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Gallstones clinical trials

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NCT ID: NCT06239233 Recruiting - Gallstone Disease Clinical Trials

Gallbladder Infundibulum as a Guide for Ductal Identification.

Start date: December 25, 2023
Phase:
Study type: Observational [Patient Registry]

Introduction: Bile duct injury (BDI) is a catastrophic complication of cholecystectomy, and misidentification of the cystic anatomy is considered to be the main cause. Although several techniques have been developed to prevent BDI, such as the "critical view of safety", the infundibular technique, the rates remain higher during laparoscopic cholecystectomy (LC) than during open surgery. Strategy for ductal identification during laparoscopic cholecystectomy can help to prevent laparoscopic bile duct injury. Methods: A prospective study of 196 patients who will undergo LC during the study period of one year at Nepal Mediciti Hospital will be conducted. The gallbladder infundibulum will be classified by its position located on an imaginary clock with the gallbladder neck as the center point of the dial, 3 o'clock position as cranial, 6 o'clock as dorsal, 9 o'clock as caudal, and 12 o'clock as ventral, as well as the axial position. Patient demographics, pathologic variables and infundibulum classification will be evaluated. Detailed analysis of ductal identification based on gallbladder infundibulum position will be performed in this study. All infundibulum positions will be recorded during intraoperative laparoscopic procedure.

NCT ID: NCT06223061 Active, not recruiting - Gallbladder Cancer Clinical Trials

Global Evaluation of Cholecystectomy Knowledge and Outcomes

GECKO
Start date: July 31, 2023
Phase:
Study type: Observational

Cholecystectomy is amongst the most common surgical operations performed worldwide. Surgical candidates are treated for biliary pathologies, such as biliary colic, cholecystitis and gallstone pancreatitis. In patients who are deemed fit for surgery, cholecystectomy can be performed under three main settings: (1) emergency setting at index admission; (2) elective setting with no previous admissions; or (3) delayed setting with one or more previous gallbladder-related admissions. The advent of laparoscopy fundamentally evolved biliary surgery and quickly became the "gold standard" approach. Recent multicentre collaborative studies have elucidated that the burden imposed on healthcare systems by laparoscopic cholecystectomies is primarily due to patient readmissions and complications arising from the operation, rather than perioperative mortality burden that was more commonly seen in open surgery. As a result, national and international societies have shifted their focus towards creating a culture of safety around this procedure, with the overarching goal of improving patient satisfaction and reducing hospital costs. The universal establishment of safe cholecystectomy is a complex process that relies not only on the operation itself, but also on various other factors such as promoting adequate training, improving hospital infrastructure, and enhancing perioperative patient care. There remains a paucity of evidence around the variations of safe provision of laparoscopic surgery for gallbladder disease internationally, including low- and middle-income countries. To bridge this knowledge gap, the Global Evaluation of Cholecystectomy Knowledge and Outcomes (GECKO) study (GlobalSurg 4) will be an international collaborative effort, delivered by the GlobalSurg network, that will allow contemporaneous data collection on the quality of cholecystectomies using measures covering infrastructure, care processes and outcomes. It will be disseminated via contacts from the National Institute for Health and Care Research (NIHR) Global Surgery unit, leading emergency general surgeons and specialist organisations.

NCT ID: NCT06192719 Recruiting - Gallbladder Cancer Clinical Trials

EULAT Eradicate GBC

EULAT
Start date: December 1, 2019
Phase:
Study type: Observational

Gallstones are relatively frequent in women and constitute one of the main risk factors for gallbladder cancer (GBC). Currently, GBC diagnosis is mainly based on imaging (ultrasound or abdominal CT) associated with invasive examinations (biopsy and surgery), with no marker available to date to accurately predict risk and diagnose the disease early. The only curative treatment for GBC remains surgery with complete resection of tumors in early stages. Given the aggressiveness of GBC and the very limited therapeutic options, as well as the possibility of preventing GBC by cholecystectomy during the 10 to 20 years required for the development of gallbladder tumors, it is imperative to develop effective and efficient prevention strategies based on a prioritization of interventions according to environmental and genetic-molecular risk factors. The investigators aim to identify epidemiological factors linked to the development of GBC, and to identify, validate and functionally characterize genetic-molecular markers in blood, saliva, urine, bile and stool that allow risk prediction, early diagnosis and precision treatment of incidental tumors.

NCT ID: NCT06170632 Not yet recruiting - Bile Duct Diseases Clinical Trials

Flare Type Self-expandable Metal Stents (SEMS) vs Plastic Stent for the Treatment of Difficult Common Bile Duct Stone

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

Migration of stones from the gallbladder to the common bile duct (CBD) facilitated by gallbladder contractions can be listed as a complication of gallstones disease. In the case of common bile duct stone (CBDs) migration, an endoscopic cholangiopancreatography (ERCP) should be offered for both symptomatic and asymptomatic patients fit for the procedure. An ERCP with an adequate endoscopic sphincterotomy obtains a complete biliary clearance in about 80-90% of the patients[5]. Whilst most cases are successfully treated with such first-line approaches, about 10-15% need alternative and/or adjunctive techniques to achieve bile duct clearance. These conditions are generally defined as "difficult" bile duct stones, a broad category of cases that encompasses very different scenarios. In the case of irretrievable CBDs, the European Society of Gastrointestinal Endoscopy (ESGE) recommends the endoscopic placement of a temporary biliary plastic stent to warrant biliary drainage. Since their introduction, fully covered self-expanding metal stents (FCSEMS) have rapidly been adopted for the treatment of benign biliary conditions such as strictures, leaks, or bleeding. In a recent retrospective study it has been shown that FCSEMS are useful in the approach of difficult lithiasis of CBD with no significant adverse events associated. Moreover, a promising FC-SEMS with a particular prosthesis design (flare type - Niti-S "S-Type" Taewoong) could be even more useful since it reduces the frequent complication of fully covered stents which is the migration of the prosthesis. However, prospective data on the effectiveness and on the adverse events rate on the use of SEMS for incomplete stone CBDs clearance are still lacking. Therefore, the investigators aim to estimate the incidence of adverse events, complete biliary clearance, and migration rate after 3-6 month from ERCP index (stent positioning), comparing plastic stents vs FC-SEMS (Niti-S "flare type" - Taewoong).

NCT ID: NCT06130163 Completed - Clinical trials for Cholelithiasis, Common Bile Duct

Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis

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

At our hospital (Kepler University Hospital Linz) we perform all variants of ERCP (preoperative, intraoperative, postoperative ERCP). In cases of simultaneous cholecysto- and choledocholithiasis. Hardly any other hospital in Austria prefers intraoperative ERCP or offers it at all. We have established a standardized procedure with implemented logistics. We want to compare intraoperative and postoperative ERCP.

NCT ID: NCT06124989 Not yet recruiting - Acute Pancreatitis Clinical Trials

Machine learnINg for the rElapse Risk eValuation in Acute Biliary Pancreatitis.

MINERVA
Start date: January 1, 2024
Phase:
Study type: Observational

The MINERVA (Machine learnINg for the rElapse Risk eValuation in Acute biliary pancreatitis) project stems from the need in the clinical practice of taking an operational decision in patients that are admitted to the hospital with a diagnosis of acute biliary pancreatitis. In particular, the MINERVA prospective cohort study aims to develop a predictive score that allows to assess the risk of hospital readmission for patients diagnosed with mild biliary acute pancreatitis using Machine Learning and artificial intelligence. The objectives of the MINERVA study are to: 1. Propose a novel methodology for the assessment of the risk of relapse in patients with mild biliary acute pancreatitis who did not undergo early cholecystectomy (within 3 to 7 days from hospital admission); 2. Propose a Machine Learning predictive model using a Deep Learning architecture applied to easily collectable data; 3. Validate the MINERVA score on an extensive, multicentric, prospective cohort; 4. Allow national and international clinicians, medical staff, researchers and the general audience to freely and easily access the MINERVA score computation and use it in their daily clinical practice. The MINERVA score model will be developed on a retrospective cohort of patients (MANCTRA-1, already registered in ClinicalTrials.gov) and will be validated on a novel prospective multicentric cohort. After validation, the MINERVA score will be free and easy to compute instantly for all medical staff; it will be accessible at any time on the MINERVA website and web app, and will provide an immediate and reliable result that can be a clear indication for the best treatment pathway for the clinician and for the patient.

NCT ID: NCT06123117 Recruiting - Gallbladder Cancer Clinical Trials

STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

STALL
Start date: January 16, 2024
Phase: N/A
Study type: Interventional

This trial is a prospective randomized superiority trial comparing sole ropivacaine based local trocar site infiltration to local infiltration combined with laparoscopic ropivacaine TAP block (STALL) in LCC. There are only a few randomized trials comparing sole local anesthesia to additional laparoscopic TAP block in laparoscopic cholecystectomy and they have yet failed to show evidence in favor of TAP block. We hypothesize STALL (Single Transversus Abdominis Laparoscopy-guided plane block combined with Local trocar site ropivacaine infiltration) is superior to local port site infiltration, provided that the sample size is sufficiently big. The aim of this randomized study is to compare the efficacy of sole local anesthesia of trocar sites to STALL in LCC.

NCT ID: NCT06115941 Completed - Cholelithiasis Clinical Trials

Using Pre-op Incentive Spirometer Reduces Chances of Basal Atelectasis in Patients Undergoing Upper Abdominal Surgeries

Start date: March 29, 2023
Phase: N/A
Study type: Interventional

ABSTRACT Objective: To compare frequency of basal atelectasis in patients undergoing upper abdominal surgery who are provided pre-operative incentive spirometry versus those not provided pre-operative incentive spirometry

NCT ID: NCT06113419 Not yet recruiting - Acute Pancreatitis Clinical Trials

Timing of CHolecystectomy In Severe PAncreatitis

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

The goal of this clinical trial is to compare outcomes for interval or early laparoscopic cholecystectomy in patients with moderately severe and severe pancreatitis. The main question[s] it aims to answer are: - To establish whether there is a difference in surgical outcomes comparing patients diagnosed with severe or moderately severe pancreatitis on which early cholecystectomy was performed versus performing interval cholecystectomy. - The primary endpoint will be to evaluate major complications, defined as a Clavien-Dindo score greater than or equal to III/V. - Secondary endpoints include evaluating minor complications (defined as a Clavien-Dindo score below III/V), biliary disease recurrence, mortality, postoperative hospital stay and postoperative admittance into an intensive care unit. Participants will be randomly assigned to either group: early cholecystectomy during the pancreatitis hospitalization or interval cholecystectomy scheduled 4 weeks after clinical resolution of pancreatitis.

NCT ID: NCT06092905 Recruiting - Clinical trials for Common Bile Duct Calculi

Endoscopic Common Bile Duct Stones Clearance During Pregnancy

Start date: April 1, 2023
Phase:
Study type: Observational

Background: Pregnancy is associated with a higher risk of common bile duct stones. Currently Endoscopic Retrograde Cholangiopancreatography (ERCP) is the treatment of choice for symptomatic choledocholithiasis. However, ERCP during pregnancy is associated with hazards of radiation exposure, as well as challenging patient positioning and anesthesia