Clinical Research Directory

SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis

This study aims to understand how different treatment approaches for acute gallbladder inflammation (acute calculous cholecystitis) affect patient outcomes in real-world hospital settings. Acute calculous cholecystitis is a common condition that occurs when gallstones block the gallbladder and cause infection or inflammation. In more severe cases, patients may develop organ dysfunction, and doctors must decide quickly how best to treat the condition. Treatment options include early surgery to remove the gallbladder, placement of a drainage tube, or treatment with antibiotics alone. The best approach is not always clear, especially for patients who are older, have other medical conditions, or are very unwell. This study will collect information from hospitals around the world about how patients with severe gallbladder inflammation are treated as part of their usual care. No treatments are assigned by the study. All decisions are made by the patient's clinical team. The goal is to compare outcomes between different treatment approaches in patients who could reasonably receive more than one option. The study will examine recovery, survival, need for additional procedures, and time spent in the hospital over 90 days. The findings are intended to help doctors and patients better understand which treatment strategies may lead to better outcomes in different clinical situations, and to improve decision-making in emergency surgical care.

Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis

The goal of this clinical trial is to learn if endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) works better than percutaneous gallbladder drainage (PT-GBD) for people with acute cholecystitis (inflammation of the gallbladder) who cannot undergo immediate surgery. The main questions this study aims to answer are: * Does EUS-GBD lead to fewer serious medical problems and fewer additional procedures within 30 days after treatment? * Does EUS-GBD improve quality of life compared with PT-GBD? Researchers will compare two methods of draining the gallbladder to see which treatment leads to better outcomes. Participants will: * Be randomly assigned to receive either EUS-GBD or PT-GBD. * Receive gallbladder drainage performed by experienced specialists. * Complete questionnaires about their health and quality of life before treatment and during follow-up. * Have follow-up visits or telephone consultations at 7, 30, 182, and 365 days after the drainage procedure. The study will include participants from hospitals in several (European) countries.

Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis

The goal of this interventional, prospective study is to determine the clinical utility of a repeat point-of-care ultrasound of the gallbladder in adult emergency department patients with abdominal pain for which initial imaging is not diagnostic. The main question it aims to answer is: Does a repeat ultrasound improve early identification of gallbladder inflammation? Participants will undergo a repeat ultrasound of the gallbladder while still in the emergency department and will be followed up to determine subsequent diagnoses, disposition, consultations and other clinical information.

Safety and Efficacy of EUS-guided Gallbladder Drainage Under Endoscopist-directed Conscious Sedation

This prospective single-center study was designed by the investigators to evaluate the feasibility, safety, and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) performed under endoscopist-directed conscious sedation in elderly, high-risk patients with acute cholecystitis. The study aims to assess whether conscious sedation represents a viable alternative to deep sedation or general anesthesia in this fragile patient population.

Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy

Background Acute cholecystitis (sudden gallbladder inflammation, usually due to gallstones) is a highly frequent surgical emergency. For patients with moderate disease (Grade II, according to the international Tokyo Guidelines 2018), current standards recommend performing keyhole surgery (early laparoscopic cholecystectomy) within 72 hours of admission or up to 10 days from symptom onset. While the surgical timing is well-defined, care management before, during, and after surgery varies greatly. Standardised care pathways called RICA (Rehabilitación Multimodal en Cirugía del Adulto), which align with global Enhanced Recovery After Surgery (ERAS) protocols, use evidence-based steps to protect body function, reduce pain without heavy opioid use, and help patients walk and eat sooner. Although highly successful in planned surgeries, there is very little specific data or standard pathways regarding the application of these recovery protocols in urgent, complex cases like Grade II acute cholecystitis. Purpose The main objective of this study is to evaluate the clinical efficiency and safety of implementing a standardized RICA perioperative care pathway in patients with Grade II acute cholecystitis undergoing early laparoscopic cholecystectomy, comparing them against a historical control group treated under conventional care. Description This single-centre, non-randomised interventional study uses a quasi-experimental, before-after design at the University Hospital of Igualada. The study will contrast two separate groups of adult patients aged between 18 and 85 years: * A historical control cohort (retrospective phase, 2023-2025) consisting of patients who received conventional, non-standardised care. * An intervention cohort (prospective phase, 2026-2029) consisting of patients treated strictly according to the new multidisciplinary RICA protocol. The study aims to demonstrate that standardising care reduces the total postoperative length of hospital stay (measured in hours) without increasing surgical complications or unplanned readmissions. All clinical variables, including patient risks, surgical difficulty scales, complications up to 90 days, and protocol compliance rates, will be securely managed using an institutional REDCap database.

Comparison of Gallbladder Extraction Via Subxiphoid vs Infraumbilical Port in Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is the standard surgical treatment for symptomatic gallstone disease due to its advantages in reducing postoperative pain and recovery times. However, surgeons continue to debate the optimal port site for retrieving the gallbladder specimen from the abdominal cavity, as this choice can influence wound-related morbidity. Traditionally, the gallbladder is extracted through the infraumbilical port site. While effective, this route is associated with a potential risk of port-site infections due to bacterial colonization within the umbilicus and risk of contamination during specimen extraction. Retrieving the gallbladder through the subxiphoid port has been proposed as an alternative technique that may utilize a cleaner surgical site, potentially reducing patient pain scores and regional wound complications. This prospective randomized clinical trial aims to directly compare the clinical outcomes of extracting the gallbladder through the subxiphoid port versus the traditional infraumbilical port. The study will evaluate and compare mean postoperative pain intensity within the first 24 hours, as well as the regional development of port-site infections, seromas, or hematomas within 7 days following elective laparoscopic surgery.

Endoscopic vs Non-endoscopic Drainage for Benign Gallbladder Diseases in High-risk Patients or Patients Desiring Gallbladder Preservation

Common gallbladder conditions like gallstones, polyps, and gallbladder inflammation are typically treated by surgically removing the gallbladder. However, surgery may be too risky for elderly patients or those with severe medical conditions, and some patients strongly prefer to keep their gallbladder. Newer, less-invasive endoscopic treatments can drain the gallbladder to treat inflammation without surgery. However, after successful drainage, doctors currently do not know whether it is better to leave a stent inside for long-term drainage or to actively remove the gallbladder stones using an endoscope. This multicenter study will follow patients in a real-world setting to compare these two approaches: the endoscopic treatment group (stone removal after drainage) and the non-endoscopic treatment group (long-term drainage alone). The goal is to evaluate which method is safer and more effective over the long term, helping doctors make better clinical decisions and improve patients' quality of life.

PT-GBD to EUS-GBD Conversion Versus Standard Management in High-Risk Acute Cholecystitis Patients

Acute cholecystitis in high-risk surgical patients is commonly managed with percutaneous trans-hepatic gallbladder drainage (PT-GBD). However, long-term adverse events, tube dysfunction, and recurrent cholecystitis remain significant concerns. This retrospective multicenter observational study compares long-term outcomes of conversion from PT-GBD to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stents (LAMS) versus standard management in high-risk surgical patients with acute cholecystitis.

Bile Aspiration vs Drain in Acute Cholecystitis

In order to compare percutaneous cholecystostomy and leaving a drain in situ with percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled trial.

Prevention of Postoperative Hernias in Emergency Surgery

The aim of this observational study is to understand the risk factors and incidence of postoperative hernias among patients undergoing emergency surgery. The main question it aims to answer is: What is the incidence of postoperative hernias in this group of patients? A brief telephone interview will be conducted with participants who will be included in this study one year after the surgery. If the presence of a postoperative hernia is suspected, the patient will be invited to a follow-up visit to the surgical clinic, where the diagnosis will be confirmed by imaging tests.

EOIB for Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy, while less painful compared to conventional methods, is still a surgery that can cause significant pain for patients. Preventing postoperative pain is crucial for reducing respiratory complications, shortening hospital stays, and increasing patient satisfaction. Interfascial plane blocks have been widely used for postoperative analgesia in recent years worldwide. The External Oblique Intercostal Plane Block is one of the interfascial plane blocks used in abdominal surgeries. In our study, we aimed to compare the postoperative pain scores of patients who underwent laparoscopic cholecystectomy under general anesthesia, specifically between those who received the external oblique intercostal plane block and those who had trocar entry site infiltration.

Optimal Timing for Laparoscopic Cholecystectomy After Cholecystostomy in Acute Cholecystitis Tokyo II/III Setting

Percutaneous drainage in acute cholecystitis has been recommended by the recent update of the Tokyo Guidelines for patients with grade II and III disease who are unable to undergo surgical treatment due to their condition or associated comorbidities. There are no reports providing high-quality scientific evidence on the optimal timing for surgery after percutaneous transhepatic gallbladder drainage, so a consensus has not been reached. The grade III stage generates the most controversy; after percutaneous drainage, delaying the cholecystectomy can lead to new episodes of exacerbation during the waiting period or may limit the procedure to a specific group of patients with this pathology. The economic impact, including the number of readmissions, increased length of stay, and associated morbidity and mortality, generates controversy regarding the subsequent therapeutic decisions after the medical management of cholecystitis in this special group of patients.

Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique

The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside.

Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis

In this project the investigators propose to carry out a clinical trial that compares non-endoscopic treatment of cholecystitis with antibiotics versus endoscopic drainage in non-operable acute cholecystitism (AC), especially focused on the rate of subsequent EBP and recurrence of AC, as well as the impact on the quality of life, also exploring the costs. The ultimate goal of this project is to generate knowledge and scientific evidence that makes it easier for health professionals to choose the most appropriate strategy for non-operable patients with lithiasic AC. Ourworking hypothesis is that endoscopic treatment (EUS-GBD) will significantly reduce the number of EBP compared to non-endoscopic treatment in patients with non-operable lithiasic AC.