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Cholecystitis, Acute clinical trials

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NCT ID: NCT04979936 Completed - Acute Cholecystitis Clinical Trials

Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy in Grade II Acute Cholecystitis Guidelines

PC
Start date: January 1, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to compare between early laparoscopic cholecystectomy versus percutaneous cholecystostomy followed by delayed interval laparoscopic cholecystectomy as regards the operative and postoperative complications

NCT ID: NCT04874103 Completed - Clinical trials for Cholecystitis, Acute

Hong Kong Follow up Protocol After EUS Gallbladder Drainage for Acute Cholecistitis

Start date: May 6, 2020
Phase:
Study type: Observational

This study evaluates the long-term safety and efficacy of the Hong Kong follow up protocol in patients who will undergo drainage of the gallbladder under endoultrasonography (EUS) guidance in patients with acute cholecistitis not suitable for surgery.

NCT ID: NCT04744441 Completed - Clinical trials for Acute Calculous Cholecystitis

Mortality Risk Estimation in Acute Calculous Cholecystitis: Beyond the Tokyo Guidelines

ACME
Start date: January 2011
Phase:
Study type: Observational

Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments, the complication rate of ACC is 20-55%, and the mortality rate is 0.5-15% in recent series. The Tokyo Guidelines (TG) advocate for different initial treatments of ACC with no clear evidence that all patients will benefit from them. The objective of the study is to identify the risk factors for mortality in ACC and compare them with TG classification. It is a retrospective cohort study conducted from January 2011 to December 2016 in a single center with a dedicated surgical emergency unit in a Metropolitan University Hospital in Barcelona, Spain. The analysis of the data was finished in March 2020. The study candidates comprised 963 consecutive patients with a diagnosis of ACC according to the TG18 and/or received a diagnosis of ACC in the Pathology report in those that an emergent cholecystectomy was performed. The study case definition was a 'Pure Acute Cholecystitis' (pure ACC); therefore, patients with any other concomitant diagnosis potentially influencing outcome (Postoperative cholecystitis, Acute Cholangitis, Acute Pancreatitis, Incidental Cholecystectomy, Acalculous Cholecystitis, Chronic Cholecystitis/Persistent Colic, Post-endoscopic retrograde pancreato-cholangiography, or Neoplasia) were excluded from the final analysis. Variables: Primary data were available from a prospective database maintained in File Maker v.12 (Mountainview, CA, USA), which included basic demographic data, type of interventions, sex, days of admission, and complications. Every record was completed by browsing the electronic patient record, adding laboratory and microbiology data, as well as antibiotic therapy, duration of procedure, additional procedures, and grade of acute cholecystitis according to the TG18 diagnostic criteria. Preoperative comorbidities were assessed using the Charlson Comorbidity Index and surgical risk by ASA classification. The type of initial treatment was classified as Surgical Treatment (Cholecystectomy either by laparoscopy or laparotomy) or Non-Surgical Treatment, which was either percutaneous cholecystostomy or intravenous antibiotics alone. The main outcome measure was the mortality after the diagnostic of ACC. In the patients that were discharged, 30 days after the diagnosis, if the patients was not discharged in 30 days, at any time during the same admission. Interventions: All patients received intravenous antibiotic therapy from the moment the diagnosis was formulated, according to a fixed protocol. Ultrasound-guided cholecystostomy was performed percutaneously with an 8-Fr catheter (SKATER ™, Argon Medical Devices, Rochester, NY, USA) by either transhepatic or transperitoneal insertion, at the discretion of the radiologist. Laparoscopic Cholecystectomy was performed according to the French technique using 4 trochars. The content of the gallbladder was evacuated by Veress needle puncture when necessary. Statistical Analysis: The normal distribution of the quantitative variables was assessed using the Kolmogorov-Smirnov test, which showed that none of the variables were normally distributed; therefore, their values were expressed as median and interquartile ranges. The Mann-Whitney U non-parametric test was used to assess the significance of differences between means. The association between qualitative variables was assessed with the chi-square test or Fisher's exact test, as required. The increased risk of an event associated with a variable was reported as the odds ratio (OR) and 95% confidence interval (CI). As this was a retrospective observational study and the treatment groups were markedly asymmetric, we used the propensity score matching method to select and compare two subgroups of patients evenly balanced by severity according to the TG18 criteria and by comorbidity according to the Charlson Comorbidity Index. A model for predicting mortality was built using binomial logistic regression with stepwise progressive conditional entry and standard baseline conditions for admission and rejection of variables with significant differences in the univariate analysis. The discrimination power of the model was assessed by receiver operating characteristic (ROC) curves and was compared with the DeLong method. Legal and Ethical considerations This study was approved by the clinical research ethical committee of the Hospital del Mar and was classified as a non-clinical trial.

NCT ID: NCT04672902 Completed - Cholelithiasis Clinical Trials

Treatment of Mirizzi Syndrome

Start date: November 1, 2020
Phase:
Study type: Observational

Mirizzi syndrome is an infrequent complication of long-standing cholelithiasis. Extrinsic compression of the common hepatic duct is usually caused by an impacted stone in Hartmann's pouch or cystic duct resulting in the development of cholecystobiliary fistula. This syndrome is classified based on the presence and severity of cholecystobiliary fistula. Mirizzi syndrome is challenging to diagnose preoperatively and may require complex biliary surgical procedures for resolution. Endoscopic treatment is a safe alternative with a high success rate. Single-operator cholangioscopy combined with lithotripsy has been shown to have a 90-100% success rate in the treatment of biliary stones. Herein, A single center experience treating Mirizzi syndrome with single-operator cholangioscopy guided electrohydraulic lithotripsy is presented. Difficult management of Mirizzi syndrome has led to research of new treatment options to minimize the risk of high rate complications. Single-operator cholangioscopy in combination with laser lithotripsy is an adequate and safe alternative for the treatment of this condition.

NCT ID: NCT04596306 Completed - Acute Cholecystitis Clinical Trials

Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: A Retrospective Study.

Start date: January 1, 2020
Phase:
Study type: Observational

With the progressive aging of the population in industrialized countries, acute calculous cholecystitis (ACC) has been constantly increasing among elderly. Because ACC is the most common complication of biliary gallstone disease and the population will become older, ACC in elderly is expected to increase. In 2017, the incidence of gallstone disease in Italian population is was 18.8% in women and 9.5% in men; the prevalence was 15% and 24% at 70 years and 24% and 35% at 90 years for males and females respectively. Since the increase in age is often associated with an increase in comorbidity, fragility, surgery related complications, morbidity and mortality, the surgical indication for gallstone is still debated and often based on anesthetic risk. In order to avoid surgery for elderly and high-risk patients, alternative treatments to surgery have been developed. The present study aimed to compare two groups of patients with acute calculous cholecystitis undergone laparoscopic cholecystectomy, under and over 70 years old and to assess whether laparoscopy can offer the same safety and efficacy to older people.

NCT ID: NCT04511910 Completed - Clinical trials for Cholecystitis, Acute

How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score

CholeRiskScore
Start date: January 1, 2013
Phase:
Study type: Observational

Acute calculous cholecystitis (ACC) is the most common complication of gallstone disease, and laparoscopic cholecystectomy is the gold standard treatment. Several prospective studies have demonstrated that same-admission, early LC (ELC), for ACC is safe when compared with delayed LC (DLC). However, there is still controversy on the indication of ELC in high risk patients with important comorbidities, in cases of severe inflammation of the gallbladder and in patients with ACC and suspicious of a choledocholithiasis. The advantages of ELC in high risk patients with severe comorbidities have been recently questioned, with Tokyo Guidelines 2018 (TG18) proposing an initial conservative management of this cases, assessing the benefit of ELC according to specified criteria. However, the recent CHOCOLATE trial, demonstrated the advantages of ELC over an initial conservative management. Performing an ELC for ACC can be a straightforward procedure for an on-call general surgeon or a very challenging procedure even for experienced hepatopancreaticobiliary (HPB) laparoscopic surgeon, depending on disease features, surgeons experience, centres volumes and resources available. Deciding whether the ELC should be performed by the on-call team or by HPB surgical team, or whether the operation should be delayed are still matter of debate in daily practice. Several preoperative scores assessing the risk of difficult cholecystectomy have been proposed, but they were mainly focused on elective procedures and on risk of conversion to open cholecystectomy or other intraoperative complications. They did not asses the risk of post-operative complications in a subgroup of patients, for whom, indication to ELC by the on-call general surgeon is still questionable according to the more recent guidelines.

NCT ID: NCT04405713 Completed - Acute Cholecystitis Clinical Trials

Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis

ACC
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

The ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy

NCT ID: NCT04346550 Completed - Pain Clinical Trials

Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain

Start date: October 2, 2017
Phase: N/A
Study type: Interventional

The purpose of this study was to compare the frequency of pain and mean hospital stay in patients with and without drain insertion, following laparoscopic cholecystectomy for acutely inflamed gallbladder.

NCT ID: NCT04308265 Completed - Acute Cholecystitis Clinical Trials

Scoring System in Acute Calculous Cholecystitis

Start date: March 7, 2020
Phase:
Study type: Observational

Acute cholecystitis is a common disease in the daily practice of general surgery. There are various methods in the treatment of this disease, such as early cholecystectomy, medical treatment, six weeks later cholecystectomy and cholecystostomy. However, it is not satisfied with objective criteria that these methods are selected according to which patient groups. With this observational-prospective study, the benefit of first visit scoring on 'which of the treatment options will be most suitable for the patient' will be investigated. Thus, rare but severe complications of cholecystectomy can be prevented.

NCT ID: NCT04213092 Completed - Clinical trials for Choledocholithiasis With Cholecystitis With Obstruction

Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis

Start date: November 2012
Phase:
Study type: Observational

The ideal management of cholecysto-choledocholithiasis is an open cholecystectomy (OC) with the common bile duct (CBD) exploration worldwide. The single setting 2-stage approach- endoscopic retrograde cholangiopancreatography (ERCP), endoscopic sphincterotomy (EST), and CBD clearance followed by laparoscopic cholecystectomy (LC) offers an advantage, mainly by reducing the hospital stay, the cost, and the morbidity. Investigators did a prospective study in patients admitted for the management of the cholecysto-choledocholithiasis in the Department of Surgery at the Lumbini Medical College and Teaching Hospital from November 2012- October 2015. They underwent 2-stage ERCP+LC in a single setting and investigators compared them with 2-stage OC+CBD exploration in a single setting approach. The patients with the open procedure were the investigator's control groups. All the included cases in the study were elective.