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Cholecystitis, Acute clinical trials

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NCT ID: NCT06364865 Not yet recruiting - Acute Cholecystitis Clinical Trials

AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study

AE05ML
Start date: April 22, 2024
Phase:
Study type: Observational [Patient Registry]

This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback.

NCT ID: NCT06287112 Not yet recruiting - Acute Cholecystitis Clinical Trials

Prevention of Acute Cholecystitis With ETGBD

Start date: March 2, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion. In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility.

NCT ID: NCT06228027 Not yet recruiting - Acute Cholecystitis Clinical Trials

External Validation os the ACME Scoring System

ACME_2
Start date: January 1, 2025
Phase:
Study type: Observational [Patient Registry]

Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is surgical treatment (ST) and the accepted mortality is <1%, but in severe and/or fragile patients is higher. Despite the Tokyo Guidelines, there no consensus on who is the unfit patient for ST. A recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (ACME) and could help to develop new guidelines in ACC. The aim of this study is to perfom an external validation of the new simplified scoring system for mortality in ACC.

NCT ID: NCT06011941 Not yet recruiting - Clinical trials for Common Bile Duct Calculi

Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques. Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube. Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube. Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.

NCT ID: NCT05502744 Not yet recruiting - Clinical trials for Cholecystitis, Acute

Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy.

Start date: August 14, 2022
Phase: N/A
Study type: Interventional

The aim of study is compare outcome of patients undergoing early laparoscopic cholecystectomy within 72 hours from the begging of symptoms to those of patients managed conservatively and operated late after 6-8weeks after the inflammatory reaction has subsided.

NCT ID: NCT05484232 Not yet recruiting - Clinical trials for Acute Calculous Cholecystitis

Outcomes of Early Laparoscopic Cholecystectomy in Cases of Acute Cholecystitis

Start date: August 2022
Phase: N/A
Study type: Interventional

Laparoscopic cholecystectomy is the most common laparoscopic surgery performed in the world. The initial treatment of acute calculus cholecystitis includes GIT rest, intravenous fluid, correction of electrolyte imbalance from repeated vomiting, good analgesia, and intravenous antibiotics. Following this treatment, patients with uncomplicated disease are managed on outpatient basis and are called for elective laparoscopic cholecystectomy after a period of 6-8 weeks. Elective laparoscopic cholecystectomy has become the gold standard for treatment of symptomatic gallstones. However, in the early days, acute cholecystitis was a contraindication of laparoscopic cholecystectomy, and patients with acute cholecystitis were managed conservatively and discharged for re-admission in order to have elective surgery performed for the definitive treatment. Early laparoscopic cholecystectomy, within 72 hours of presentation,has been advocated because of shorter hospital stay, decreased financial costs and reduced readmission rates. Previously cited reasons against early laparoscopic cholecystectomy include the increased technical difficulties, increased risk of conversion to an open procedure (6-35 % in some studies) and increased risks of biliary complications such as bile leaks and common bile duct (CBD) injuries when operating on an inflamed gallbladder with edematous planes and distorted anatomy.

NCT ID: NCT05339282 Not yet recruiting - Clinical trials for Cholecystitis, Acute

Effectiveness of Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

This clinical trial is an exploratory clinical trial that evaluates the necessity and effectiveness of empirical antibiotic use in mild and moderate acute inflammatory gallbladder diseases that require surgery, and the incidence of postoperative infection-related complications is compared.

NCT ID: NCT04922528 Not yet recruiting - Choledocholithiasis Clinical Trials

Visualization of the Extrahepatic biliaRy Tree Trial

VERT
Start date: August 2021
Phase: N/A
Study type: Interventional

This study is a prospective randomized controlled trial evaluating the use of a fluorescent dye, indocyanine green (ICG), in the identification of important bile duct anatomy during emergent same-admission cholecystectomy. Participants will be randomized into either the control arm, which uses the standard of care white light during laparoscopy or the intervention arm, which will use ICG fluorescent cholangiography as an adjunct to white light to visualize the biliary anatomy. The investigators hypothesize that the use of fluorescent cholangiography will increase the rates of identification of important biliary anatomy during laparoscopic cholecystectomy. The effectiveness, feasibility, and safety will be compared between the two groups using a post-operative survey form the surgeons will complete prior to exiting the operating room.

NCT ID: NCT04739891 Not yet recruiting - Choledocholithiasis Clinical Trials

Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors

CHOLEPREV
Start date: February 15, 2021
Phase:
Study type: Observational

The management of cholelithiasis with choledocolithiasis is extensively known, whereas for Acute Calculous Cholecystitis (ACC) with choledocolithiasis or common bile duct stones (CBDS), a common entity, there is a lack of protocols for optimising treatment. The main hypothesis of our study is: a correct stratification of the concomitant CBDS probability at ACC diagnosis would optimize its treatment as early targeted treatment could be performed. One-step management of ACC with CBDS by a specialised hepatobiliary team would represent a benefit to the patient in terms of morbi-mortality, admission time and number of admissions. The aim of our study is to identify high / intermediate probability criteria for CBDS associated when diagnosing CA. This is a retrospective study of patients who were operated on with an emergent cholecystectomy in our center from 01/2012 to 12/2019.

NCT ID: NCT04661371 Not yet recruiting - Clinical trials for Cholecystitis, Acute

Necessity of Preoperative Empirical Antibiotic Use in Acute Cholecystitis

Start date: March 2, 2021
Phase: N/A
Study type: Interventional

In this study, the investigators compared the surgical outcomes according to the type of antibiotics before surgery in patients who did not have evidence of systemic infection during acute cholecystitis. The primary purpose of the study was to determine the type of preoperative antibiotics in patients who were scheduled for cholecystectomy, because of the mild (grade I) or moderate (grade 2) acute inflammatory gallbladder disease without gallbladder perforation. The investigators compared the incidence of postoperative complications according to the types of preoperative antibiotics(the first-generation vs second-generation cephalosporin). The secondary purpose of the study was to confirm the clinical efficacy of first-generation cephalosporins following the use of empirical antibiotics. And the investigators compare with postoperative pain, postoperative hospital stay, re-hospitalization, and need for additional treatment. In addition, the investigators compare the postoperative complications, such as atelectasis and postoperative ileus.