View clinical trials related to Gallstones.
Filter by: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.
The aim of the trial is to compare the routes of administration of indocyanine green (ICG) during laparoscopic cholocystectomy.
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.
In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including endoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy has become gold standard for treatment of CBDS in Denmark. However, ERC is associated with a high risk of complications and more than 50% of patients require multiple ERCs. Recent meta analyses find that a one-step approach might be superior in terms of safety, CBDS clearance rate, hospital stay, operative time, hospital cost and stone recurrence, but much more data is needed. The preGallstep trial is an investigator-initiated multicentre randomised clinical pilot trial with blinded outcome assessment investigating a novel one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus conventional two-step endoscopic retrograde cholangiography with stone extraction plus a subsequent laparoscopic cholecystectomy for patients with CBDS. After enrolment, the participant will be randomised to one of the two treatment approaches. Adult patients with imaging confirmed CBDS are eligible for inclusion. Potential postoperative complications will be assessed within 90 days following the procedure. The primary outcome is the proportion of serious adverse events (corresponding to a Clavien-Dindo score II or above) requiring re-intervention within 90 days of the initial procedure. This outcome will be used for a future sample size calculation. The sample size estimate, the inclusion rate and the estimated length of subsequent trial will be used to determine the feasibility of a large pragmatic and confirmatory trial. We hypothesize that the one-step approach will significantly reduce the risk of complications and number of treatments needed thereby making a difference to hundreds of people in Denmark each year.
Acute pancreatitis (AP) is an inflammatory disease of the pancreas, most commonly caused by gallstones, or excessive use of alcohol. It represents a management challenge and a significant healthcare burden. The incidence of AP ranges globally from 5 to 30 cases per 100.000 inhabitants/year, and there is evidence that the incidence has been rising in recent years. The overall case-fatality rate for AP is roughly 5%, and it is expectedly higher for more severe stages of the disease. In most cases (80%), the outcome of AP is rapidly favorable. However, acute necrotizing pancreatitis (ANP) may develop in up to 20% of cases, and is associated with significant rates of early organ failure (38%), needing some type of surgical/endoscopic intervention (38%) and death (15%). In the United States, AP is a leading cause of inpatient care among gastrointestinal conditions: more than 270.000 patients are hospitalized for AP annually, at an aggregate cost of over 2.5 billion dollars per year. In Europe, the UK incidence of AP is estimated as 15-42 cases per 100.000/year and is rising by 2.7% each year. Despite existing evidence-based practice guidelines for the management of biliary AP, clinical compliance with recommendations is poor, with studies on this field identifying major discrepancies between evidence-based recommendations and daily clinical practice. Audits about biliary AP have been performed in Italy, Germany, France, and England, with quite disappointing results. Indeed, in these audits, the treatment of biliary AP differed substantially from the recommendations. For example, less than 15% of the responders stated that they strictly followed all recommendations included in the guidelines in Germany and 25.8% of patients did not receive definitive treatment for biliary AP within 1 year in the UK. These findings support the view that publication alone of nationally or internationally developed and approved guidelines is insufficient to modify the practice of non-specialists and raises the question of how best to spread guideline recommendations. In 2020, the spread of the virus Covid-19 has represented a pandemic that also had a profound impact on the surgical community. There are many ways through which the outbreak of the Covid-19 pandemic could have influenced daily clinical practice for patients with biliary AP also leading to a failure to adhere to the recommendations coming from the guidelines, especially those regarding the early and definitive treatment with cholecystectomy or ERCP and sphincterotomy. First of all, the recommendation to postpone all non-urgent endoscopic procedures during the peak of the pandemic. Second, the recommendation to conservatively treat inflammatory conditions such as acute cholecystitis and acute appendicitis wherever possible. Since the clinical compliance with recommendations about AP is poor and the impact of implementing guideline recommendations in biliary AP has not been well studied on a global basis, we launched the MANCTRA-1 study with the aim to demonstrate areas where there is currently a sub-optimal implementation of contemporary guidelines on biliary AP. Moreover, we argue that during the Covid-19 pandemic the tendency to disregard the guidelines recommendations has been more marked than usual and we will try to find out if AP patients' care during the Covid-19 pandemic resulted in a higher rate of adverse outcomes compared to non-pandemic times due to the lack in the compliance of the guidelines. The MANCTRA-1 can identify a number of areas for quality improvement that will require new implementation strategies. Our aim is to summarize the main areas of sub-optimal care to provide the basis for introducing a number of bundles in the management of AP patients to be implemented during the next years. The primary objective of the study is to evaluate which items of the current AP guidelines if disregarded, correlate with negative clinical outcomes according to the different clinical presentations of the disease. Secondary objectives are to assess the compliance of surgeons worldwide to the most up-to-date international guidelines on biliary AP, to evaluate the medical and surgical practice in the management of biliary AP during the non-pandemic (2019) and pandemic Covid-19 periods (2020), and to investigate outcomes of patients with biliary AP treatment during the two study periods.
The investigators want to study the effectiveness of prophylactic cholecystectomy in patients with midgut neuroendocrine tumor (jejunum, ileum or proximal colon) who require primary tumor surgery. When patients are diagnosed and are tributary to surgical treatment, the tumor might compromise vascularization, and patients need an extensive bowel resection. The patients might also receive medical treatment with somatostatin analogs. The combination of extensive bowel resection and medical treatment might increase gallbladder stones, but patients might not develop biliary stone disease, as in the general population, where 20% of the population have gallbladder stones but only a 10 to 15 % of the population will develop symptoms. The idea comes from the lack of literature about the incidence of biliary Stone disease in patients with midgut NET tumors. It's a multicentric, open-label and randomized clinical trial to evaluate the incidence of biliary stone disease in patients with midgut NET who require primary tumor surgery combined or not to cholecystectomy. Our hypothesis suggests that patients with midgut neuroendocrine tumor who require primary tumor resection without the combination of prophylactic cholecystectomy do not have an increased incidence of biliary stone disease two years after the surgery, regardless of treatment with SSA.
Standard Pressure Laparoscopic Cholecystectomy，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis. According to literature, low pressure laparoscopic cholecystectomy is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, the previous studies have presented controversial results. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.
Choledocholithiasis refers to the presence of gallstones within the common bile duct. It is proposed to look for markers that help in the diagnosis and in differentiating between retained and migrated gallstones. The selection of patients is a very important aspect, due to the economic aspects and possible complications. Taking advantage of the development of technology, the improvement in computer systems, the use of artificial intelligence and a symbolic regression model that works to predict the presence of choledocholithiasis and provide evidence that clarifies the treatment of patients with this pathology, especially in this group where there is a bigger controversy.
- (Cause of cholelithiasis) Recently, the average age has increased, and the occurrence of gallstones has increased as the dietary life has been westernized due to the improvement of socio-economic level. When cholesterol increases, the occurrence of gallstones increases. Factors include high-calorie high-fat diet, increasing age, women, pregnant women, obesity, and oral contraceptives. There are cases. As another cause, gallstones occur well even when bile stasis occurs due to a decrease in motility of the gallbladder. These are conditions that lower mobility. And cholelithiasis has a genetic tendency in about 30%. In addition, since the eating habits of the family are similar, the genetic factors and the eating habits overlap, which often leads to the occurrence of cholelithiasis in the family. - (symptoms of cholelithiasis) In most cases, complaints of non-specific digestive system symptoms, such as abdominal bloating, nausea, and especially indigestion after fatty diet, are often observed. According to domestic reports, the nonspecific symptoms complained by patients with cholelithiasis were indigestion, flatulence, frequent belching, nausea, loss of appetite, diarrhea, and vomiting. In general, many healthy people without gallstones complain of non-specific digestive system symptoms in 50% of cases, and there is a possibility that functional gastrointestinal diseases such as dyspepsia, peptic ulcer, and gastritis may be accompanied by these digestive system symptoms. It is difficult to know whether it is unrelated to gallstones. Symptoms caused by typical cholelithiasis usually have a characteristic that they often improve on their own after a few hours, and the start and end of the symptoms are relatively clear and repeatedly occur. In addition, various symptoms are displayed depending on the presence or absence of inflammation and progression. - (Principle of treatment of cholelithiasis) 1. Medical treatment: Medical treatment of gallstones is a method of dissolving using drugs to treat cholesterol gallstones in gallbladder stones. In 1973, Nakano et al. [1] published the first example of dissolving cholesterol gallstones using ursodeoxycholic acid (UDCA). Currently, UDCA is the only drug administered to patients with asymptomatic or mild symptoms of cholelithiasis in actual clinical practice, and there is no specific prescription drug. 2. Surgical treatment: In the case of indications of cholecystectomy, acute cholecystitis, severe symptoms, chronic cholecystitis with severe thickening of the gallbladder wall, repeated and severe symptoms, porcelain gallbladder, Patients with gallstones of 3 cm or more in size, patients with anomalous pancreato-biliary duct unions, or gallbladder polyps. - (Study on increasing gallbladder contractility) So far, there have been studies that some drugs increase or decrease gallbladder contractility. Catnach SM et al. [2] reported that erythromycin increased gallbladder contractility in patients with autonomic neuropathy due to diabetes. Sengupta S et al. [3] reported that indoramin (α-adrenergic antagonist), a prokinetic agent, increased gallbladder contractility in patients with cholelithiasis, resulting in a significant decrease in gallbladder volume. Motilitone® developed in Korea is a gastrointestinal motility stimulator that stimulates 5-HT4 receptors to increase acetylcholine secretion and has a mechanism of contracting smooth muscles, improving symptoms in patients with functional dyspepsia in cholelithiasis It is expected to be able to give, and it is thought to have the effect of preventing the crystallization of bile acids due to an increase in the gallbladder contractility, thereby preventing the formation of gallstones and preventing newly generated gallstones. To date, there are no special drugs for dyspepsia or pain improvement in patients with cholelithiasis. It is hypothesized that administration of motilitone® will increase the contractile capacity of the gallbladder, thereby improving digestion and preventing further formation of gallstones. As a control group, Gasmotin® was administered to improve functional dyspepsia, and the degree of symptom improvement was measured and compared by completing the Symptom Score Questionnaire for Indigestion between the two groups.
The main objective of this pilot study is to show feasibility to collect peri-operative and postoperative clinical data of the study group of gastric bypass without cholecystectomy compared with the control group of gastric bypass with cholecystectomy. Our hypothesis is that the approach without cholecystectomy would be superior in terms of a decrease of perioperative adverse events and postoperative complications, as well as lenght of operation, lenght of hospital stay, overall costs with a very low risk of biliary complication in the follow up. These findings could be helpful to build a baseline for a future randomized controlled multicenter study allowing significance of these results and help orientate surgeons towards best surgical care of the gallbladder with confirmed absence of stones in the obese patient undergoing gastric bypass.