Cholelithiasis (Gallstone)

Researchers are evaluating two types of 12-mm self-expandable metallic stents for treating adults with unresectable malignant distal biliary obstruction, a condition caused by cancers such as pancreatic cancer and cholangiocarcinoma. This clinical trial aims to compare the effectiveness and safety of partially covered versus bare metallic stents, as it is unclear which stent type better prevents recurrent biliary blockage and reduces complications. The study is prospective, randomized, and single-center, focusing on patients who have already undergone percutaneous transhepatic biliary drainage PTBD. Participants will be randomly assigned to receive either a 12-mm partially covered or a 12-mm bare metallic stent, both placed through the existing PTBD tract using a percutaneous transhepatic approach. The stent placement will be followed by careful monitoring. The trial includes two groups one receiving the partially covered stent ComVi Biliary Stent and the other the bare stent Niti-S Biliary Uncovered Stent. The study will follow participants for 12 months after stent placement, with assessments at 3, 6, and 12 months. Throughout the study, participants will undergo evaluations to measure the cumulative incidence of recurrent biliary obstruction, stent patency duration, reintervention rates, overall survival, and procedure-related complications such as pancreatitis, cholecystitis, bleeding, perforation, and cholangitis. These assessments involve imaging and clinical follow-up visits. The outcomes will help guide the choice of the most suitable 12-mm metallic stent for patients with this condition, supporting better treatment decisions over a one-year period.

Researchers are evaluating the effectiveness of low volume Transanal Irrigation TAI using the Qufora IrriSedo MiniGo device combined with standard conservative treatments compared to conservative treatment alone for patients with Low Anterior Resection Syndrome LARS. This condition affects individuals who have undergone surgery for rectal cancer. The study aims to assess improvements in clinical symptoms of LARS over a three-month period. Participants are divided into two groups one receiving low volume TAI with the MiniGo device plus standard conservative care, which includes dietary management, counseling, and prescribed medications excluding suppositories and physiotherapy and another group receiving only the standard conservative treatments. The study includes follow-ups at 6 weeks, 3 months, and up to 12 months to monitor various outcomes. During the study, participants will be regularly assessed using the LARS score to measure symptom changes, quality of life questionnaires EORTC QLQ-C30 and QLQ-CR29, incontinence scores, patient satisfaction, treatment compliance, bowel management time, and healthcare resource usage. Data will be collected at multiple intervals including 6 weeks, 3 months, 6 months, 9 months, and 12 months to thoroughly evaluate the treatment impact and patient preferences.

Gallstones are a common health issue, and their occurrence has been increasing worldwide. This research aims to evaluate whether dietary therapy can help in expelling early-stage gallstones, specifically those present in a sludge-like form, which currently lack effective treatment options. The trial is a double-blind, prospective study conducted at a single medical center to investigate this question. Participants are randomly assigned to receive either functional fatty acids or a placebo orally. The treatment period lasts six days, with the experimental group taking functional fatty acids throughout. The placebo group receives placebo for the first three days, followed by functional fatty acids for the next three days. This design allows comparison of gallstone expulsion effectiveness between the groups. During the study, participants will undergo assessments including sonographic evaluation of gallbladder sludge expulsion after three and six days, as well as measurements of gallbladder volume and wall thickness. Researchers will also monitor blood bilirubin levels and observe any post-intervention symptoms such as abdominal pain, acute pancreatitis, gastrointestinal bleeding, nausea, vomiting, and diarrhea. The study period and follow-up span up to two weeks, ensuring thorough safety and outcome monitoring.

Researchers are evaluating how artificial intelligence AI can improve safety during laparoscopic cholecystectomy, a minimally invasive gallbladder removal surgery. This study compares surgeries guided by AI tools to standard procedures without AI, focusing on whether AI helps surgeons achieve the Critical View of Safety, a key step to reduce the risk of serious complications. This randomized controlled trial includes surgeons or fellows performing the procedures and aims to collect feedback on AI use and surgical safety outcomes. The study involves 10 surgeons or fellows and 50 adult patients undergoing laparoscopic cholecystectomy at two hospital sites. Participants are randomly assigned to either the control group using standard surgical care or the intervention group where surgeons receive real-time guidance from two AI models displayed on a monitor during surgery. The AI models highlight safe and unsafe dissection zones and provide text feedback on achieving surgical safety milestones. Surgeons can toggle or turn off AI guidance as needed. Procedures are recorded for post-operative review by expert surgeons. During the study, researchers will collect internal laparoscopic recordings, surgeon feedback immediately after surgery, observational notes during procedures, and review patient charts up to 30 days post-operation. The primary outcome is the rate at which surgeons achieve the Critical View of Safety, monitored for up to one year after surgery. Secondary outcomes include the safety of dissections, surgeon experience with AI, and short-term patient outcomes. The study lasts from surgery through one year of follow-up for outcome analysis.

This research evaluates the use of the AnalgesiaNociception Index ANI to guide desflurane anesthesia during laparoscopic cholecystectomy in adults aged 19 to 65 years with good physical health ASA I-II. ANI measures parasympathetic tone to assess pain and analgesia balance, aiming to improve opioid titration, reduce anesthetic consumption, and stabilize hemodynamics during surgery. Participants are randomly assigned to either an ANI-guided group or a standard care group. Both groups receive general anesthesia with propofol induction followed by maintenance with desflurane and remifentanil. The ANI-guided group adjusts desflurane doses based on ANI values and BIS monitoring, while the control group follows standard vital sign and BIS-based titration. ANI is monitored in both groups but only guides dosing in the ANI group. Recovery includes neuromuscular monitoring and use of sugammadex for muscle relaxation reversal. During the study, participants undergo continuous monitoring of heart rate variability, blood pressure, and baroreflex sensitivity to assess autonomic function. Outcomes measured include desflurane concentration, emergence time, postoperative pain, hemodynamic stability, length of stay in recovery, need for additional pain medications, nausea and vomiting incidence, and patient satisfaction. Data collection spans from anesthesia induction through surgery and up to 24 hours postoperatively, with safety and recovery closely tracked.

Researchers are studying patients with suspected choledocholithiasis, a condition involving gallstones in the bile duct, who fall into an intermediate likelihood group based on current risk criteria. The study aims to evaluate how a machine learning model can help predict choledocholithiasis and potentially reduce the need for additional diagnostic procedures like Endoscopic Ultrasound EUS or Magnetic Resonance Cholangiopancreatography MRCP. This approach may lower healthcare use and costs for these patients. This observational study uses a machine learning-based predictive model to stratify patients who otherwise might undergo EUS or MRCP. Participants are those aged 18 to 80 years with intermediate risk of choledocholithiasis. The models performance in predicting the condition will be assessed, focusing on accuracy and receiver operating characteristic curve analysis within one month. Participants will be monitored through diagnostic evaluations including EUS or MRCP as needed, with data collected to validate the machine learning model. Researchers will measure the models accuracy and compare it to the diagnostic tests. The study will track outcomes over one month, assessing how well the model predicts the presence of choledocholithiasis and its potential to reduce unnecessary diagnostic procedures.

Researchers are studying how fluctuations in anesthesia depth during surgery, measured by bispectral index BIS monitoring, affect patients recovery quality after surgery. This observational study focuses on adults undergoing elective laparoscopic gallbladder removal under general anesthesia. The goal is to understand the relationship between BIS variability during anesthesia and changes in recovery quality as measured by a specific questionnaire. All participants will receive standard general anesthesia care with BIS monitoring as part of routine practice. BIS values will be recorded throughout the surgery without altering usual anesthesia management. Recovery quality will be assessed before surgery and again on the first day after surgery using the Quality of Recovery-15 QoR-15 questionnaire. Additional data like delirium screening and perioperative clinical information will also be collected. Participants will complete the QoR-15 questionnaire before surgery and on postoperative day one. Researchers will collect BIS data continuously during the procedure and record other clinical information. The main measure is the change in QoR-15 score from before surgery to the first postoperative day. Additional outcomes include postoperative delirium and pain intensity. The study does not involve interventions beyond routine care and aims to improve understanding of how anesthesia stability impacts recovery.

The Calgary Registry for Advanced and Therapeutic Endoscopy CReATE is a high-quality, prospective study collecting data on adult patients undergoing Endoscopic Retrograde Cholangiopancreatography ERCP for biliary and pancreatic diseases. The registry aims to gather detailed information from multiple centers to better understand outcomes and complications related to this advanced endoscopic procedure. Participants undergo ERCP, an endoscopic procedure used to access biliary and pancreatic structures. The study observes patients consecutively from September 2018 to August 2022, capturing all relevant data before, during, and after the procedure. This includes procedural details and patient outcomes, serving also as a platform for additional prospective studies and randomized trials. During the study, a full-time research assistant collects real-time data by observing procedures directly. Participants are followed up with medical record reviews and phone interviews 30 days after the procedure to assess outcomes such as unplanned healthcare visits and procedure-related complications including pancreatitis, bleeding, and infections. The registry monitors technical success immediately and tracks patients health for up to 30 days post-procedure, contributing to ongoing research until the study ends in 2030.

This research aims to compare two approaches to intraoperative cholangiography IOC during gallstone surgery for patients without suspicion of common bile duct stones CBDS. Gallstone disease can lead to complications if stones migrate into the bile duct. The study evaluates whether performing IOC routinely or only selectively when there is uncertainty about bile duct anatomy affects the risk of complications like pancreatitis, bleeding, or bile duct injury. It is a national multicenter randomized controlled trial embedded in the Swedish Registry for Gallstone Surgery GallRiks. Participants will be randomly assigned to either routine IOC, where the procedure is attempted in all cases regardless of indication, or selective IOC, where it is only attempted if the anatomy is unclear. Both groups undergo laparoscopic cholecystectomy for gallstone-related disease. The study plans to recruit 6,000 patients and will follow them for one year after surgery to compare outcomes. Secondary measures include procedure time, mortality, hospital stay, quality of life, and healthcare costs. During the study, participants will have data collected through the GallRiks registry, including surgical details and follow-up evaluations at 30 days and one year. Quality of life questionnaires SF-36 and EQ5D will be completed at baseline, 30 days, and one year post-surgery. Researchers will monitor for readmission or reintervention related to the cholecystectomy within 12 months as the primary outcome. Safety and complications will also be tracked through routine patient record review and surgeon consultation when needed.

This research aims to compare the safety and effectiveness of laparoscopic cholecystectomy versus a wait-and-see approach in elderly patients who have had common bile duct stones successfully removed using endoscopy. The study focuses on patients 75 years and older, including those with additional health issues, to determine if avoiding surgery is as safe as performing cholecystectomy. The main measurement is a combined outcome of death, serious complications, or recurring biliary problems within one year after randomization. Participants are randomly assigned to one of two groups one will have laparoscopic cholecystectomy within two weeks following stone removal, and the other will be managed without surgery but can have cholecystectomy later if needed. The study includes an interim safety check after the first 100 participants, with a plan to stop early if significant differences arise. Both groups are monitored over time to assess health outcomes and complications. During the study, participants will be followed for at least one year to track outcomes such as survival, complications, biliary events, quality of life, pain, and healthcare costs. Assessments occur at various intervals, including 30, 180, and 365 days after randomization. Researchers will evaluate these factors carefully to understand the benefits and risks of each approach, ensuring participant safety throughout the trial.