Endoscopic direct clipping versus indirect clipping for colonic diverticular bleeding: A large multicenter cohort study.

BACKGROUND: Direct and indirect clipping treatments are used worldwide to treat colonic diverticular bleeding (CDB), but their effectiveness has not been examined in multicenter studies with more than 100 cases. OBJECTIVE: We sought to determine the short- and long-term effectiveness of direct versus indirect clipping for CDB in a nationwide cohort. METHODS: We studied 1041 patients with CDB who underwent direct clipping (n = 360) or indirect clipping (n = 681) at 49 hospitals across Japan (CODE BLUE-J Study). RESULTS: Multivariate analysis adjusted for age, sex, and important confounding factors revealed that, compared with indirect clipping, direct clipping was independently associated with reduced risk of early rebleeding (<30 days; adjusted odds ratio [AOR] 0.592, p = 0.002), late rebleeding (<1 year; AOR 0.707, p = 0.018), and blood transfusion requirement (AOR 0.741, p = 0.047). No significant difference in initial hemostasis rates was observed between the two groups. Propensity-score matching to balance baseline characteristics also showed significant reductions in the early and late rebleeding rates with direct clipping. In subgroup analysis, direct clipping was associated with significantly lower rates of early and late rebleeding and blood transfusion need in cases of stigmata of recent hemorrhage with non-active bleeding on colonoscopy, right-sided diverticula, and early colonoscopy, but not with active bleeding on colonoscopy, left-sided diverticula, or elective colonoscopy. CONCLUSIONS: Our large nationwide study highlights the use of direct clipping for CDB treatment whenever possible. Differences in bleeding pattern and colonic location can also be considered when deciding which clipping options to use.

Agente hemostático endoscópico derivado de polisacárido: Endoclot / Polysaccharide-derived endoscopic hemostatic agent: Endoclot

INTRODUCIÓN: Se realiza la siguiente revisión rápida: "Agente hemostático endoscópico derivado de polisacárido: Endoclot", en respuesta a la solicitud de opinión técnica sobre la adquisición de insumos médicos para el Equipo Funcional de Gastroenterología. 2. Se formuló una estrategia de búsqueda de información, que abarcó un periodo de 10 años. Se emplearon las bases de datos: Cochrane y PubMed. 3. Existe evidencia científica poco robusta que avala la eficacia y seguridad de este insumo. ESTRATEGIA DE BÚSQUEDA DE INFORMACIÓN: a) Pregunta Clínica: ¿Es el agente hemostático endoscópico derivado de polisacárido: EndoClot, efectivo y seguro en el manejo de pacientes con hemorragia digestiva, en comparación a otros métodos hemostáticos endoscópicos? ¿Es el agente hemostático endoscópico derivado de polisacárido: Endoclot, efectivo y seguro en la profilaxis de hemorragia digestiva post procedimientos de resección endoscópicos? Recolecciòn de los Manuscritos a Revisar: La estrategia de búsqueda sistemática de información científica para el desarrollo del presente informe se realizó siguiendo las recomendaciones de la Pirámide jerárquica de la evidencia propuesta por Haynes y se consideró los siguientes estudios: Sumarios y guías de práctica clínica. Revisiones sistemáticas y/o meta-análisis. Ensayos Controlados Aleatorizados (ECA). Estudios Observacionales (cohortes, caso y control, descriptivos). Términos de Búsqueda: Considerando las preguntas PICO se construyó una estrategia de búsqueda. Sin restricciones en el idioma y publicadas en los últimos 10 años. DISCUSIÓN: La calidad de evidencia es baja. En el escenario del uso de EndoClot en HD, no se cuenta al momento con ETS que hayan revisado esta tecnología en ningún escenario clínico. No hay recomendaciones de Guías de Prácticas Clínicas (GPC) sobre el uso de EndoClot en algún escenario en particular. En la GPC del 2020 de la Sociedad Europea de Endoscopía, sobre el manejo de HDANV, recomiendan el uso de hemostáticos tópicos tipo HemoSpray, pero no emiten opinión sobre EndoClot ya que aluden, falta de evidencia. Por otro lado, solo se ha podido encontrar una Revisión Sistemática con meta análisis, en la cual hace alusión al empleo en general de los polvos hemostáticos. En esta revisión sistemática, los estudios incluidos con EndoClot solo fueron 4 y de tipo observacional, por lo que el resultado positivo de esta revisión se da más por los estudios con HemoSpray que por EndoClot y en el análisis por intervención se apreció que hubo una alta heterogeneidad en el grupo de EndoClot, por lo cual la conclusión que EndoClot es eficaz debe ser tomada con cautela. Aún no se cuenta con resultados publicados de ensayos clínicos que comparen las técnicas convencionales en el manejo de las HD y EndoClot. En el escenario del uso de EndoClot en profilaxis de sangrado post procedimientos endoscópicos, tampoco se encontraron ETS sobre esta tecnología. No hay GPC que hagan recomendación de uso ni tampoco existe alguna revisión sistemática con meta análisis sobre este tema en particular. Se tiene sólo un ECA y es negativo para la eficacia de EndoClot en este escenario. Además, se obtuvieron 2 estudios observacionales positivos sobre la eficacia de EndoClot pero fueron con un número reducido de casos. Como se puede apreciar, no hay al momento, evidencia suficiente de calidad para hacer algún tipo de recomendación sobre los dos escenarios de uso de EndoClot solicitados. La magnitud del beneficio al momento es incierto, pues dentro de las indicaciones encontradas en esta evaluación, se encuentran pacientes con diagnóstico de HD y como profilaxis de sangrado post procedimientos endoscópicos, sin embargo, debido a la poca evidencia al momento, el beneficio real de la intervención no se puede estimar con certeza. El impacto económico de esta tecnología para el INEN es incierta. Debido a que el costo anual del agente hemostático endoscópico por polisacárido es sostenible, al carecer de evidencia científica robusta, un AIP no se hace necesario al momento. Además, el costo del hemoclip, que es una tecnología con la cual contamos en el instituto, que ha demostrado eficacia y es recomendada en las GPC, es de S/ 1 000.00, por lo cual se podría inferir que esta última es más costo - efectiva que EndoClot. El área usuaria, Gastroenterología, señala que la demanda de uso podría aumentar a medida que se disponga en stock de farmacia estos insumos, ya que esta sería empleada durante las HD superiores e inferiores, así como profilaxis luego de procedimientos endoscópicos: mucosectomías y disección submucosa. Un estimado de 1 paciente semanal, podría ser el requerimiento de uso si se contara con el insumo solicitado de forma permanente. Según el área de logística, la última compra del agente hemostático endoscópico por polisacárido (Endoclot), fue realizada en el año 2019, con 20 unidades durante todo el año. En el año 2018, se registraron las mismas unidades de compra. El área usuaria manifestó que todos los casos fueron exitosos en el control de la hemorragia y que se evitaron así, procedimientos quirúrgicos para el control del sangrado. CONCLUSIONES: La hemorragia digestiva es un problema para el endoscopista, tanto en frecuencia como en esfuerzo técnico. Nuevos agentes hemostáticos han surgido en los últimos años, demostrando eficacia en diferentes procedimientos quirúrgicos y endoscópicos. El empleo de estos agentes hemostáticos, al momento, no cuentan con recomendaciones en GPC para el manejo y profilaxis de las hemorragias digestivas. No existe al momento evidencia robusta que avale el empleo de este tipo de agentes en el manejo y profilaxis de pacientes con hemorragia digestiva. El agente hemostático endoscópico por polisacárido, Endoclot, es comercializado a nivel nacional. Cuenta con Código SIGAMEF y Registro Sanitario. Además, ya hemos contado con esta tecnología en nuestra institución. Por lo expuesto, la UFETS en consenso con el panel, no puede emitir, al momento, opinión a favor para el uso de la tecnología: agente hemostático endoscópico derivado de polisacárido - Endoclot.

Cutting-Edge Technologies for Gastrointestinal Therapeutic Endoscopy.

With advancements in the development of flexible endoscopes and endoscopic devices and the increased demand for minimally invasive treatments, the indications of therapeutic endoscopy have been expanded. Methods of endoscopic treatment used for tissue removal, hemostasis, and dilatation are as follows. Endoscopic submucosal dissection (ESD) is considered the gold standard curative method for removal of gastrointestinal node-negative neoplasms, regardless of their size or the presence of ulcer formation. Laparoscopic endoscopic cooperative surgery (LECS), which incorporates ESD, was introduced for removal of lesions in deeper layers. Another technique is endoscopic full-thickness resection, which is challenging without the assistance of laparoscopy. In terms of hemostasis, management of iatrogenic bleeding after endoscopic treatment is an important issue. Shielding methods and suturing techniques have been introduced for large mucosal defects after ESD, and their efficacy has been investigated clinically. Peroral endoscopic myotomy (POEM) is a new alternative surgical approach for minimally invasive treatment of esophageal achalasia. Furthermore, endoscopic fundoplication after POEM was devised to prevent post-POEM gastroesophageal reflux disease. Many endoscopic treatments, including ESD, LECS, and POEM, have been introduced in Japan. With the aging of the population, more attention will be directed toward therapeutic endoscopy for elderly patients, because it is less invasive. Development of endoscopic treatments with expanded indications is expected.

Over-The-Scope Clip system as a first-line therapy for high-risk bleeding peptic ulcers: a retrospective study.

BACKGROUND: Effective hemostasis is essential to prevent rebleeding. We evaluated the efficacy and feasibility of the Over-The-Scope Clip (OTSC) system compared to combined therapy (through-the-scope clips with epinephrine injection) as a first-line endoscopic treatment for high-risk bleeding peptic ulcers. METHODS: We retrospectively analyzed data of 95 patients from a single, tertiary center and underwent either OTSC (n = 46) or combined therapy (n = 49). The primary outcome of the present study was the efficacy of the OTSC system as a first-line therapy in patients with high-risk bleeding peptic ulcers compared to combined therapy with TTS clips and epinephrine injection. The secondary outcomes included the rebleeding rate, perforation rate, mean procedure time, reintervention rate, mean procedure cost and days of hospitalization in the two study groups within 30 days of the index procedure. RESULTS: All patients achieved hemostasis within the procedure; two patients in the OTSC group and four patients in the combined therapy group developed rebleeding (p = 0.444). No patients experienced gastrointestinal perforation. OTSC had a shorter median procedure time than combined therapy (11 min versus 20 min; p < 0.001). The procedure cost was superior for OTSC compared to combined therapy ($102,000 versus $101,000; p < 0.001). We found no significant difference in the rebleeding prevention rate (95.6% versus 91.8%, p = 0.678), hospitalization days (3 days versus 4 days; p = 0.215), and hospitalization costs ($108,000 versus $240,000, p = 0.215) of the OTSC group compared to the combined therapy group. CONCLUSION: OTSC treatment is an effective and feasible first-line therapy for high-risk bleeding peptic ulcers. OTSC confers comparable costs and patient outcomes as combined treatments, with a shorter procedure time.

Cumulative evidence for reducing recurrence of colonic diverticular bleeding using endoscopic clipping versus band ligation: Systematic review and meta-analysis.

BACKGROUND AND AIM: Either clipping or band ligation will become the most common endoscopic treatment for colonic diverticular bleeding (CDB). Rebleeding is a significant clinical outcome of CDB, but there is no cumulative evidence comparing reduction of short-term and long-term rebleeding between them. Thus, we conducted a systematic review and meta-analysis to determine which endoscopic treatment is more effective to reduce recurrence of CDB. METHODS: A comprehensive search of the databases PubMed/MEDLINE and Embase was performed through December 2019. Main outcomes were early and late rebleeding rates, defined as bleeding within 30 days and 1 year of endoscopic therapy for CDB. Initial hemostasis, need for transcatheter arterial embolization, or surgery were also assessed. Overall pooled estimates were calculated. RESULTS: Sixteen studies fulfilled the eligibility criteria, and a total of 790 participants were included. The pooled prevalence of early rebleeding was significantly lower for band ligation than clipping (0.08 vs 0.19; heterogeneity test, P = 0.012). The pooled prevalence of late rebleeding was significantly lower for band ligation than clipping (0.09 vs 0.29; heterogeneity test, P = 0.024). No significant difference of initial hemostasis rate was noted between the two groups. Pooled prevalence of need for transcatheter arterial embolization or surgery was significantly lower for band ligation than clipping (0.01 vs 0.02; heterogeneity test, P = 0.031). There were two cases with colonic diverticulitis due to band ligation but none in clipping. CONCLUSION: Band ligation therapy was more effective compared with clipping to reduce recurrence of colonic diverticular hemorrhage over short-term and long-term durations.

AGA Clinical Practice Update on Endoscopic Therapies for Non-Variceal Upper Gastrointestinal Bleeding: Expert Review.

DESCRIPTION: The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update is to review the available evidence and best practice advice statements regarding the use of endoscopic therapies in treating patients with non-variceal upper gastrointestinal bleeding. METHODS: This expert review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Gastroenterology. This review is framed around the 10 best practice advice points agreed upon by the authors, which reflect landmark and recent published articles in this field. This expert review also reflects the experiences of the authors who are gastroenterologists with extensive experience in managing and teaching others to treat patients with non-variceal upper gastrointestinal bleeding (NVUGIB). BEST PRACTICE ADVICE 1: Endoscopic therapy should achieve hemostasis in the majority of patients with NVUGIB. BEST PRACTICE ADVICE 2: Initial management of the patient with NVUGIB should focus on resuscitation, triage, and preparation for upper endoscopy. After stabilization, patients with NVUGIB should undergo endoscopy with endoscopic treatment of sites with active bleeding or high-risk stigmata for rebleeding. BEST PRACTICE ADVICE 3: Endoscopists should be familiar with the indications, efficacy, and limitations of currently available tools and techniques for endoscopic hemostasis, and be comfortable applying conventional thermal therapy and placing hemoclips. BEST PRACTICE ADVICE 4: Monopolar hemostatic forceps with low-voltage coagulation can be an effective alternative to other mechanical and thermal treatments for NVUGIB, particularly for ulcers in difficult locations or those with a rigid and fibrotic base. BEST PRACTICE ADVICE 5: Hemostasis using an over-the-scope clip should be considered in select patients with NVUGIB, in whom conventional electrosurgical coagulation and hemostatic clips are unsuccessful or predicted to be ineffective. BEST PRACTICE ADVICE 6: Hemostatic powders are a noncontact endoscopic option that may be considered in cases of massive bleeding with poor visualization, for salvage therapy, and for diffuse bleeding from malignancy. BEST PRACTICE ADVICE 7: Hemostatic powder should be preferentially used as a rescue therapy and not for primary hemostasis, except in cases of malignant bleeding or massive bleeding with inability to perform thermal therapy or hemoclip placement. BEST PRACTICE ADVICE 8: Endoscopists should understand the risk of bleeding from therapeutic endoscopic interventions (eg, endoluminal resection and endoscopic sphincterotomy) and be familiar with the endoscopic tools and techniques to treat intraprocedural bleeding and minimize the risk of delayed bleeding. BEST PRACTICE ADVICE 9: In patients with endoscopically refractory NVUGIB, the etiology of bleeding (peptic ulcer disease, unknown source, post surgical); patient factors (hemodynamic instability, coagulopathy, multi-organ failure, surgical history); risk of rebleeding; and potential adverse events should be taken into consideration when deciding on a case-by-case basis between transcatheter arterial embolization and surgery. BEST PRACTICE ADVICE 10: Prophylactic transcatheter arterial embolization of high-risk ulcers after successful endoscopic therapy is not encouraged.

Systematic review and meta-analysis: monopolar hemostatic forceps with soft coagulation in the treatment of peptic ulcer bleeding.

Monopolar hemostatic forceps with soft coagulation (MHFSC) have been compared with hemoclips, heater probe, and argon plasma coagulation (APC) for the treatment of peptic ulcer bleeding. In this systematic review and meta-analysis, we compared MHFSC with other modalities in the treatment of peptic ulcer bleeding. We reviewed MEDLINE, Embase, Scopus, Cochrane, Web of Science, and Scopus from inception to 7 January 2019 to identify studies comparing MHFSC with other modalities for peptic ulcer bleeding. The primary outcome of interest was achievement of initial hemostasis. Secondary outcomes were rebleeding, adverse events, procedure time, and length of hospital stay. Data were analyzed using a random effects model and summarized as pooled odds ratio (OR) with 95% confidence interval (CI). Heterogeneity was assessed by I statistic. We included five randomized controlled trials and one observational study comprising 693 patients with endoscopically confirmed actively bleeding ulcers (spurting or oozing) or nonbleeding visible vessel. MHFSC was superior to other modalities in achieving initial hemostasis (OR 0.25; 95% CI 0.08-0.81; I = 67%) and prevention of rebleeding (OR 0.28; 95% CI 0.09-0.86; I = 46%). Rates of adverse events were similar between MHFSC and other modalities. Procedure times were shorter with MHFSC (mean difference -4.15 min; 95% CI -4.83 to -3.47; I= 59%). Length of hospital stay was also shorter with MHFSC. MHFSC appears to be more effective than other modalities for achievement of initial hemostasis and reduction of rebleeding among patients with peptic ulcer bleeding.

Recent Trends in Treatment for Colonic Diverticular Bleeding in Japan.

BACKGROUND: In both Western countries and in Japan, the incidence of colonic diverticular bleeding has increased with increased use of antithrombotic and nonsteroidal anti-inflammatory drugs (NSAIDs). Therefore, the Japan Gastroenterological Association issued guidelines for colonic diverticular bleeding and colonic diverticulitis in Japanese in 2017 and in English in 2019. However, the guidelines contain unresolved problems. Herein, we review the recent treatment trends for colonic diverticular bleeding in Japan. SUMMARY: Colonic diverticular bleeding necessitates frequent blood transfusions due to rebleeding, and patients require prolonged hospitalization. Endoscopic treatment plays an important role in treating diverticular bleeding. Currently, endoscopic band ligation (EBL) and endoscopic clipping are used in Japan for diverticular hemorrhage when the source of the hemorrhage is identified. EBL results in significantly lower early (<30 days) and 1-year rebleeding rates and long-term recurrence rates compared with endoscopic clipping. Furthermore, the proportion of patients requiring transcatheter arterial embolization or surgery after EBL is significantly lower than that following endoscopic clipping. Several reports state that EBL is superior to endoscopic clipping; however, EBL has associated complications, and it is necessary to carefully consider the individual patient. Key Messages: EBL is superior to endoscopic clipping regarding short- and long-term rebleeding rates and the rate of transition to surgery and embolization. Methods for preventing diverticular hemorrhage have not been established, but NSAIDs should be discontinued if possible. Prevention strategies for diverticular bleeding need to be evaluated in studies with large sample sizes.

Endoscopic Detachable Snare Ligation Improves the Treatment for Colonic Diverticular Hemorrhage.

BACKGROUND/AIMS: Recently, endoscopic detachable snare ligation (EDSL) has become increasingly common as treatment for colonic diverticular hemorrhage. This study aimed to evaluate the efficacy and safety of EDSL in comparison with endoscopic clipping (EC) as treatment for colonic diverticular hemorrhage. METHODS: From April 2013 to September 2017, 131 patients were treated with EDSL or EC at the Tokyo Metropolitan Bokutoh Hospital. We retrospectively evaluated patient characteristics and clinical outcomes, including early rebleeding rates (rebleeding within 30 days after initial hemostasis) and complications for each procedure. RESULTS: Of 131 patients, 44 and 87 were treated with EDSL and EC respectively. We initially achieved endoscopic hemostasis in all patients. The early rebleeding rate was significantly lower for EDSL (6.8%, 3 patients) than for EC (23.0%, 20 patients). There were no differences in the total procedure time (43 vs. 45 min, p = 0.84) or time to hemostasis after identification of bleeding site (12 vs. 10 min, p = 0.23). There were no severe complications following EDSL. CONCLUSION: The results of this study suggest that EDSL is superior to EC as treatment for colonic diverticular hemorrhage. EDSL may provide improvements in the clinical course of patients with colonic diverticular hemorrhage.

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.

[OUTCOMES OF CHRONIC UNILATERAL HEMATURIA TREATED USING DIGITAL FLEXIBLE URETEROSCOPE].

(Objectives) We examined the treatment outcomes in cases of chronic unilateral hematuria treated using flexible ureteroscope for observation and hemostasis. (Methods) The study included 14 patients (7 men and 7 women) with a median age of 56.5 years who underwent ureteroscopy using a digital flexible ureteroscope for chronic unilateral hematuria between March 2014 and August 2019. All the patients presented with macroscopic hematuria as a clinical symptom, but in one patient, the hematuria was accompanied by anemia and required a blood transfusion. In addition, bleeding occurred on the left side in 8 patients and on the right side in 3 patients; however, for the remaining 3 patients, the affected side could not be identified. Fourteen patients were examined on the basis of the ureteroscopic findings, number of bleeding sites, hemostatic intervention, treatment effect, and presence or absence of recurrences. (Results) The ureteroscopic findings showed a hemangioma in 7 patients and minute venous rupture in 3, but the remaining 4 patients showed no clear findings. The site of the findings was in the superior calyces in 8 cases, middle calyces in 4 cases, inferior calyces in 4 cases, and renal pelvic wall in 1 case. In addition, the findings were located at multiple sites in 6 cases, including all renal calyces in 2 cases. Ten patients with findings underwent hemostatic interventions (electrocoagulation and laser treatment). The median postoperative follow-up period was 32.4 months (range, 6.4-65.4 months). In all the cases, the hematuria disappeared after treatment. One of the 2 patients with findings in all renal calyces showed recurrence of macroscopic hematuria at 1 year and 6 months, which disappeared after conservative treatment. (Conclusions) In this study, observation using digital flexible ureteroscope was useful in the treatment of chronic unilateral hematuria, and the hemostatic interventions performed on the bleeding sites in the renal pelvis were effective.

The Use of the Over the Scope Clip to Treat Upper Gastrointestinal Bleeding.

The over-the-scope clip is a novel endoscopic tool developed for tissue compression in the gastrointestinal tract. It has already revolutionized the management of acute perforations and leaks. In the past decade, it has also increasingly been used for treatment of severe and/or refractory gastrointestinal hemorrhage. Available studies report high rates of primary hemostasis and rebleeding. This article provides an overview on available literature, potential indications, and technical aspects of hemostasis with over-the-scope clip.

Use of the Endoscopic Clipping Over the Scope Technique to Treat Acute Severe Lower Gastrointestinal Bleeding in the Colon and Anal Transition Zone.

Endoscopic treatment of lower gastrointestinal bleeding can be challenging. This article reports on the use of the endoscopic clipping over the scope technique to treat acute severe lower gastrointestinal bleeding. In particular, it describes the approaches and outcomes of using the technique for acute severe bleeding in the colon and the anal transition zone. The following synopsis is the one that you supplied, but lightly copyedited. Please confirm OK. Please note that the synopsis will appear in PubMed: Endoscopic treatment of lower gastrointestinal bleeding can be challenging. This article reports on the use of the endoscopic clipping over the scope technique to treat acute severe lower gastrointestinal bleeding. In particular, it describes the approaches and outcomes of using the technique for acute severe bleeding in the colon and the anal transition zone.

Clipping Over the Scope for Recurrent Peptic Ulcer Bleeding is Cost-Effective as Compared to Standard Therapy: An Initial Assessment.

Clipping over the scope (C-OTS) is a novel closure technique used for the treatment of nonvariceal gastrointestinal bleeding, especially for high-risk lesions. C-OTS devices cost more than clipping through the scope and thermal devices. The high upfront cost of C-OTS may pose a barrier to its use and the cost-effectiveness of C-OTS for peptic ulcer disease bleeding is unknown. Cost-effectiveness studies of C-OTS for peptic ulcer bleeding as both first-line and second-line therapy can provide the current estimate of the conditions in which the use of C-OTS is cost-effective and give insights of the determinants to the cost-effectiveness of C-OTS.

Clinical outcomes of over-the-scope-clip system for the treatment of acute upper non-variceal gastrointestinal bleeding: a systematic review and meta-analysis.

BACKGROUND: Conventional endoscopic treatments can't control bleeding in as many as 20% of patients with non-variceal gastrointestinal (GI) bleeding. Recent studies have shown that over-the-scope-clip (OTSC) system allowed for effective hemostasis for refractory GI bleeding lesions. So we aimed to conduct a systematic review to evaluate the effectiveness and safety of the OTSC system for management of acute non-variceal upper GI bleeding. METHOD: A comprehensive literature search was conducted on PubMed, EMBASE, and Cochrane Library covering the period from January 2007 to May 2019. The literature was selected independently by two reviewers according to the inclusion and exclusion criteria. The statistical analysis was carried out using Comprehensive Meta-Analysis software version 3.0. RESULTS: A total of 16 studies including 769 patients with 778 GI bleeding lesions were identified. Pooled technical success was achieved in 761 lesions [95.7%; 95% confidence interval (CI), 93.5-97.2%], and the pooled clinical success was achieved in 666 lesions (84.2, 95% CI, 77.4-89.2%). The incidence of re-bleeding was reported in 81 patients and the post-procedure mortality was 10.9% (n = 84). Only 2 (0.3%) patients occurred complications after OTSC system procedure. CONCLUSIONS: Our study demonstrated that the OTSC system was a technically feasible modality and highly efficacious in achieving hemostasis in acute non-variceal upper gastrointestinal bleeding.

Efficacy and safety of over-the-scope clips for gastrointestinal bleeding: a systematic review and meta-analysis.

BACKGROUND: The over-the-scope clip (OTSC) has been increasingly utilized for the management of gastrointestinal (GI) bleeding. Limited efficacy data are currently available from large-scale studies. METHODS: An electronic database search was conducted for eligible articles using OTSCs for hemostasis in GI bleeding. The primary outcome was the rate of definitive hemostasis after primary hemostasis and without rebleeding at follow-up. Secondary outcomes were: primary technical success, primary clinical success, rebleeding, and failure rates. Pooled rates were expressed as proportions of patients with events over total patients, 95 % confidence limits (CI) with heterogeneity, and P values of < 0.05 for significance. RESULTS: A total of 21 studies (n = 851) were analyzed (62.2 % males), with a median patient age of 69.7 years. The definitive hemostasis rate was 87.8 % (95 %CI 83.7 % - 92 %) after a median follow-up of 56 days. The OTSC was successfully deployed in 97.8 % of patients (95 %CI 96.7 % - 98.9 %) and the primary clinical success rate was 96.6 % (95 %CI 95.1 % - 98.2 %). Rebleeding was seen in 10.3 % of patients (95 %CI 6.5 % - 14.1 %). The failure rate of OTSCs was 9 % (95 %CI 5.2 % - 12.8 %) when used as first-line treatment and 26 % (95 %CI 16.1 % - 36.0 %) when used as second-line treatment. CONCLUSION: This systematic review showed high rates of definitive hemostasis, technical success, and clinical success, along with low rebleeding rates when OTSCs were used for the treatment of GI bleeding. The lack of randomized controlled trials of OTSC vs. other therapies makes comparison with conventional treatment difficult.