Gallstones

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Gallstones

General Purpose:

The gallbladder is an organ roughly the size and shape of a pear, which is located on the right side of the abdomen, just below the liver. It holds bile, which is a liquid released into the small intestine to help digest dietary fat.

Occasionally, small deposits of bile can harden within the gallbladder, creating what are commonly known as gallstones. They can vary considerably in size, ranging from as small as a grain of sand to as large as a golf ball.

They can occur singularly or in groups. Although some gallstones may cause no symptoms at all, others can be incredibly painful. Symptoms include sudden, intense pain in the upper right abdominal area or just below the breastbone; pain between the shoulder blades; and pain in the right shoulder.

Individuals who have gallstones that are asymptomatic rarely require treatment; only those that lead to the development of symptoms typically require treatment. Complications of gallstones include gallbladder inflammation, blockage of the bile duct (which can lead to jaundice and infection), pancreatitis (inflammation of the pancreas), and cancer of the gallbladder.

No one knows for certain what causes gallstones to develop, but some doctors and researchers think they may occur as a result of too much cholesterol, excess bilirubin (a chemical produced by the liver to help break down red blood cells), or possibly due to inadequate emptying of the gallbladder. Although their exact cause is not known, a number of risk factors for the development of gallstones have been identified.

These include female gender; age 60 or over; American Indian, or Mexican-American heritage; overweight and obesity; pregnancy; diet high in fat and cholesterol, and low in fiber; family history of gallstones; diabetes; history of rapid weight loss; use of certain cholesterol-lowering medications; and hormone replacement therapies.

Gallstone-related research is currently focused on identifying better methods of treatment, more accurate means of diagnosis, and exploring efforts to prevent the development of gallstones.

What Will Gallstone Clinical Trials Be Like?

The types of tests and assessments used in clinical trials for gallstones will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests that may be incorporated into clinical trials:

  • Physical exam and detailed medical history
  • Blood tests to look for signs of infection
  • Computed tomography (CT, or “CAT scan”): an imaging procedure that uses an x-ray machine linked to a computer to take detailed pictures of areas inside the body.
  • Hepatobiliary iminodiacetic acid (HIDA) scan: a test that uses a special non-toxic dye which is injected into a vein. The dye then moves through the body and illuminates the areas it passes through to make them more visible when viewed on x-ray. This type of test can help doctors identify potential blockages.
  • Magnetic resonance imaging (MRI): a non-invasive imaging procedure similar to a CT scan that allows doctors to view incredibly detailed, computerized images of areas within the body.
  • Blood tests to look for signs of possible gallstone-related complications, including jaundice, infection, or pancreatitis.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as diet, exercise and/or medication diaries, may also be required in some studies, depending on the research question being studied.

Typical Gallstone Clinical Trial Protocol:

Specific examples of clinical trials for gallstones might include the following:

  • A randomized clinical trial to evaluate the safety and efficacy of a plant-based medicine when used to treat gallstones in individuals age 65 and over. In such a study, half of the patients would be randomly assigned to receive treatment with the medicine while the other half would receive a placebo.
  • An interventional study to determine the safety and efficacy of a new surgical approach to remove the gallbladder in individuals who suffer from severe gallstones. This study would test a surgical procedure never before attempted in humans, during which the gallbladder would be removed through a natural opening (i.e., the mouth, vagina, or rectum) rather than through a surgical incision.
  • An observational study in which individuals with a history of gallstones, and a family history of the condition, provide blood and tissue samples for analysis. The purpose of such a study would be to determine if individuals with a family history share any common genetic mutations that might be associated with an increased risk of gallbladder disease.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug or intervention, compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as in the first example provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your history of gallstones (age at onset, size of stones)
  • Any underlying illnesses you have
  • Your family history of gallstones and other gallbladder disease
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your history of treatment for gallstones

Suggested Search Terms:

Once you are ready to begin your search for gallstone clinical trials, the following terms may be of use when combined with “gallstones”: “prevention,” “management,” “treatment,” “diet,” “exercise,” “disease,” “elderly,” “side effects,” “medication,” “surgery,” and “diagnosis.”

Current Search Term:

“Gallstones”

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Study on the Learning Curve for Fundus First With Ultrasonic Tissue Coagulation in Elective Cholecystectomy


Condition:   Cholecystolithiasis
Intervention:   Device: Ultrasonic tissue coagulation dissection
Sponsor:   Karolinska Institutet
Recruiting - verified May 2017


Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction


Conditions:   Gallstone;   Cholecystolithiasis
Interventions:   Procedure: Endoscopic Balloon Sphincteroplasty;   Procedure: Laser Lithotripsy
Sponsor:   Florida Hospital
Recruiting - verified February 2017


Laparoscopic Cholecystectomy With Retro-infundibular Approach


Condition:   Gallstones
Interventions:   Procedure: standard laparoscopic cholecystectomy;   Procedure: RI approach
Sponsor:   Minia University
Completed - verified October 2016


Routine Nasobiliary Insertion During ERCP in High Risk Patients.


Condition:   Gallstones Complicated by CBD Stones
Interventions:   Procedure: ERCP with NB;   Procedure: ERCP alone
Sponsor:   Minia University
Completed - verified August 2016


3D Versus 4K Laparoscopic Cholecystectomy


Conditions:   Cholecystitis;   Gallstones
Interventions:   Procedure: 3D laparoscopy;   Procedure: 4K laparoscopy
Sponsor:   Royal Surrey County Hospital
Not yet recruiting - verified August 2016


Clinical Application of Cholangiojejunostomy in the Surgical Treatment of Cholelithiasis With Moderate Dilatation of Common Bile Duct


Conditions:   Cholangiojejunostomy;   Cholelithiasis
Interventions:   Procedure: cholangiojejunostomy;   Procedure: hepatectomy;   Device: T-tube
Sponsor:   Southwest Hospital, China
Recruiting - verified September 2016


The Risk Factors of Symptomatic Gallbladder Stone: Age-Sex Matched Case-control Study Performed in Single Institute


Condition:   Gallstone
Intervention:  
Sponsor:   Cheju Halla General Hospital
Completed - verified June 2016


Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis


Condition:   Pancreatitis
Interventions:   Procedure: Early cholecystectomy with IOC;   Procedure: Late cholecystectomy with IOC
Sponsor:   The University of Texas Health Science Center, Houston
Recruiting - verified October 2016


Multimedia Informed Consent & PROMs in Laparoscopic Cholecystectomy


Condition:   Gallstone Disease
Intervention:   Procedure: Laparoscopic cholecystectomy
Sponsors:   Nottingham University Hospitals NHS Trust;   EIDO Healthcare;   The Royal College of Surgeons of England
Recruiting - verified December 2016


Comparison of Post-operative Pain at Umbilical Wound After Laparoscopic Cholecystectomy With Transumbilical Versus Infraumbilical Incision


Conditions:   Pain, Postoperative;   Gallstone
Interventions:   Procedure: transumbilical incision;   Procedure: Infra umbilical incision
Sponsor:   Thammasat University
Recruiting - verified October 2016


Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?


Condition:   Cholelithiasis
Intervention:  
Sponsors:   Sisli Etfal Training & Research Hospital;   Bezmialem Vakif University;   Istanbul Training and Research Hospital;   Erzincan University;   Arnavutkoy State Hospital;   Bursa Yüksek İhtisas Education and Research Hospital
Active, not recruiting - verified October 2016


Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II


Condition:   Endoscopic Retrograde Cholangiopancreatography , Gallstone
Interventions:   Radiation: nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography;   Radiation: standard endoscopic retrograde cholangiopancreatography
Sponsor:   Fourth Military Medical University
Completed - verified July 2016


Optimization and Cost-effective Analysis of Secondary Biliary Stones' Managements


Conditions:   Gallstones;   Cholelithiasis;   Cholecystolithiasis;   Choledocholithiasis
Interventions:   Procedure: endoscopic sphincterotomy;   Procedure: laparoscopic common bile duct exploration;   Procedure: laparoscopic transcystic common bile duct exploration;   Procedure: laparoscopic cholecystectomy
Sponsors:   Beijing Friendship Hospital;   Peking University First Hospital;   Xuanwu Hospital, Beijing;   Luhe Hospital, Capital Medical University;   Peking University Third Hospital;   China-Japan Friendship Hospital;   Beijing Tongren Hospital;   Peking University
Recruiting - verified July 2016


Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer


Condition:   Gastric Cancer
Interventions:   Drug: DWJ1319;   Drug: Placebo
Sponsor:   Daewoong Pharmaceutical Co. LTD.
Recruiting - verified August 2016


Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy


Condition:   Gall Stones
Interventions:   Behavioral: relaxation program;   Behavioral: surgery education
Sponsor:   Universität Duisburg-Essen
Recruiting - verified May 2017


The Role of Ursodeoxycholic Acid in Treatment of Gallstones in Hemolytic Disorders


Conditions:   Hemolytic Disorders;   Gallstones
Intervention:   Drug: Ursodeoxycholic Acid
Sponsor:   Shaare Zedek Medical Center
Recruiting - verified June 2016


3D vs 2D HD Laparoscopy in Cholecystectomy


Condition:   Cholecystolithiasis
Interventions:   Procedure: 2D laparoscopic cholecystectomy;   Procedure: 3D laparoscopic cholecystectomy
Sponsor:   Helsinki University Central Hospital
Active, not recruiting - verified April 2017


Fluorescence Cholangiography During Cholecystectomy - a RCT


Conditions:   Cholecystitis;   Gallstones
Interventions:   Drug: Indocyanine green;   Device: Near-infrared illumination;   Drug: Urografin;   Radiation: X-ray
Sponsor:   Hvidovre University Hospital
Enrolling by invitation - verified November 2016


Radiological Investigation of Bile Duct Obstruction


Condition:   Gallstone Disease
Interventions:   Procedure: Cholecystectomy and intraoperative cholangiography;   Procedure: Magnet resonance cholangio-pancreaticography;   Device: magnet resonance imaging;   Device: catheter
Sponsors:   University Hospital, Basel, Switzerland;   Clinical Trial Unit, University Hospital Basel, Switzerland
Recruiting - verified August 2016


Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery


Condition:   Morbid Obesity
Interventions:   Drug: URSODIOL;   Drug: Placebo
Sponsor:   HaEmek Medical Center, Israel
Recruiting - verified March 2017


Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy


Condition:   Gall Stone Disease
Interventions:   Drug: Lidocaine;   Drug: Esmolol;   Drug: Paracetamol;   Drug: Lidocaine;   Drug: Propofol;   Drug: Fentanyl;   Drug: Vecuronium;   Drug: Atropine;   Drug: Ephedrine;   Drug: Morphine;   Drug: Ketorolac;   Drug: Ondansetron;   Drug: Bupivacaine;   Drug: Tramadol;   Drug: Neostigmine;   Drug: Glycopyrrolate
Sponsor:   B.P. Koirala Institute of Health Sciences
Completed - verified November 2016


Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy


Condition:   Common Bile Duct Gall Stones
Intervention:   Procedure: Common bile duct stone removal without fluoroscopy.
Sponsors:   California Pacific Medical Center Research Institute;   University of California, Los Angeles;   Northwestern University
Completed - verified July 2016


Obeticholic Acid in Bariatric and Gallstone Disease


Conditions:   Obesity;   Gallstones
Interventions:   Drug: Obeticholic acid;   Drug: Placebo
Sponsors:   Sahlgrenska University Hospital, Sweden;   Medical University of Vienna
Completed - verified October 2016


Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones


Condition:   Gall Stones
Interventions:   Procedure: Laser Lithotripsy;   Procedure: Electrohydraulic Lithotripsy
Sponsor:   The Cleveland Clinic
Completed - verified March 2017


Minimally Invasive Surgery: Using Natural Orfices


Conditions:   Appendicitis;   Cholelithiasis;   Gallstones
Interventions:   Procedure: Transvaginal Appendectomy;   Procedure: Transvaginal Cholecystectomy
Sponsor:   University of California, San Diego
Recruiting - verified October 2016

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