Abordatge endoscòpic multidisciplinari de tumors subepitelials gastrointestinals de petita mida: lligadura amb banda sense resecció i ansietat-carcinofòbia

[cat] INTRODUCCIÓ: Els tumors subepitelials gastrointestinals (TSE-GI) inespecífics de petita mida requereixen d’un control periòdic endoscòpic degut al risc que es tractin d’entitats amb potencial de malignització. Malgrat aquesta possibilitat és significativament baixa, el terme “tumor” sol associar-se per part dels i les pacients amb el concepte de “malaltia maligna i possibilitat de càncer”. L’extirpació endoscòpica d’aquest tipus de lesions per mitjà de la lligadura amb banda sense resecció (LLBSR) combinada amb una biòpsia tipus single-incision needle-knife (SINK) és una opció poc reportada en la literatura, essent aparentment una tècnica més segura que les emprades habitualment en resecció endoscòpica. HIPÒTESIS: La LLBSR combinada amb biòpsia SINK és una tècnica efectiva en el maneig dels TSEGI de petita mida. Els TSE-GI generen ansietat-destret i carcinofòbia en els/les pacients diagnosticats/es amb aquest tipus de lesions. OBJECTIUS: Avaluar l'efectivitat de la LLBSR combinada amb biòpsia SINK en el tractament dels TSE-GI de petita mida a curt, mitjà i llarg termini. Analitzar la seguretat, grau de dificultat i factibilitat de la tècnica. Reportar la rendibilitat diagnòstica de la biòpsia SINK. Valorar l’impacte en el maneig clínic dels TSE-GI de petita mida en optar per l’estratègia LLBSR+SINK. Avaluar el grau d’ansietat-destret i carcinofòbia en els/les pacients diagnosticats/es amb un TSE-GI de petita mida. Cercar possibles factors associats a presentar un major o menor grau d’ansietatdestret i/o carcinofòbia. MÈTODES: Estudi 1 (BANDING-TSE): Estudi de cohort multicèntric amb 7 centres participants, incloent pacients amb un TSE ≤15 mm (confirmats per ultrasonografia endoscòpica [USE]) entre el març de 2017 i el març de 2020. La variable principal es definí com a èxit clínic a les 4 setmanes, entenent com a tal la desaparició completa del TSE per visió USE. Les variables secundàries foren l'avaluació de l'èxit clínic a llarg termini (1 any), el nivell de dificultat tècnica, l'impacte clínic, el rendiment de la biòpsia i la seguretat de la tècnica. Registrat a ClinicalTrials.gov: NCT03247231. Estudi 2 (QUALI-BANDING-TSE): Estudi prospectiu, multicèntric, de cohorts. Es van utilitzar tres qüestionaris específics d'autoresposta per a reportar possibles experiències vitals amenaçadores prèvies (The List of Threatening Experiences), per a avaluar el nivell d'angoixa (The Hospital Anxiety and Depression Scale) i les preocupacions relacionades amb el càncer (The Cancer Worry Scale). Registrat a ClinicalTrials.gov: NCT04316000. RESULTATS: Estudi 1 (BANDING-TSE): Es van seleccionar 273 pacients, incloent-se'n finalment 122 (62,3% dones, edat mitjana de 61 ± 13 anys). Característiques dels TSE: mida mitjana de 9 mm ± 2,8; localització gàstrica en el 77% dels casos i dependència de capes superficials en el 63%. La variable principal s'aconseguí en un 73,6% (IC 95%: 64,8-81,2). A un any de seguiment, la taxa d'èxit fou del 68,4% (IC 95%: 59,1-76,8). El nivell de dificultat va ser alt en un 11%. S'observà un impacte clínic favorable en 97 casos (79,5%, IC 95%: 71,3-86,3). El resultat anatomopatològic del TSE s'aconseguí en un 70%. Les lesions potencialment malignes foren un 24,7% dels casos. La taxa d'esdeveniments adversos relacionats va ser del 4,1% (IC 95%: 1,3-9,3; n=2 sagnat, n=2 dolor abdominal, n=1 laceració mucosa), essent tots ells de tipus lleu. En l'anàlisi multivariable, el subgrup TSE ≤10 mm es va associar amb una taxa d'èxit més gran (a 1 any, 87%; RR 5,07 [IC 95%: 2,63-9,8]) i una major taxa d'impacte clínic (92,7%; RR 6,15 [IC 95%: 2,72- 13,93]). Estudi 2 (QUALI-BANDING-TSE): Es van incloure quaranta participants. Mentre que l'ansietat patològica i límit es va detectar en el 13% (5/40, IC 95%: 4-27) i el 35% (14/40, IC 95%: 21-52) respectivament, la preocupació relacionada amb el càncer (de moderada a molt alta) es va observar en el 48% (19/40, IC 95%: 32-64) dels participants. El destret global patològic es va identificar en el 25% (10/40, IC 95%: 13-42) dels subjectes. Un nivell d'educació superior (estudis universitaris), la manca de comorbiditat psiquiàtrica al llarg de la vida i la manca d'antecedents familiars de càncer es van associar amb una menor ansietat, destret global i carcinofòbia. CONCLUSIONS: La LLBSR combinada amb biòpsia tipus SINK és una tècnica aparentment factible, segura i podria oferir un impacte clínic favorable en el maneig dels TSE de petita mida. Els TSE ≤10 mm són els millors candidats. Gairebé la meitat dels i les pacients diagnosticats/es amb una lesió subepitelial inespecífica de petita mida presenten ansietat-destret i/o carcinofòbia degut a aquest diagnòstic, detectant-se associacions específiques com a possibles factors de risc. L’entesa de la salut com una esfera transversal de la persona, no tan sols de maneig de la patologia orgànica, inspirà el plantejament de la present Tesi, aportant un abordatge i mirada multidisciplinària.[eng] INTRODUCTION: Small nonspecific gastrointestinal subepithelial tumours (GI-SET) require periodic endoscopic surveillance due to the risk of a potentially malignant entity. Although this possibility is significantly low, the term ‘tumour’ is often associated by patients with malignancy and the possibility of cancer. Removal of this type of lesion by endoscopic band ligation (EBL) without resection, combined with a single-incision needle-knife (SINK) biopsy, is a scantily reported option in the literature, apparently seen as a safer technique compared with other commonly used procedures in endoscopic resection. HYPOTHESIS: EBL combined with SINK biopsy is an effective technique in small GI-SET management. GI-SET generates anxiety, distress and carcinophobia in patients diagnosed with this type of lesion. OBJECTIVES: To evaluate the effectiveness of EBL combined with SINK biopsy in GI-SET treatment in short, medium, and long-term follow-up; to analyse the safety, difficulty level, and feasibility of the technique; to report the diagnostic yield of SINK biopsy; to assess the impact of GI-SET on clinical management by opting for the EBL + SINK strategy; to evaluate anxiety, distress and carcinophobia, in patients with a GI-SET diagnosis; and to examine possible factors associated with a greater or lower level of anxiety-disorder and/or carcinophobia. METHODS: Study 1 (BANDING-SET): Prospective multicentre observational cohort study in 7 centres including patients with GI-SETs ≤15mm (confirmed by endoscopic ultrasound [EUS]) between March 2017 and March 2020. The primary outcome was 4 weeks’ clinical success defined as complete SET disappearance at EUS control. Secondary outcomes were long-term (1 year) clinical success, technical difficulty level, clinical impact, yield pathology, and safety of the technique. Registered at ClinicalTrials.gov: NCT03247231. Study 2 (QUALI-BANDING-SET): Prospective, multicentre, cohort study. Three specific self-reported questionnaires were used to report prior life-threatening experiences (The List of Threatening Experiences), to assess level of distress (The Hospital Anxiety and Depression Scale), and cancer-related worries (The Cancer Worry Scale). Registered at ClinicalTrials.gov: NCT04316000. RESULTS: Study 1 (BANDING-SET): Some 273 patients were screened, and 122 (62.3% women, mean age 60.9 ± 13.2) were included with SET (mean size, 9mm ± 2.8; gastric location 77%, superficial layers-dependence 63%). Primary endpoint was achieved in 73.6% (95%CI: 64.8-81.2). At 1-year follow-up, success rate was 68.4% (95%CI: 59.1-76.8). Difficulty level was high in 11%. A favourable clinical impact was observed in 97 cases (79.5%, 95%CI: 71.3-86.3). Pathology diagnosis was known in 70%. Potentially malignant lesions were present in 24.7%. Related-adverse events rate was 4.1% (95%CI: 1.3-9.3; all mild, n=2 bleeding, n=2 abdominal pain, n=1 mucosal laceration). On multivariable analysis, ≤10mm SET group was associated with a greater success rate (1-year, 87%; RR 5.07 [95%CI: 2.63-9.8]) and a higher clinical impact rate (92.7%; RR 6.15 [95%CI: 2.72-13.93]). Study 2 (QUALI-BANDING-SET): Forty participants were included and analysed at baseline. Whereas pathologic and borderline anxiety were detected in 13% (5/40, 95%CI: 4-27) and 35% (14/40, 95%CI: 21-52) respectively, cancer-related worries (moderate to very high) were observed in 48% (19/40, 95%CI: 32-64) of participants. Pathologic global distress was identified in 25% (10/40, 95%CI: 13-42) of subjects. Higher educational level (university studies), lack of lifetime psychiatric comorbidity, and lack of family history of cancer were associated with lower levels of anxiety, global distress, and carcinophobia. CONCLUSIONS: EBL combined with SINK biopsy seems to be a feasible and safe technique, and may offer a favourable clinical impact on the management of small GI-SETs. SETs ≤10 mm are the best candidates. Almost half of patients diagnosed with a small nonspecific subepithelial lesion present anxiety-distress and/or carcinophobia due to this diagnosis, with specific associations being detected as possible risk factors. Improvement of understanding of health as a transversal sphere of the person, and not only in the management of organic pathology, inspired the approach of the present thesis, based upon a multidisciplinary perspective.[spa] INTRODUCCIÓN: Los tumores subepiteliales gastrointestinales (TSE-GI) inespecíficos de pequeño tamaño requieren de un control periódico endoscópico debido al riesgo de que se traten de entidades con potencial de malignización. A pesar que esta posibilidad es significativamente baja, el término “tumor” suele asociarse por parte de los y las pacientes con el concepto de “enfermedad maligna y posibilidad de cáncer”. La extirpación endoscópica de este tipo de lesiones por medio de la ligadura con banda sin resección (LBSR) combinada con una biopsia tipo single-incision needle-knife (SINK) es una opción poco reportada en la literatura, siendo aparentemente una técnica más segura que las utilizadas habitualmente en resección endoscópica. HIPÓTESIS: La LBSR combinada con biopsia SINK es una técnica efectiva en el manejo de los TSEGI de pequeño tamaño. Los TSE-GI generan ansiedad-distrés y carcinofobia en los/las pacientes diagnosticados/as con este tipo de lesiones. OBJETIVOS: Evaluar la efectividad de la LBSR combinada con biopsia SINK en el tratamiento de los TSE-GI de pequeño tamaño a corto, medio y largo plazo. Analizar la seguridad, el grado de dificultad y la factibilidad de la técnica. Reportar la rentabilidad diagnóstica de la biopsia SINK. Valorar el impacto en el manejo clínico de los TSE-GI de pequeño tamaño al optar por la estrategia LBSR+SINK. Evaluar el grado de ansiedad-distrés y carcinofobia en los/las pacientes diagnosticados/as con un TSE-GI de pequeño tamaño. Buscar posibles factores asociados a presentar un mayor o menor grado de ansiedad-distrés y/o carcinofobia. MÉTODOS: Estudio 1 (BANDING-TSE): Estudio de cohorte multicéntrico con 7 centros participantes, incluyendo pacientes con un TSE ≤15 mm (confirmados por ultrasonografía endoscópica [USE]) entre marzo de 2017 y marzo de 2020. La variable principal se definió como éxito clínico a las 4 semanas, entendiendo como tal la desaparición completa del TSE por visión USE. Las variables secundarias fueron la evaluación del éxito clínico a largo plazo (1 año), el nivel de dificultad técnica, el impacto clínico, el rendimiento de la biopsia y la seguridad de la técnica. Registrado en ClinicalTrials.gov: NCT03247231. Estudio 2 (QUALI-BANDING-TSE): Estudio prospectivo, multicéntrico, de cohortes. Se utilizaron tres cuestionarios específicos de autorespuesta para reportar posibles experiencias vitales amenazadoras previas (The List of Threatening Experiences), para evaluar el nivel de angustia (The Hospital Anxiety and Depression Scale) y las preocupaciones relacionadas con el cáncer (The Cancer Worry Scale). Registrado en ClinicalTrials.gov: NCT04316000. RESULTADOS: Estudio 1 (BANDING-TSE): Se seleccionaron 273 pacientes, incluyéndose finalmente 122 (62,3% mujeres, edad media de 60,9 ± 13,2 años). Características de los TSE: tamaño medio de 9 mm ± 2,8; localización gástrica en el 77% de los casos y dependencia de capas superficiales en el 63%. La variable principal se alcanzó en un 73,6% (IC 95%: 64,8-81,2). A un año de seguimiento, la tasa de éxito fue del 68,4% (IC 95%: 59,1-76,8). El nivel de dificultad fue alto en un 11%. Se observó un impacto clínico favorable en 97 casos (79,5%, IC 95%: 71,3- 86,3). El resultado anatomopatológico del TSE se alcanzó en un 70%. Las lesiones potencialmente malignas fueron un 24,7% de los casos. La tasa de eventos adversos relacionados fue del 4,1% (IC 95%: 1,3-9,3; n=2 sangrado, n=2 dolor abdominal, n=1 laceración mucosa), siendo todos ellos de tipo leve. En el análisis multivariable, el subgrupo TSE ≤10 mm se asoció con una mayor tasa de éxito (a 1 año, 87%; RR 5,07 [IC 95%: 2,63-9,8]) y una mayor tasa de impacto clínico (92,7%; RR 6,15 [IC 95%: 2,72-13,93]). Estudio 2 (QUALI-BANDING-TSE): Se incluyeron cuarenta participantes. Mientras que la ansiedad patológica y límite se detectó en el 13% (5/40, IC 95%: 4-27) y el 35% (14/40, IC 95%: 21-52) respectivamente, la preocupación relacionada con el cáncer (de moderada a muy alta) se observó en el 48% (19/40, IC 95%: 32- 64) de los participantes. El distrés global patológico se identificó en el 25% (10/40, IC 95%: 13- 42) de los sujetos. Un nivel de educación superior (estudios universitarios), la carencia de comorbilidad psiquiátrica a lo largo de la vida y la falta de antecedentes familiares de cáncer se asociaron con una menor ansiedad, distrés global y carcinofobia. CONCLUSIONES: La LBSR combinada con biopsia tipo SINK es una técnica aparentemente factible, segura y podría ofrecer un impacto clínico favorable en el manejo de los TSE de pequeño tamaño. Los TSE ≤10 mm son los mejores candidatos. Casi la mitad de los y las pacientes diagnosticados/as con una lesión subepitelial inespecífica de pequeño tamaño presentan ansiedad-distrés y/o carcinofobia debido a este diagnóstico, detectándose asociaciones específicas como posibles factores de riesgo. El entendimiento de la salud como una esfera transversal de la persona, no sólo de manejo de la patología orgánica, inspiró el planteamiento de la presente Tesis, aportando un abordaje y mirada multidisciplinar

Removal of a migrated biliary stent using new digital cholangioscopy retrieval devices in a transplant patient

A 51-year-old man who had undergone liver transplantation developed a symptomatic anastomotic biliary stricture 23 months after surgery. Endoscopic biliary therapy via endoscopic retrograde cholangiopancreatography (ERCP) was planned. Progressive biliary balloon dilation of the stenosis was performed, with placement of three coaxial plastic stents (8.5-Fr × 12 cm, 8.5-Fr × 9 cm, and 10-Fr × 12 cm; Advanix, Boston Scientific, Natick, Massachusetts, USA). During an endoscopy to replace the stents, fluoroscopy revealed proximal migration of an 8.5-Fr plastic stent at the level of the cystic insertion ([Fig. 1]). Several failed extraction attempts were made using the standard ERCP techniques (i. e. extractor balloon, Lasso technique, and others) [1] [2]. Single-operator peroral intraductal cholangioscopy (SpyGlass DS direct visualization system, Boston Scientific) confirmed impaction of the distal end of the proximally migrated stent, located 3 cm proximally to the duodenal papilla. An attempt to mobilize the migrated stent was made using biopsy forceps (SpyBite, Boston Scientific), without success

Half of the patients with subepithelial tumours present borderline or pathologic anxiety-distress and carcinophobia: multicentre cohort study

Background and aims: minor nonspecific gastrointestinal sub-epithelial lesions (usually defined by the term 'tumor') are usually associated with a malignant illness and cancer. The aim of this study was to assess anxiety-distress and carcinophobia in patients referred to specialized monographic outpatient clinics for evaluation and treatment of this type of lesion.Methods: prospective, multicenter, cohort study. Specific self-reported questionnaires were used to report threat-ening life-experiences and to assess levels of distress (The Hospital Anxiety and Depression Scale) and cancer-related worries (The Cancer Worry Scale).Results: forty participants were included and analyzed at baseline. Pathologic and borderline anxiety were detected in 13 % (5/40, 95 % CI: 4-27 %) and 35 % (14/40, 95 % CI: 21-52 %) of participants, respectively, whereas, cancer-relat-ed worries (moderate to very high) were observed in 48 % (19/40, 95 % CI: 32-64 %) of participants. Pathologic global distress was identified in 25 % (10/40, 95 % CI: 13-42 %) of subjects. Higher educational level (university studies), a lack of lifetime psychiatric comorbidity and a lack of family history of cancer were associated with less anxiety, global distress and carcinophobia.Conclusions: almost half of the patients diagnosed with a minor nonspecific gastrointestinal subepithelial lesion pre-sented anxiety-distress and/or carcinophobia. Specific associ-ations with anxiety-distress reaction and fears were detected

Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS: a randomized controlled trial protocol.

Background: It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven. Methods/design: This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to < 50% or < 5 cm in size), along with clinical improvement. Secondary endpoints: long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences. Discussion: The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON

Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS : A randomized controlled trial protocol

It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven. This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to < 50% or < 5 cm in size), along with clinical improvement. Long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences. The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON. ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home