 resection rate and the local recurrence rate. The present article gives a current review of the use of ESD in the upper and lower gastrointestinal tract and demonstrates perspectives of the procedure.

[Diagnostic and interventional endoscopy in gastroenterology : from high-resolution chips and procedures for endoscopic resection to NOTES]. / Diagnostische und interventionelle Endoskopie in der Gastroenterologie : Von "High-resolution-Chips" über endoskopische Resektionsverfahren zu NOTES.

In the past 10 years endoscopic diagnostics has benefited from technologies such as big chips, high-definition television (HDTV) and narrow band imaging (NBI). Video capsule endoscopy and double balloon enteroscopy have facilitated visualization of the entire small bowel. A number of studies on mucosal Barrett's and gastric cancers could prove that endoscopic mucosal resection (EMR) is oncologically equivalent to surgical resection when certain criteria are respected. However, EMR is less invasive and carries a substantially lower complication risk and mortality compared to surgery. Endoscopic submucosal dissection (ESD) facilitates en bloc resection with thorough histopathologic evaluation of the specimen, e.g. for mucosal lesions in the stomach and rectum. Endosonography (EUS) guided transgastric necrosectomy using a flexible gastroscope has set a milestone in the treatment of infected pancreatic necroses and has replaced open surgery in many centers. Natural orifice transluminal endoscopic surgery (NOTES) uses natural body openings as minimally invasive access to the abdomen and mediastinum. Interventional GI endoscopists and minimally invasive surgeons have profited from these innovations in micromechanics and microelectronics.

[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.

A novel model for training in ERCP with double-balloon enteroscopy after abdominal surgery.

BACKGROUND: Since the first presentation of the compactEASIE in 1997, this training model has become established for nearly all interventional techniques in upper gastrointestinal endoscopy including ERCP. So far, training using double-balloon enteroscopy (DBE) for ERCP has not become established. AIMS: This paper presents a special organ preparation for the compactEASIE model which for the first time allows simulation of ERCP in patients who have had prior abdominal surgery. Two abdominal organ packages from freshly slaughtered pigs were used to create a postsurgical anatomic situation. RESULTS: A life-like training model was established for ERCP training in a postsurgical anatomic situation. A Roux-en-Y anastomosis was created such that the papilla was located around 100 cm beyond the pylorus. The duodenum was closed shortly above the pig papilla at the level of the pylorus. The papilla was successfully reached by DBE after 40 minutes. The papilla was cannulated and regular contrasting of the biliary system using fluoroscopy was achieved. Sphincterotomy, stent placement and exchange, and needle-knife sphincterotomy over a 7-Fr stent were conducted successfully. CONCLUSION: Modified organ preparations allow the simulation of and training in ERCP in postsurgical anatomic situations in training models using animal parts.

The compactEASIE is a feasible training model for endoscopic novices: a prospective randomised trial.

BACKGROUND: The objective benefit of a training using the compact Erlangen Active Simulator for Interventional Endoscopy-simulator was demonstrated in two prospective educational trials (New York, France). The present study analysed whether endoscopic novices are able to reach a comparable level of endoscopic skills as in the above-described projects. METHODS: Twenty-seven endoscopic novices (medical students, first year residents) were enrolled in this prospective, randomised trial. The compact Erlangen Active Simulator for Interventional Endoscopy-simulator with an upper GI-organ package and blood perfusion system was used as a training tool. Basic evaluation of endoscopic skills was performed after a practical and theoretical course in diagnostic upper GI endoscopy followed by a stratified randomisation according to the rating in endoscopic skills into intensive (n=14) and control group (n=13). The intensive group was trained 12 times every second week over 7 months in 4 endoscopic disciplines (manual skills, injection therapy, haemoclip, band ligation) by skilled endoscopist (three trainees/simulator). Assessment was performed (single steps/overall) using an analogue scale from 1 to 10 (1=worst, 10=optimal performance) by expert tutors. The control group was not trained. Blinded final evaluation of all participants was performed in January 2003. RESULTS: We observed in all techniques applied a significant improvement of endoscopic skills and of the performance time in the intensive group compared to the control group (p<0.001). The comparison with the previous projects showed that the intensively trained novices achieved comparable levels of performance to the GI fellows in the New York and France Project (at least 80% of the median score in three out of four techniques). CONCLUSION: Endoscopic novices acquired notable skills in interventional endoscopy in the simulator by an intensive, periodical training using the compactEASIE.

"Hemodynamic efficacy" of two endoscopic clip devices used in the treatment of bleeding vessels, tested in an experimental setting using the compact Erlangen Active Simulator for Interventional Endoscopy (compactEASIE) training model.

BACKGROUND AND STUDY AIMS: Hemoclip therapy is a well-established procedure in the treatment of gastrointestinal bleeding. Although new products are provided periodically by the industry, comparative investigations are lacking. We compared two different hemoclip devices in an experimental setting, assessing them using objective hemostatic parameters. MATERIALS AND METHODS: We compared two disposable clip devices (Olympus HX-200L-135 (n = 40) vs. Wilson-Cook Tri-Clip (n = 40)) in an experimental setting using the compact Erlangen Active Simulator for Interventional Endoscopy (compactEASIE) training model equipped with an upper gastrointestinal-organ package for bleeding simulation. This was a randomized, prospective, controlled trial. Four investigators with different levels of endoscopic experience applied ten hemoclip devices of each type to the spurting vessels, the clips allocated using a randomized list for each investigator. The efficacy of hemostasis was determined by continuous measurement of the pressure within the afferent vessel before and after clip application and calculation of the relative reduction of vessel diameter by the clip device. The system pressure was recorded over the period from 1 minute before to 1 minute after clip application. A secondary end point was a subjective assessment of the whole clip application procedure by the endoscopist and the assisting nurse, using a visual analog scale (0 - 100, with 100 representing the best experience). RESULTS: A total of 39/40 clips of each type were applied successfully. Both clip devices led to a significant increase in system pressure, representing significant relative reduction of vessel diameter (Olympus 5.4 +/- 7.5 %, p < 0.001; Cook 4.9 +/- 8.0 %, p < 0.001). Overall, there was no significant difference between the two devices ( P = 0.756). However, the investigator with the least experience in endoscopy (< 100 procedures) produced significantly inferior results compared with the other three investigators, who had performed between 2000 and 6000 procedures each ( P < 0.05). We found no evidence of a learning curve from the intra-observer results. The devices received good, but not significantly different, overall ratings by the endoscopists (Olympus 69 +/- 24 vs. Wilson-Cook 65 +/- 16) and by the assisting nurses (Olympus 77 +/- 9 vs. Wilson-Cook 70 +/- 22). CONCLUSIONS: Using an established cadaveric training model, no significant difference was found between the two types of hemoclip devices with respect to their "hemostatic efficacy". However, the experience of the endoscopist appears to play a major role in successful clip application. The use of a feedback mechanism in emergency endoscopy training, using continuous intravessel pressure monitoring, may substantially enhance the efficacy of training, resulting in a similar improvement in clinical results.

Objective benefit of a 1-day training course in endoscopic hemostasis using the "compactEASIE" endoscopy simulator.

BACKGROUND AND STUDY AIMS: The Erlangen Active Simulator for Interventional Endoscopy (EASIE) was introduced in 1997 as a training model for interventional endoscopy. Objective evidence of the benefits of training with this model has not previously been published. As part of two long-term projects, the benefits of a 1-day training course with the "compactEASIE" simulator were evaluated. MATERIALS AND METHODS: Fourteen American and 18 French gastroenterology fellows were enrolled. These fellows were participants in the intensive groups performing training in endoscopic hemostasis, with a total number of 28 fellows in New York and 36 in France. Gastrointestinal endoscopy faculty members in New York and France evaluated and timed the fellows in four disciplines to establish baseline skills (manual skills; injection and coagulation; Hemoclip application; and variceal ligation) with the compactEASIE simulator. The trainees were reevaluated after an intensive 1-day course (with two or three fellows and one instructor per station), also including preparation and assistance for each procedure. The assessment (overall and parts) was done by expert tutors using an ordinal scale ranging from 1 to 10 (1 = poorest, 10 = best), recording also mistakes and performance time. The compactEASIE simulator, equipped with an upper gastrointestinal organ package and an artificial blood perfusion system, was used as the training tool. RESULTS: A highly significant improvement ( P < or = 0.001) was observed in the performance of all endoscopic techniques. A significant reduction in performance time was also observed with three of the four endoscopic techniques. Successful hemostasis was significantly improved in two out of three techniques. CONCLUSIONS: A 1-day training course on endoscopic hemostasis using the compactEASIE simulator is capable of improving the performance of hemostasis procedures. Long-term effects of repeated training sessions are currently subject of collaborative studies in New York and France.

Successful laserlithotripsy in Bouveret's syndrome using a new frequency doubled doublepulse Nd:YAG laser (FREDDY).

Gastric outlet obstruction as a result of gallstone (Bouveret syndrome) is a rare but serious complication of cholelithiasis. In many cases, surgery has been conducted for treatment. In recent years, minimal invasive treatment modalities (e.g. shockwave lithotripsy) have been shown to be effective in some of those patients. Laserlithotripsy has so far been described in two cases with a Rhodamine-6G dye laser. We present the case of a 90-year-old woman with duodenal obstruction due to a huge gallstone. The patient was referred to our hospital because attempts at endoscopic extraction and extracorporeal shockwave lithotripsy had failed. The man was treated successfully in just one session with a new cost-efficient frequency doubled doublepulse Nd:YAG laser (FREDDY) using a total of 5726 laser pulses (120 mJ pulse energy, 10 Hz pulse repetition rate) and recovered rapidly. Laserlithotripsy can be considered an effective non-invasive therapeutic alternative to surgical treatment in Bouveret's syndrome, especially in old or high-risk patients.

The compact Erlangen Active Simulator for Interventional Endoscopy: a prospective comparison in structured team-training courses on "endoscopic hemostasis" for doctors and nurses to the "Endo-Trainer" model.

BACKGROUND: In 1997 Hochberger and Neumann presented the "Erlangen Biosimulation Model" (commercialized as the "Erlangen Endo-Trainer") at various national and international meetings. The new compactEASIE is a simplified version of the original "Biosimulation Model" (Endo-Trainer) and is specially designed for easy handling. CompactEASIE is reduced in its features, focusing exclusively on flexible endoscopy training. The acceptance of training in endoscopic hemostasis is accepted by workshop participants, as evaluated by a questionnaire on both models. METHODS: Eleven structured courses on endoscopic hemostasis for doctors and nurses organized by the same endoscopists from 3/1998 to 5/1999 were evaluated using one of both models. The questionnaires were filled in by 207/291 trainees (71%). The Endo-Trainer was used in 4 (n = 103) and the compactEASIE in 7 courses (n = 104). Both simulators were equipped with identical types of specially prepared pig-organ packages consisting of esophagus, stomach and duodenum, including artificial sewn-in vessels, polyps and varices. Blood perfusion was done with a roller pump connected to the sewn-in vessels and blood surrogate. All workshops were identical concerning the course structure: a 30-min theoretical introduction on ulcer bleeding was followed by 2 h of practical training in injection techniques and hemoclip application. The second part of variceal therapy consisted of a 30-min theoretical introduction prior to 2 h of practical training on sclerotherapy, band ligation and cyanoacrylate application. Finally, a questionnaire on the trainees' pre-experience and their rating of the different workshop sections was handed out to each participant. RESULTS: Previous endoscopic experience was comparable in both groups. The training in both simulators was highly accepted by the trainees (compactEASIE 95% excellent and good versus EASIE (Endo-Trainer) 97%) and did not show any significant difference (P = 0.493). Even in the assessment of the single techniques, no statistical difference was observed. Furthermore, the assessments of the closeness to reality and the endoscopic environment in both simulators were identical. CONCLUSIONS: Both simulators (Endo-Trainer, compactEASIE) are excellent educational tools for interventional endoscopy with a high level of acceptance. The easy-to-handle, "lightweight" compactEASIE is a significant, progress tool for the future.

Endoscopic antireflux treatment: fact, fiction or future?

Medical therapy with proton pump inhibitors (PPIs), aside from surgery, is the established and most effective treatment approach for chronic gastroesophageal reflux disease (GERD). Recently developed endoscopic antireflux procedures may be an alternative for a subset of patients with uncomplicated, mild GERD. Given the perioperative morbidity and mortality risk of laparoscopic fundoplication, less invasive semi-surgical and flexible endoscopic techniques may be an option for patients who cannot or wish not to take long-term medication. These clinical procedures include endoscopic suturing devices, focal radiofrequency coagulation in the cardia and bioimplants. While many of these techniques have shown good results in preliminary studies, long-term results are not yet available and therefore all such procedures have to be considered experimental. Their effectiveness will need to be compared with that of established treatment forms.