Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction - BAMPI TRIAL: an open-label, randomized controlled trial protocol

Background It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction. Methods/design This is a multicenter open-label, randomized controlled trial with two parallel groups. Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain and will be randomized to the LAMS and LAMS plus DPS groups. The primary endpoint is the rate of recurrent biliary obstruction, as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate). Discussion The BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting DPS through LAMS is superior to LAMS alone to prevent stent dysfunction

Comparison between insufflation with air or carbon dioxide during the colonoscopy in sedated patients with propofol Comparación entre la insuflación con aire ambiente o con dióxido de carbono durante la colonoscopia en pacientes sedados con propofol

Objectives: compare the intensity of pain experienced after colonoscopy with air or with CO2 and evaluate the safety of CO2 in colonoscopies performed with moderate/deep sedation. Materials and methods: individuals undergoing ambulatory colonoscopy without exclusion criteria (severe respiratory disease, morbid obesity) were randomized in air or CO2 group. We recorded different variables prior to, during and upon completion of the colonoscopy, performing monitoring using pulse oximetry and capnography. Each patient rated, using a visual numeric scale, the intensity of post-colonoscopy pain at different moments. Results: 141 individuals in the air group (sex M/F 63/78, age 24-83) and 129 in the CO2 group (sex M/F 59/70, age 24-82). No significant differences existed in the recorded variables in both groups except for the greater number of explorations performed by an endoscopist in training (TE) in the air group compared to those by a more experienced endoscopist (SE). CO2 in expired air, episodes of oxygen desaturation and of apnoea and dose of propofol, of midazolam were similar in both groups. No episodes of hypercapnea or any complication requiring cardiopulmonary resuscitation measures were recorded. The pain in the air group was significantly higher at 15 minutes and at 1, 3 and 6 hours after the endoscopy, equalising at 24 hours. After multivariant adjustment for type of doctor (TE vs. SE) the differences observed in pain intensity for each group were maintained. Conclusions: a) the use of CO2 in colonoscopy causes significantly less pain in the first 6 hours after the procedure; b) its use in patients with moderate/deep sedation is safe; and c) performance of the endoscopic technique is not modified, nor are times reduced.Objetivos: comparar la intensidad del dolor experimentado tras una colonoscopia con aire ambiente o con dióxido de carbono (CO2) y evaluar la seguridad del CO2 en pacientes con sedación moderada o profunda. Materiales y métodos: individuos sometidos a una colonoscopia ambulatoria, sin enfermedad respiratoria severa ni obesidad mórbida, randomizados a grupo "aire" o "CO2". Se recogieron diferentes variables antes, durante y tras la colonoscopia. Todos los pacientes fueron monitorizados mediante capnografía y pulsioximetría. Posteriormente cada paciente puntuó mediante una escala visual numérica la intensidad del dolor experimentado en diferentes momentos tras la colonoscopia. Resultados: 141 pacientes incluidos en grupo "aire" (hombres/ mujeres 63/78, rango edad 24-83) y 129 en "CO2" (hombres/mujeres 59/70, rango edad 24-82). No existieron diferencias significativas entre ambos grupos a excepción del mayor número de exploraciones realizadas por un endoscopista en formación en el grupo "aire" en comparación con las realizadas por endoscopistas experimentados. El CO2 en aire espirado, los episodios de desaturación de oxígeno y las dosis de propofol o midazolam empleadas fueron similares en ambos grupos. No existieron episodios de hipercapnia severos ni complicaciones clínicamente relevantes. El dolor experimentado en el grupo "aire" fue significativamente mayor a los 15 minutos, 1, 3 y 6 horas tras la colonoscopia, igualándose a las 24 horas. Tras la realización de un análisis multivariante según el tipo de endoscopista (experimentado o en formación) las diferencias observadas en la intensidad del dolor en cada grupo se mantuvieron. Conclusiones: a) el uso de CO2 en la colonoscopia causa significativamente menos dolor en las siguientes 6 horas; b) su uso en pacientes con sedación moderada o profunda es seguro; y c) la realización de la técnica no se ve modificada ni sus tiempos reducidos

Endoscopic ultrasound versus multidetector computed tomography in preoperative gastric cancer staging

Introduction: Endoscopic ultrasonography (EUS) is the gold standard technique in loco-regional staging of gastric adenocarcinoma (GAC). Nevertheless, the introduction of multidetector-row computed tomography (MDCT) allows accurate studies to be performed. Objective: To compare the diagnostic yield of EUS and MDCT in loco-regional preoperative staging of gastric adenocarcinoma. Material and methods: This was a retrospective and comparative study of all surgical patients with GAC and preoperative staging by EUS and 64-row MDCT. The results for each case were compared with the histological data. Results: Seventy seven surgical patients with GAC were identified and forty two had a complete preoperative staging and were finally included in the study. With regard to overall accuracy of T staging, EUS was superior to MDCT (62% vs 50%). In a subanalysis of early stages (T1-T2) and advanced stages (T3-T4), accuracy and sensitivity (S) were higher for EUS than for MDTC (83.3% vs 64.29% and 84.4% vs 59.5% respectively), although this did not reach statistical significance. The overall accuracy and sensitivity of EUS for N staging was lower than that for MDCT, although neither comparison reached statistical significance (57% vs 64% and 29% vs 55%). Conclusions: EUS diagnostic yield is similar to new MDCT with regard to T and N preoperative staging of GAC. Nevertheless, both techniques should be considered as complementary until more extensive and randomized studies can confirm these results