Clinical Trials Logo

Gallstones clinical trials

View clinical trials related to Gallstones.

Filter by:

NCT ID: NCT04924868 Not yet recruiting - Clinical trials for Acute Pancreatitis Due to Gallstones

Ursodeoxycolic Acid for the Prevention of Relapsing Complications After Gallstone Acute Pancreatitis

OSOPOLAR
Start date: July 1, 2021
Phase: Phase 3
Study type: Interventional

Acute pancreatitis is a common disease (3rd cause of hospital admission for digestive causes), which is associated with significant patient suffering, a 2-4% probability of death and considerable healthcare costs. Sixty percent of acute pancreatitis are due to the presence of stones in the gallbladder. The risk of suffering another acute biliary pancreatitis (ABP, that is to say, pancreatitis due to gallstones) or of other biliary complications in the following weeks or months is high (20% or greater) if measures are not taken to avoid it, being surgical removal of the gallbladder the most effective. Unfortunately, most Spanish centers have a surgical waiting list that makes gallbladder surgery unfeasible in a period of less than weeks or months, which is why readmission for biliary problems derived from the stones is a common problem. This, of course, causes danger and great stress and anger for patients affected by these complications on the waiting list, damaging their relationship with the health system and it is linked to increased cost. In addition, there is a very vulnerable group, those patients who due to age or serious diseases cannot undergo gallbladder surgery but have a high probability of suffering biliary problems due to the stones they have. Ursodeoxycholic acid (UDCA) is very safe drug which is used to dissolve gallstones, but its role in preventing biliary complications after ABP has not been studied adequately so it is not frequently used. Our objective is to investigate if UDCA is useful in this scenario, which would avoid suffering and adverse consequences for the patient and reduce the consumption of resources.

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: NCT04915651 Recruiting - Cholecystitis Clinical Trials

Gallbladder Cryoablation in High-Risk Patients

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

Benign gallbladder disease, including acute cholecystitis, chronic cholecystitis, biliary dyskinesia, and biliary colic, is very common, with over 300,000 surgical cholecystectomies performed per year in the US. Unfortunately, complication rates in elderly patients or patients with many comorbidities are high. These patients are often managed with percutaneous tube drainage of the gallbladder (percutaneous cholecystostomy). The recurrence rate of calculous cholecystitis after cholecystostomy tube removal is as high as 35% at 1 year. These patients are thus faced with permanent cholecystostomy tube drainage, high-risk surgery, or cholecystostomy tube removal and risk of repeat cholecystitis. Gallbladder cryoablation is an alternative to surgical cholecystectomy which is performed percutaneously and does not require general anesthesia. Published evidence on the outcomes of gallbladder cryoablation is however limited at this point in time. The purpose of the proposed study is to follow the outcomes of high-risk patients who undergo gallbladder cryoablation.

NCT ID: NCT04908826 Recruiting - Choledocholithiasis Clinical Trials

Comparison of Icg's Route of Administration During Laparoscopic Cholecystectomy

Start date: January 3, 2022
Phase: N/A
Study type: Interventional

The aim of the trial is to compare the routes of administration of indocyanine green (ICG) during laparoscopic cholocystectomy.

NCT ID: NCT04879459 Completed - Gallstone Clinical Trials

Impact on Diagnostic Accuracy of a Specific Clinical Ultrasound Practical Teaching

RCTpCUS
Start date: October 12, 2021
Phase:
Study type: Observational

This research proposal is a pilot double-blind randomized control trial evaluating the impact on diagnostic accuracy of a Clinical UltraSound (CUS) teaching for gallbladder assessment using exclusively healthy volunteers for practical sessions. Classically, a number of 25 to 50 CUS of the gallbladder is reported to achieve competency. Many CUS curricula or guidelines recommend reporting pathological cases, either a certain amount, either generically, in their core-ultrasound competency requirements. Using healthy volunteers is rarely meant to verify the hypothesis that practical sessions based on exclusively normal patterns combined with presentation of pathological ultrasound loops or images during theoretical sessions, could further allow reaching diagnostic accuracy requirements in clinical practice. In the present study, participants will be medical students in their 5th year, naïve to CUS use. Participants will be randomly be distributed between a control group undergoing a standard practical teaching on models presenting uncomplicated gallstones or normal gallbladder (no gallstones), and an intervention group undergoing a practical teaching exclusively on models presenting a normal gallbladder. Participants will be "blinded" to study endpoints as well as to group allocation. After three days of practical teaching on day 0-10-30, students will be evaluated on day 60 by 2 external investigators blinded to students group allocation. Diagnostic accuracy for gallstones will be measured using sensitivity and specificity. Statistical analysis will be performed blinded to students' name using IBM SPSS statistics 26.0 (SPSS Inc., Chicago, IL, USA). As is classical, the statistical tests will be rejected whenever the observed p-value is smaller than 0.05. Corrections for multiple testing will be used. A comparable diagnostic accuracy between groups could further support the use of healthy volunteers during practical teaching and ease clinical ultrasound curricula. Such a finding wouldn't however carry away the need for enhancing competencies during clinical practice or the need for continuing medical education, as for any medical procedure.

NCT ID: NCT04878640 Completed - Clinical trials for Bariatric Surgery Candidate

Sleeve Gastrectomy and Cholecystectomy Are Safe in Obese Patients With Asymptomatic Cholelithiasis

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

Introduction: Obesity is an increasingly serious public health problem on a global level. Gallstones may become symptomatic after sleeve gastrectomy surgery. There is a debate regarding concomitant cholecystectomy during bariatric surgery. Aim of the study: This study analyzed outcomes of laparoscopic sleeve gastrectomy (LSG) with and without concomitant laparoscopic cholecystectomy in morbid obese patients with gall bladder stones. Patients and methods: We conducted randomized clinical study on 222 patients. These patients were categorized into two equal groups (111 in each group) .Group A: underwent SG and concomitant laparoscopic cholecystectomy in morbid obese patient with evidence of gall bladder stone, Group B: SG only without concomitant LC inspite of evidence of gall bladder stone. This study was performed at single institution from January 1, 2016 to January 1, 2019.

NCT ID: NCT04867538 Completed - Clinical trials for Short Bowel Syndrome

The Cholelithiasis in Adults With Short Bowel Syndrome

Start date: January 1, 2010
Phase:
Study type: Observational

Short-term studies have shown that patients with short bowel syndrome (SBS) often develop cholestasis or cholelithiasis. In this retrospective cohort study, we aimed to define the incidence, risk factors, and clinical consequences of cholelithiasis in adults with SBS over an extended time period.

NCT ID: NCT04863482 Recruiting - Clinical trials for Cholecystitis; Gallstone

Safety of Laparoscopic ChOlecystectomy Performed by Trainee Surgeons With Different CHolangiographic Techniques

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

Laparoscopic cholecystectomy (LC) gained popularity among general surgeons in 1990s and rapidly become one of the most commonly performed procedures in digestive surgery, with more than one million cholecystectomies being performed in the United States per year. LC remains also one of the most commonly performed procedure by general surgeons during the training period. Even if previous report LC cases performed by surgical trainees (ST) are not associated with higher operative morbidity, the length of operative time is significantly increased when compared with that of LC cases performed by attending surgeons, due, most of all, to difficulties in identifying the anatomical structure, and this sometimes leads to an attending surgeon taking away the case from the trainee. Furthermore, despite the fact that LC has proven to be a safe procedure, the rate of common bile duct (BDI) injury still remains unacceptably high even in the hands of minimally invasive trained surgeons ranging from 0.2 to 1.5% in individual reports, much higher than initial reports, associated with significant morbidity and mortality, lower quality of life and increased costs, related to additional health care measures, loss of work days, and insurance claims. The aim of this study is to address which of the techniques now available could be addressed as the best option in a training setting to enhance the learning curve, to ideally build a safe cholecystectomy training program and virtually eliminate the risk of BDI due to anatomic misinterpretation during the training period.

NCT ID: NCT04822519 Completed - Gall Stone Clinical Trials

RISK FACTORS OF GALL BLADDER STONE

Start date: April 1, 2021
Phase:
Study type: Observational

Gallbladder disease is a significant health burden in the developed world and its prevalence has risen by more than 20% in the past three decades In the United States, 20-25 million individuals are affected by gallbladder disease, resulting in an average annual treatment cost of $6.2 billion Obesity, diet, rapid weight loss, metabolic syndrome, and conditions such as cirrhosis, Crohn's disease, irritable bowel syndrome, and gallbladder stasis increase the risk of gallstone formation Surgical removal of the gallbladder, cholecystectomy, is the most recommended treatment for gallbladder disease; however, the procedure increases the risk of non-alcoholic fatty liver disease, cirrhosis and metabolic effects

NCT ID: NCT04803487 Completed - Clinical trials for Cholecystitis; Gallstone

Robotic Cholecystectomy Using the Chinese Micro Hand S Robot: A Controlled, Randomized, Prospective Clinical Study

Start date: December 3, 2019
Phase: Early Phase 1
Study type: Interventional

A single-blinded, prospective randomized parallel controlled clinical trial was designed and conducted from December 2019 to November 2020. 82 patients with a gallstone, gallbladder polyp and other benign gallbladder diseases were enrolled in this study. Finally, 82 patients were randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical robot group. Standard robot-assisted transabdominal cholecystectomy was conducted using the Micro Hand S robot or the da Vinci robot. The success rate of operation, assembly time, operation time, intraoperative hemorrhage, time to first flatus, postoperative pain, comprehensive complication index, resident time and patient satisfaciton were recorded. The aim of the study is to determine whether the newly developed Chinese Micro Hand S surgical robot results in non-inferiority outcomes in cholecystectomy compared with the prevalent da Vinci robot.