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Gallstones clinical trials

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NCT ID: NCT05723224 Recruiting - Cholecystolithiasis Clinical Trials

Elective Endoscopic Gallbladder Treatment: Pilot Study

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

Laparoscopic cholecystectomy (LC) represents the gold standard for treatment of elective and acute of gallbladder diseases, such as acute cholecystitis (AC). However, in elderly patients or in those with severe comorbidities, urgent LC can be associated with increase morbidity (up to 41%) and mortality (up to 19%). In these patients, placement of a percutaneous gallbladder drainage catheter (PT-GBD) or colecistostomy can be utilized to drain the gallbladder until infection is resolved, as a bridge to subsequent surgery or as definitive treatment. PT-GBD, however, is associated with major adverse events (AEs): intra-hepatic hemorrhage, pneumothorax, biliary peritonitis, bile leak from the site of drainage, AC recurrency, self-removal of the drainage by the patient e/o for spontaneous migration. Recently, to overcome PT-GBD limitations, EUS-guided gallbladder drainage (EUS-GBD) has been introduced as an alternative minimally invasive therapeutic intervention for treatment of patients with high surgical risk who present with AC. The procedure has high technical and clinical success rates and favorable safety profile, with low risk of recurrent AC. EUS-GBD, followed, when needed, by intra-cholecystic endoscopic interventions has been utilized even in relatively young patients as recently reported with successful intra-cholecystic giant stones clearance through the LAMS using previously described endoscopic lithotripsy in patients who rejected surgery and desired gallbladder preservation. A second category of patients who might benefit from EEGBT are elderly individuals with major comorbidities posing them at high surgical risk, who suffer from previous episodes of cholecystitis, recurrent colic episodes due to gallbladder stones, or with biliary acute pancreatitis due to stones migration. Based on all the above considerations, we have designed a prospective, pilot study to evaluate the safety and efficacy of elective EEGBT performed using LAMS stent with electrocautery-enhanced delivery system, followed by intra-cholecystic endoscopic interventions when needed in elderly patients with benign gallbladder diseases at high surgical risk, in whom an indication to perform cholecystectomy was indicated.

NCT ID: NCT05704907 Not yet recruiting - Gallstone Clinical Trials

Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones

DUAL-GB
Start date: February 2023
Phase: N/A
Study type: Interventional

To assess diagnostic performance of Dual Energy CT fo gallblader gallstone detection.

NCT ID: NCT05695989 Completed - Clinical trials for Bariatric Surgery Candidate

Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures

MARS GI
Start date: January 19, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)

NCT ID: NCT05689255 Recruiting - Bile Duct Diseases Clinical Trials

Gut Microbiome and Metabolome in Patients With Gallstone Disease After Surgical and Endoscopic Interventions

Start date: December 23, 2022
Phase:
Study type: Observational

The goal of this longitudinal observational cohort study is to examine the changes in the composition and diversity of gut microbiome and systemic metabolome in patients with symptomatic gallbladder stones with or without concomitant common bile duct (CBD) stones who will be undergoing cholecystectomy with or without prior endoscopic sphincterotomy (ERCP-ES) and CBD stones extraction. The main questions it aims to answer are whether there are: - differences in gut microbiome diversity and composition before and after cholecystectomy - differences in systemic metabolome before and after cholecystectomy - gut microbiome and systemic metabolome changes after cholecystectomy Participants will be asked to provide stool, urine, plasma and saliva samples prior to and 1-6 months after cholecystectomy. For patients with concomitant CBD stones who undergo ERCP-ES before cholecystectomy, bile specimens will be collected from the bile duct during ERCP-ES as well as the gallbladder and/or during cholecystectomy.

NCT ID: NCT05676892 Not yet recruiting - Clinical trials for Cholecystitis/Cholelithiasis

Effects of Intravenous Ibuprofen on Acute Pain After Laparoscopic Cholecystectomy

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

This clinical trial is a medical intervention study to evaluate the necessity and effectiveness of intravenous ibupropan for postoperative acute pain relief after laparoscopic cholecystectomy in benign gallbladder disease. Comparison and evaluation of changes in pain scores after surgery according to the presence or absence of use.

NCT ID: NCT05639816 Completed - Clinical trials for Common Bile Duct Calculi

Effect of Common Bile Duct Stone Clearance Using Saline Irrigation After Stone Removal: A Prospective Randomized Control Trial.

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Retained CBD stone after ERCP is a common problem in clinical practice. This study aimed to evaluate the effect of saline irrigation of common bile duct after complete stone removal considered by ERCP in the reduction of residual CBD stone and the effect on clinical outcome.

NCT ID: NCT05618626 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Prevention of NAFLD and CVD Through Lifestyle Intervention

MAUCO+
Start date: September 27, 2021
Phase: N/A
Study type: Interventional

Prevention of non-alcoholic fatty liver disease (NAFLD) and cardiovascular disease (CVD) through lifestyle intervention (MAUCO+) is a clinical trial that aims to improve sarcopenia, aerobic capacity, body composition, and lipid profile, insulin resistance, cardiovascular risk, NAFLD, and maintain a healthier lifestyle. Through the implementation of physical activity and nutritional programs.

NCT ID: NCT05592795 Active, not recruiting - Choledocholithiasis Clinical Trials

Explore the Effects and Mechanisms of ERCP and EST on Biliary Microecology

Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

The objective of this observational study is to explore the structure of biliary flora in normal people, explore the dynamic impact of ERCP and EST on biliary microecology, study the marker flora, metabolites and functional genes related to biliary diseases, explore the occurrence and development mechanism, regulatory pathways and key targets of biliary diseases, and provide new strategies for the prevention and treatment of biliary diseases from the perspective of biliary microecology.

NCT ID: NCT05579444 Terminated - Obesity Clinical Trials

Systems Biology of Gastrointestinal and Related Diseases

Start date: November 11, 2022
Phase:
Study type: Observational

This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.

NCT ID: NCT05557669 Recruiting - Metabolic Syndrome Clinical Trials

Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

Start date: February 17, 2021
Phase: N/A
Study type: Interventional

Prospective cohort study. POPULATION: patients with gallstone disease qualified for laparoscopic cholecystectomy INTERVENTION: patients undergoing cholecystectomy for gallstones COMPARISON: gallstone disease without surgery in an observation period OUTCOME: metabolic syndrome symptoms evaluated in 3 months period The main inclusion criteria is cholelithiasis confirmed by ultrasound examination in patients between 18-75 years old. The main exclusion criteria are metabolic syndrome, diabetes, thyroid diseases, pancreatic diseases, serious abdominal surgeries in the past, pregnancy, and lactation. Participants who qualified for laparoscopic cholecystectomy in 3 months are included in the investigation group. Those not having cholecystectomy planned in the upcoming three months for any reason (no consent for surgery, long term) are included in the control group. The intervention is to assess all metabolic syndrome criteria (blood pressure, glucose tolerance, dyslipidemia, abdominal obesity) before and three months after surgery. The endpoint is to evaluate if the risk of metabolic syndrome after cholecystectomy is higher than in patients with gallstones.