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3.
Best Pract Res Clin Gastroenterol ; 69: 101897, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38749576

RESUMO

Managing complications of ERCP poses a significant clinical challenge to endoscopists. ERCP complications can occur even after all preventive measures, which can lead to significant morbidity and even mortality. Major complications include pancreatitis, bleeding, perforation, cholangitis, and sedation-related adverse events. Early recognition of post-ERCP pancreatitis (PEP) is feasible by monitoring clinical parameters and specific cutoffs of serum amylase and lipase at 2-6 h post-ERCP. Pancreatic stenting for PEP is not recommended and can increase the incidence of infected necrosis in addition to being technically challenging. Post-sphincterotomy bleeds can be treated by diluted epinephrine with or without thermal therapy, or mechanical therapy (clips or fully covered metallic stents) failing which angiographic embolization and rarely open surgical vessel ligation may be warranted. Post-ERCP perforations can lead to significant morbidity and are usually treated with endoscopic closure of the defect, diverting bile flow, draining collections, and reducing fluid load at the site of perforation failing which surgery may be warranted. Broad-spectrum antibiotics with endoscopic or radiologic drainage of undrained segments help treat post-ERCP cholangitis. Hypoxia and hypertension are the most common sedation-related adverse events without long-term consequences except aspiration pneumonia (<0.5%). Awareness with a high index of suspicion is crucial for timely diagnosis and management of uncommon post-ERCP complications.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Pancreatite , Humanos , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Pancreatite/etiologia , Pancreatite/terapia , Colangite/etiologia , Colangite/terapia , Complicações Pós-Operatórias/terapia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/diagnóstico
4.
Best Pract Res Clin Gastroenterol ; 69: 101906, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38749582

RESUMO

Endoscopic retrograde cholangiopancreatography (ERCP) is a common endoscopic procedure which plays a key role in the management of diseases of the bile ducts and the pancreas. Despite ERCP being performed routinely since more than 4 decades, it is still related to a considerable rate of complications with post-ERCP pancreatitis being the most frequent one. Lately, endoscopic techniques have evolved, and numerous modalities have been developed to prevent or manage ERCP-related complications, especially PEP, such as the use of intra-rectal non-steroidal anti-inflammatory drugs (NSAIDs), insertion of prophylactic stents in the pancreatic duct (PD) or intravenous hyperhydration. Knowledge of the various risk factors and applying validated preventive methods are keys in providing a safe procedure and optimizing overall patient care.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Pancreatite , Stents , Humanos , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Fatores de Risco , Pancreatite/prevenção & controle , Pancreatite/etiologia , Anti-Inflamatórios não Esteroides/uso terapêutico
5.
Gastroenterol Nurs ; 47(2): 101-110, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38567853

RESUMO

The ionizing radiation used during endoscopic retrograde cholangiopancreatography (ERCP) can have harmful effects on patients and staff. The aim of the study was to determine the effect of radiation on nurses working in an ERCP unit. A descriptive, cross-sectional study was completed between June and August 2022 with the voluntary participation of 114 ERCP nurses. The data were collected using WhatsApp messenger through a Google Form. It was determined that, of the nurses, 68.4% received training on radiation safety, all of them took protective measures, 98.2% had knowledge about the effects of radiation, and 93.9% used dosimeters. Nurses stated that they mostly experienced fatigue (94.7%), loss of energy (68.4%), headache (39.3%), hair loss (35.1%), weakness (18%), leg and joint pain (15.1%), thyroid diseases (12.3%), skin discoloration (7.9%), and anemia (7.9%) as the possible effects of radiation during the period they worked in ERCP. The study found that 3.5% of the nurses were diagnosed with cancer while working in the endoscopic retrograde cholangiopancreatography unit. Additionally, ERCP nurses experienced the negative effects of radiation at different rates, but there was no significant relationship between demographic and health characteristics and experiencing the negative effects of radiation.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Humanos , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Estudos Transversais
7.
BMC Gastroenterol ; 24(1): 124, 2024 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-38566038

RESUMO

BACKGROUND: Proper sedation of patients, particularly elderly individuals, who are more susceptible to sedation-related complications, is of significant importance in endoscopic retrograde cholangiopancreatography (ERCP). This study aims to assess the safety and efficacy of a low-dose combination of midazolam, alfentanil, and propofol for deep sedation in elderly patients undergoing ERCP, compared to a group of middle-aged patients. METHODS: The medical records of 610 patients with common bile duct stones who underwent elective ERCP under deep sedation with a three-drug regimen, including midazolam, alfentanil, and propofol at Shandong Provincial Third Hospital from January 2023 to September 2023 were retrospectively reviewed in this study. Patients were categorized into three groups: middle-aged (50-64 years, n = 202), elderly (65-79 years, n = 216), and very elderly (≥ 80 years, n = 192). Intraoperative vital signs and complications were compared among these groups. RESULTS: The three groups showed no significant difference in terms of intraoperative variation of systolic blood pressure (P = 0.291), diastolic blood pressure (P = 0.737), heart rate (P = 0.107), peripheral oxygen saturation (P = 0.188), bispectral index (P = 0.158), and the occurrence of sedation-related adverse events including hypotension (P = 0.170) and hypoxemia (P = 0.423). CONCLUSION: The results suggest that a low-dose three-drug regimen consisting of midazolam, alfentanil, and propofol seems safe and effective for deep sedation of elderly and very elderly patients undergoing ERCP procedures. However, further studies are required to verify these findings and clarify the benefits and risks of this method.


Assuntos
Sedação Profunda , Propofol , Idoso , Pessoa de Meia-Idade , Humanos , Propofol/efeitos adversos , Midazolam/efeitos adversos , Alfentanil/efeitos adversos , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Hipnóticos e Sedativos/efeitos adversos , Sedação Profunda/efeitos adversos , Sedação Profunda/métodos , Estudos Retrospectivos , Sedação Consciente/efeitos adversos , Sedação Consciente/métodos
8.
World J Gastroenterol ; 30(15): 2118-2127, 2024 Apr 21.
Artigo em Inglês | MEDLINE | ID: mdl-38681983

RESUMO

BACKGROUND: During emergency endoscopic retrograde cholangiopancreatography (ERCP), the safety and feasibility of performing one-stage endoscopic treatment for patients with acute cholangitis (AC) due to choledocholithiasis are unclear. AIM: To investigate the safety and feasibility of one-stage endoscopic treatment for moderate to severe AC. METHODS: We enrolled all patients diagnosed with moderate to severe cholangitis due to common bile duct stones from January 2019 to July 2023. The outcomes were compared in this study between patients who underwent ERCP within 24 h and those who underwent ERCP 24 h later, employing a propensity score (PS) framework. Our primary outcomes were intensive care unit (ICU) admission rates, ICU length of stay, and duration of antibiotic use. RESULTS: In total, we included 254 patients and categorized them into two groups based on the time elapsed between admission and intervention: The urgent group (≤ 24 h, n = 102) and the elective group (> 24 h, n = 152). Ninety-three pairs of patients with similar characteristics were selected by PS matching. The urgent ERCP group had more ICU admissions (34.4% vs 21.5%, P = 0.05), shorter ICU stays (3 d vs 9 d, P < 0.001), fewer antibiotic use (6 d vs 9 d, P < 0.001), and shorter hospital stays (9 d vs 18.5 d, P < 0.001). There were no significant differences observed in adverse events, in-hospital mortality, recurrent cholangitis occurrence, 30-d readmission rate or 30-d mortality. CONCLUSION: Urgent one-stage ERCP provides the advantages of a shorter ICU stay, a shorter duration of antibiotic use, and a shorter hospital stay.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Colangite , Coledocolitíase , Estudos de Viabilidade , Tempo de Internação , Pontuação de Propensão , Humanos , Feminino , Masculino , Coledocolitíase/cirurgia , Coledocolitíase/diagnóstico , Coledocolitíase/complicações , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Colangite/cirurgia , Colangite/etiologia , Idoso , Pessoa de Meia-Idade , Tempo de Internação/estatística & dados numéricos , Doença Aguda , Resultado do Tratamento , Estudos Retrospectivos , Índice de Gravidade de Doença , Unidades de Terapia Intensiva/estatística & dados numéricos , Antibacterianos/uso terapêutico , Idoso de 80 Anos ou mais
10.
J Coll Physicians Surg Pak ; 34(4): 413-418, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38576282

RESUMO

OBJECTIVE: To analyse the pertinent risk factors associated with post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) and develop a predictive scoring system for assessing the risk of PEP in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) procedures. STUDY DESIGN: Descriptive study. Place and Duration of the Study: Department of Gastroenterology, Nantong First People's Hospital, Jiangsu, China, from January 2022 to January 2023. METHODOLOGY: Clinical data of 375 patients who underwent successful ERCP treatment were collected and organised. Relevant risk factors for PEP were analysed, and a scoring system was established to predict the risk of PEP. RESULTS: Among the 375 patients who underwent ERCP, the incidence of PEP was 9.07% (34/375). Univariate analysis revealed that female gender, pancreatic duct opacification, difficult cannulation, operation time ≥45 minutes, sphincter of Oddi dysfunction (SOD), and biliary stenting were risk factors for PEP. Multivariate analysis showed that female gender, pancreatic duct opacification, difficult cannulation, operation time ≥45 minutes, and SOD were independent risk factors for PEP. A scoring system was developed, and the receiver operating characteristic (ROC) curve analysis determined a cut-off value of 1.5 points. Patients with a score less than 1.5 points had a low probability of developing PEP, while those with a score greater than 1.5 points had a significantly higher probability of PEP. CONCLUSION: Female gender, pancreatic duct opacification, difficult cannulation, operation time ≥45 minutes, and SOD were independent risk factors for PEP. Additionally, a reliable scoring system was established to predict the risk of PEP. Clinicians can use this scoring system to assess the risk of PEP in patients and implement preventive measures to reduce the incidence of PEP. KEY WORDS: Endoscopic retrograde cholangiopancreatography, Post-ERCP pancreatitis, Risk factors, Risk assessment, Preventive measure.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Pancreatite , Humanos , Feminino , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Ductos Pancreáticos/cirurgia , Fatores de Risco , Pancreatite/epidemiologia , Pancreatite/etiologia , Pancreatite/prevenção & controle , Medição de Risco
12.
Surg Endosc ; 38(4): 2288-2296, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38488871

RESUMO

BACKGROUND: Thin delivery system stents can be inserted directly without the need for a tract dilation step and are expected to reduce bile leakage during endoscopic ultrasound-guided biliary drainage (EUS-BD). The present study retrospectively compared the safety and efficacy of EUS-BD using a thin metal stent (< 7.5 Fr) with those of EUS-BD using a conventional stent (≥ 7.5 Fr). METHODS: The present study enrolled 112 patients who underwent EUS-BD using metal stents for unresectable malignant biliary obstruction between April 2016 and July 2022. The primary endpoint was the rate of adverse events (AEs). The secondary endpoints were clinical success rate, procedure time, procedure success rate in the absence of the tract dilation step, recurrent biliary obstruction rate, time to biliary obstruction, and overall survival. Risk factors associated with early AEs were also evaluated. RESULTS: The rate of early AEs was significantly lower (12% vs. 35%, P = 0.013) and the procedure success without the tract dilation step was significantly higher (82% vs. 33%, P < 0.001) in the thin than in the conventional delivery system stent group. None of the other secondary endpoints differed significantly between the two groups. Multivariate analysis showed that employing the tract dilation step during EUS-BD was a significant independent risk factor for early AEs (skipping vs. employing; HR, 9.66; 95% CI, 1.13-83.0, P = 0.028). CONCLUSION: Employing the tract dilation step during EUS-BD was a significant risk factor for early AEs. Metal stents with a delivery diameter < 7.5 Fr can be inserted directly without the tract dilation step, resulting in lower early AE rates.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Colestase , Humanos , Estudos Retrospectivos , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Dilatação/efeitos adversos , Colestase/etiologia , Colestase/cirurgia , Endossonografia/métodos , Stents/efeitos adversos , Drenagem/efeitos adversos , Drenagem/métodos , Ultrassonografia de Intervenção/efeitos adversos
13.
Cir Cir ; 92(1): 88-95, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38537230

RESUMO

OBJECTIVE: To investigate the value of endoscopic duodenal papillary sphincterotomy combined with balloon dilatation in the treatment of duodenal papilloplasty with titanium clip after choledocholithiasis in post-operative complications. MATERIALS AND METHODS: One hundred and twenty-five patients (69 males and 56 females) with a median age of 65 (32-81) years were included. The treatment plan was randomly divided into Group A (n = 59) and Group B (n = 66) according to the random number table. Patients in Group A were treated with endoscopic sphincterotomy (EST) combined with endoscopic papillary large balloon dilation (EPLBD), followed by a titanium clip for duodenal papilloplasty and then indwelling nasobiliary drainage, whereas those in Group B were treated with EST combined EPLBD to remove stones and then indwelling nasobiliary drainage. RESULTS: In patients with choledocholithiasis or with anatomical changes that make stone extraction difficult, this prospective study attempted to perform duodenal papilloplasty with titanium clips after EST and EPLBD lithotripsy to compare and observe post-operative papillary healing, biliary reflux, and complication rates. CONCLUSIONS: The use of endoscopic duodenal papilloplasty with a titanium clip can improve biliary reflux after lithotripsy and reduce the incidence of post-operative cholangitis complications.


OBJETIVO: Investigar el valor de la esfinterotomía papilar duodenal endoscópica combinada con dilatación con balón en el tratamiento de la papiloplastia duodenal con clip de titanio después de coledocolitiasis en complicaciones postoperatorias. MATERIALES Y MÉTODOS: Se incluyeron un total de 125 pacientes (69 hombres y 56 mujeres) con una mediana de edad de 65 (32-81) años. Los pacientes del Grupo A se trataron con esfinterotomía endoscópica (EST) combinada con dilatación papilar endoscópica con balón grande (EPLBD), seguida de clip de titanio para papiloplastia duodenal y luego drenaje nasobiliar permanente, mientras que los del Grupo B se trataron con EPLBD combinado con EST para eliminar cálculos y luego drenaje nasobiliar permanente. RESULTADOS: En pacientes con coledocolitiasis o con cambios anatómicos que dificultan la extracción de cálculos, este estudio prospectivo intentó realizar papiloplastia duodenal con clips de titanio después de litotricia EST y EPLBD para comparar y observar la cicatrización papilar postoperatoria, el reflujo biliar y las tasas de complicaciones. CONCLUSIÓN: El uso de papiloplastia duodenal endoscópica con clips de titanio puede mejorar el reflujo biliar después de la litotricia y reducir la incidencia de complicaciones de colangitis postoperatorias.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Coledocolitíase , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Coledocolitíase/cirurgia , Coledocolitíase/complicações , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Titânio , Resultado do Tratamento , Adulto , Pessoa de Meia-Idade
14.
Sci Rep ; 14(1): 7341, 2024 03 28.
Artigo em Inglês | MEDLINE | ID: mdl-38538734

RESUMO

Endoscopic Retrograde Cholangiopancreatography (ERCP) is the primary therapeutic procedure for pancreaticobiliary disorders, and studies highlighted the impact of papilla anatomy on its efficacy and safety. Our objective was to quantify the influence of papilla morphology on ERCP outcomes. We systematically searched three medical databases in September 2022, focusing on studies detailing the cannulation process or the rate of adverse events in the context of papilla morphology. The Haraldsson classification served as the primary system for papilla morphology, and a pooled event rate with a 95% confidence interval was calculated as the effect size measure. Out of 17 eligible studies, 14 were included in the quantitative synthesis. In studies using the Haraldsson classification, the rate of difficult cannulation was the lowest in type I papilla (26%), while the highest one was observed in the case of type IV papilla (41%). For post-ERCP pancreatitis, the event rate was the highest in type II papilla (11%) and the lowest in type I and III papilla (6-6%). No significant difference was observed in the cannulation failure and post-ERCP bleeding event rates between the papilla types. In conclusion, certain papilla morphologies are associated with a higher rate of difficult cannulation and post-ERCP pancreatitis.


Assuntos
Ampola Hepatopancreática , Pancreatite , Humanos , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Cateterismo/métodos , Ampola Hepatopancreática/cirurgia , Esfinterotomia Endoscópica/efeitos adversos , Pancreatite/etiologia
15.
World J Gastroenterol ; 30(7): 614-623, 2024 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-38515949

RESUMO

Severe gallstone pancreatitis (GSP) refractory to maximum conservative therapy has wide clinical variations, and its pathophysiology remains controversial. This Editorial aimed to investigate the pathophysiology of severe disease based on Opie's theories of obstruction, the common channel, and duodenal reflux and describe its types. Severe GSP might be a hybrid disease with pathology polarized between acute cholangitis with mild pancreatitis (biliary type) and necrotizing pancreatitis uncomplicated with biliary tract disease (pancreatic type), in which hepatobiliary and pancreatic lesion severity is inversely related to the presence or absence of impacted ampullary stones. Severe GSP is caused by stones that are persistently impacted at the ampulla with biliopancreatic obstruction (biliary type), and probably, stones that are either temporarily lodged at the duodenal orifice or passed into the duodenum, thereby permitting reflux of bile or possible duodenal contents into the pancreas (pancreas type). When the status of the stones and the presence or absence of impacted ampullary stones with biliopancreatic obstruction are determined, the clinical course and outcome can be predicted. Gallstones represent the main cause of acute pancreatitis globally, and clinicians are expected to encounter GSP more often. Awareness of the etiology and pathogenesis of severe disease is mandatory.


Assuntos
Doenças Biliares , Colangite , Cálculos Biliares , Pancreatite , Humanos , Cálculos Biliares/complicações , Cálculos Biliares/terapia , Pancreatite/complicações , Doença Aguda , Doenças Biliares/complicações , Colangite/complicações , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos
16.
World J Gastroenterol ; 30(8): 811-816, 2024 Feb 28.
Artigo em Inglês | MEDLINE | ID: mdl-38516233

RESUMO

Endoscopic ultrasound (EUS) with fine needle aspiration or fine needle biopsy is the gold standard for sampling tissue to diagnose pancreatic cancer and autoimmune pancreatitis or to analyze cyst fluid. The most common reported adverse event of fine needle aspiration and/or fine needle biopsy is acute pancreatitis, which is likely induced by the same pathophysiological mechanisms as after endoscopic retrograde cholangiopancreatography (ERCP). According to the current European Society of Gastrointestinal Endoscopy guideline, nonsteroidal anti-inflammatory drugs are administered prior to ERCP as a scientifically proven treatment to reduce post-ERCP pancreatitis incidence rate. A single suppository of diclofenac or indomethacin prior to EUS guided tissue acquisition (TA) is harmless in healthy adults. Since it is associated with low costs and, most important, may prevent a dreadsome complication, we strongly recommend the administration of 100 mg diclofenac rectally prior to EUS-TA. We will explain this recommendation in more detail in this review as well as the risk and pathophysiology of post-EUS TA pancreatitis.


Assuntos
Pancreatite , Adulto , Humanos , Pancreatite/epidemiologia , Pancreatite/etiologia , Pancreatite/prevenção & controle , Incidência , Diclofenaco/uso terapêutico , Doença Aguda , Anti-Inflamatórios não Esteroides/uso terapêutico , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Ultrassonografia de Intervenção/efeitos adversos , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/efeitos adversos
17.
Folia Med (Plovdiv) ; 66(1): 46-58, 2024 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-38426465

RESUMO

INTRODUCTION: Obstructive jaundice is a clinical syndrome that is commonly seen in gastroenterology. Endoscopic retrograde cholangiopancreatography (ERCP) has been recognized as a first-choice therapeutic approach, with percutaneous biliary interventions (PBIs) being a viable alternative. Recent data questions the performance and safety profile of PBIs.


Assuntos
Sistema Biliar , Endossonografia , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Drenagem
18.
South Med J ; 117(3): 159-164, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38428938

RESUMO

OBJECTIVES: Pancreatic divisum (PD) is the second most common congenital abnormality of the pancreatic duct, which affects 2% to 3% of the population. Most of the population remains asymptomatic, but in people who present with symptoms, it can be a cause of anguish and should be recognized. The main goal of this article was to provide a comprehensive picture of clinical and epidemiological methods of diagnosis and treatment of PD. METHODS: A total of 57 PD case reports were considered in this descriptive analysis with 51 case reports and case series published within the last 25 years. The search strategies include systemic searches using scholarly search engines such as Medscape, Scopus, Cochrane, and PubMed. RESULTS: The 57 cases we studied have an average age of presentation of 42 years, with female sex (58%) predominance. Common presenting symptoms were abdominal pain (87.72%) and radiation to the back (21.6%). Eighty-one percent of the case studies reported pancreatitis, and 63.2% had recurrent pancreatitis. At presentation, laboratory values demonstrated increased amylase, lipase, and liver enzymes. PD was diagnosed using magnetic resonance cholangiopancreatography (28.1%), endoscopic retrograde cholangiopancreatography (57.9%), endoscopic ultrasound (7%), or computed tomography (5.3%) scan of the abdomen. Of significance, biliary duct dilation was found in 70.6% of patients diagnosed as having PD. Incidental masses were found in 66.7% of the patients. The most successful treatment was sphincterotomy with or without stents (47.6%), followed by pancreatoduodenectomy (19%) and pancreaticojejunostomy (10%). CONCLUSIONS: Physicians managing pancreatitis should add PD to their differential diagnoses because it will help improve patient outcomes and avoid unfavorable consequences.


Assuntos
Pâncreas Divisum , Pancreatite , Humanos , Feminino , Adulto , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Pancreatite/diagnóstico , Pancreatite/epidemiologia , Pancreatite/terapia , Ductos Pancreáticos/anormalidades , Dor Abdominal/etiologia
19.
Pancreatology ; 24(3): 363-369, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38431445

RESUMO

OBJECTIVE: Hemin, a heme oxygenase 1 activator has shown efficacy in the prevention and treatment of acute pancreatitis in mouse models. We conducted a randomized controlled trial (RCT) to assess the protective effect of Hemin administration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in patients at risk. METHODS: In this multicenter, multinational, placebo-controlled, double-blind RCT, we assigned patients at risk for PEP to receive a single intravenous dose of Hemin (4 mg/kg) or placebo immediately after ERCP. Patients were considered to be at risk on the basis of validated patient- and/or procedure-related risk factors. Neither rectal NSAIDs nor pancreatic stent insertion were allowed in randomized patients. The primary outcome was the incidence of PEP. Secondary outcomes included lipase elevation, mortality, safety, and length of stay. RESULTS: A total of 282 of the 294 randomized patients had complete follow-up. Groups were similar in terms of clinical, laboratory, and technical risk factors for PEP. PEP occurred in 16 of 142 patients (11.3%) in the Hemin group and in 20 of 140 patients (14.3%) in the placebo group (p = 0.48). Incidence of severe PEP reached 0.7% and 4.3% in the Hemin and placebo groups, respectively (p = 0.07). Significant lipase elevation after ERCP did not differ between groups. Length of hospital stay, mortality and severe adverse events rates were similar between groups. CONCLUSION: We failed to detect large improvements in PEP rate among participants at risk for PEP who received IV hemin immediately after the procedure compared to placebo. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov number, NCT01855841).


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Pancreatite , Animais , Humanos , Camundongos , Anti-Inflamatórios não Esteroides/uso terapêutico , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Heme Oxigenase-1 , Hemina/uso terapêutico , Lipase , Pancreatite/etiologia , Pancreatite/prevenção & controle , Administração Intravenosa
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