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Cholelithiasis clinical trials

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NCT ID: NCT04822519 Completed - Gall Stone Clinical Trials

RISK FACTORS OF GALL BLADDER STONE

Start date: April 1, 2021
Phase:
Study type: Observational

Gallbladder disease is a significant health burden in the developed world and its prevalence has risen by more than 20% in the past three decades In the United States, 20-25 million individuals are affected by gallbladder disease, resulting in an average annual treatment cost of $6.2 billion Obesity, diet, rapid weight loss, metabolic syndrome, and conditions such as cirrhosis, Crohn's disease, irritable bowel syndrome, and gallbladder stasis increase the risk of gallstone formation Surgical removal of the gallbladder, cholecystectomy, is the most recommended treatment for gallbladder disease; however, the procedure increases the risk of non-alcoholic fatty liver disease, cirrhosis and metabolic effects

NCT ID: NCT04765618 Completed - Clinical trials for The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss

The Incidence of Gall Stones After Bariatric Surgery and Its Association With Weight Loss

Start date: December 26, 2018
Phase:
Study type: Observational

The incidence of Gall Stones after Bariatric surgery and its association with weight loss

NCT ID: NCT04747990 Recruiting - Covid19 Clinical Trials

coMpliAnce With evideNce-based cliniCal Guidelines in the managemenT of Acute biliaRy pancreAtitis

MANCTRA-1
Start date: April 1, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT04737642 Completed - Surgery Clinical Trials

Feasibility and Safety of Bile Duct Clearance by Transcystic Sphincter of Oddi Balloon Dilatation

TCPBD
Start date: January 4, 2021
Phase: N/A
Study type: Interventional

To investigate feasibility and safety of intraoperative bile duct clearance by sphincter of Oddi balloon dilatation via cystic duct at cholecystectomy. Primary endpoint: rate of successful bile duct stone clearance (feasibility). Secondary endpoints (safety): rate of peri-interventional complications (injury to the common bile duct, bleeding, injury to surrounding organs: stomach, duodenum, liver) and short-term postoperative complications (bile leak, cholangitis, lipasaemia, pancreatitis, pneumonia). Duration of procedure. Length of hospital stay.

NCT ID: NCT04735198 Recruiting - Biliary Stones Clinical Trials

Prophylactic Cholecystectomy in Midgut NETs Patients Who Require Primary Tumor Surgery.

TNE-IDC-COLE
Start date: January 20, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04693156 Completed - Clinical trials for Laparoscopic Cholecystectomy

Comparison of Oblique Subcostal, Posterior or Dual Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy

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

The aim of the study is to evaluate the difference of postoperative analgesic effects and opioid consumption between ultrasound-guided unilateral oblique subcostal, posterior, or dual TAP blocks in patients undergoing laparoscopic cholecystectomy for cholelithiasis.

NCT ID: NCT04675190 Completed - Surgery Clinical Trials

Major Surgery as a Risk of Gall Stone Disease?

Start date: October 22, 2020
Phase:
Study type: Observational

Gall stone disease is one of the most common diseases occurring in the world as well as in our country, Nepal. This disease is problematic to a lot of patients and poses a huge economic burden to the country. Gall stone disease is usually diagnosed by abdominal ultrasonography as echogenic foci that cast an acoustic shadow. The risk factors for the development of gall stones are multiple; age, sex, genetic susceptibility, pregnancy, dyslipidemia, obesity, rapid weight loss, prolonged fasting and parenteral nutrition, spinal cord injury, cirrhosis, hyperbilirubinemia, and Crohn's disease. In cases of prolonged fasting, total parenteral nutrition, and spinal cord injury; biliary stasis due to lack of enteral stimulation is thought to contribute for the development of gall stones.8 Biliary stasis leads to the formation of sludge which consists of mucus, calcium bilirubinate, and cholesterol crystals. It has been established that several drugs viz.fibrates, ceftriaxone, somatostatin analogues and oral contraceptive pill can promote gall stone formation. The elective surgeries are performed after preoperative fasting >6 hrs. as recommended by different society of anesthesiology. Moreover, fasting continues throughout surgery and few post-operative hours which usually lasts more than 12 hours. Also group of people after major abdominal surgeries frequently develop post-operative hyperbilirubinemia. All these factors after any major surgeries may pose a risk for the development of Gall stones. The major goal of this study is to look if the history of major surgery in the past is one of the etiological factors for the development of gall stone disease. It is a case-control study carried out in the Department of Surgery. It will also help us analyze other multiple epidemiological factors like age, sex, BMI, drugs, lipid profile, family history lifestyle, and dietary factors associated with the disease. The epidemiological data from this study can also help us analyze other confounding and determining factors.

NCT ID: NCT04672902 Completed - Cholelithiasis Clinical Trials

Treatment of Mirizzi Syndrome

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

Mirizzi syndrome is an infrequent complication of long-standing cholelithiasis. Extrinsic compression of the common hepatic duct is usually caused by an impacted stone in Hartmann's pouch or cystic duct resulting in the development of cholecystobiliary fistula. This syndrome is classified based on the presence and severity of cholecystobiliary fistula. Mirizzi syndrome is challenging to diagnose preoperatively and may require complex biliary surgical procedures for resolution. Endoscopic treatment is a safe alternative with a high success rate. Single-operator cholangioscopy combined with lithotripsy has been shown to have a 90-100% success rate in the treatment of biliary stones. Herein, A single center experience treating Mirizzi syndrome with single-operator cholangioscopy guided electrohydraulic lithotripsy is presented. Difficult management of Mirizzi syndrome has led to research of new treatment options to minimize the risk of high rate complications. Single-operator cholangioscopy in combination with laser lithotripsy is an adequate and safe alternative for the treatment of this condition.

NCT ID: NCT04670952 Recruiting - Clinical trials for Cholecystitis; Gallstone

Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients

POPLOP
Start date: June 10, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04456218 Completed - Neoplasms Clinical Trials

Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct stone or neoplasm. This system consists of a camera, light sources, a working channel, and a water injection channel. The endoscope could be inserted into the common bile duct via the working channel of a commercial duodenoscope. This study aims to test the feasibility and safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.