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Bile Duct Injury clinical trials

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NCT ID: NCT06223061 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: NCT05709548 Recruiting - Acute Cholecystitis Clinical Trials

Use of Indocyanine Green in Acute Cholecystitis

INDURG
Start date: March 15, 2023
Phase: Phase 4
Study type: Interventional

Laparoscopic cholecystectomy is one of the most common gastrointestinal surgeries. However, it can be technically complex in those patients diagnosed with acute cholecystitis who present severe inflammation or fibrosis, with bile duct injury being one of its main complications. The use of fluorescence cholangiography through the use of indocyanine green allows the identification of extrahepatic biliary structures, facilitating dissection and reducing the risk of bile duct lesions. Better visualization of the bile duct allows reducing the conversion rate to open surgery, as well as operating time. The main objective is to assess a decrease in operating time in acute cholecystitis undergoing emergency surgery, to which indocyanine green is administered preoperatively. Randomized, prospective, controlled, multicenter clinical trial of two groups of patients diagnosed with acute cholecystitis and requiring urgent cholecystectomy. The control group includes 220 patients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green, and the intervention group includes 220 patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively. Study led by the Parc Taulí University Hospital in Sabadell.

NCT ID: NCT05169073 Recruiting - Virtual Reality Clinical Trials

Virtual Reality Training for Laparoscopic Cholecystectomy

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

Cholecystectomy is one the most frequent laparoscopic procedures worldwide. It is a safe and effective operation but intraoperative bile duct injury remains a relevant complication with serious consequences for the patient. Most of the complications occur due to a lack of knowledge of the anatomy or misidentification of the cystic duct. Thus, the study of the anatomy is a cornerstone of a successful procedure and the preoperative magnetic resonance cholangiopancreatography (MRCP) is a way to preoperatively determine relevant structures to avoid intraoperative incidents. This trial has been designed to assess the effect of preoperative virtual reality training based on MRCP on intraoperative performance and outcome.

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: NCT03774589 Recruiting - Pancreatic Cancer Clinical Trials

Bilioenteric Anastomosis by Magnetic Compressive Technique

BAMCT
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on bilioenteric anastomosis.

NCT ID: NCT03716232 Recruiting - Biliary Stricture Clinical Trials

Kaffes Stent in the Management of Post-surgical Biliary Strictures

Start date: July 1, 2018
Phase: Phase 3
Study type: Interventional

Post-surgical biliary strictures are common especially after cholecystectomy. Standard treatment involves the performance of multiple procedures over a 1 year period at least using several plastic stents to achieve permanent dilatation of these strictures. Metallic stents have the theoretical benefit of absence of need of multiple sessions. These strictures however are frequently very close to the hilum and thus previously considered a contraindication for insertion of metallic stents for the fear of occlusion of the contralateral ducts. Metallic stent migration is also a frequent problem. The use of a metallic stent that is short and completely intraductal, in theory, should reduce the risk of stent migration. This is a randomized controlled trial comparing the efficacy and safety of a short metallic intraductal stent to the conventional treatment which is multiple plastic stents. In cases with a stricture reaching or close to the hilum a technique is used to avoid obstruction of the contralateral ducts which is insertion of a 7 French plastic stent alongside the metallic stent.

NCT ID: NCT03386201 Recruiting - Bile Duct Injury Clinical Trials

FLuorescence Cholangiography Using Methylene Blue

FLoCaMB
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.

NCT ID: NCT02801500 Recruiting - Clinical trials for Hilar Cholangiocarcinoma

Superior Bilioenteric Anastomosis by Magnetic Compressive Technique

CTREG
Start date: July 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on superior bilioenteric anastomosis.