Gallstone Clinical Trial
Official title:
A Prospective, Randomized Controlled Trial of the Comparative Analysis Between Motilitone and Gasmotin for the Symptom Relief in Gallstone Patients With Functional Dyspepsia
- (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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | September 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 74 Years |
Eligibility |
Inclusion Criteria: 1. 19 years old to under 75 2. Patients with dyspepsia in patients with cholelithiasis 3. Patients who consented to this study and conducted questionnaires and tests during follow up Exclusion Criteria: 1. asymptomatic cholelithiasis 2. Gallstones over 3cm 3. Acute cholecystitis requires surgery 4. pregnant women 5. porcelain gallbladder 6. Chronic cholecystitis with severe thickening of the gallbladder wall 7. Patients with anomalous pancreato-biliary duct union, 8. When other physicians believe that surgery is necessary 9. Patients with a history of hypersensitivity to "motilitone" or its components ; Since this drug contains lactose, galactose intolerance, Patients with genetic problems such as Lapp lactase deficiency or glucose-galactose malabsorption. 10. Hepatitis patients (Hepatitis carriers, cirrhosis patients) or suspected liver failure (AST, ALT levels are 1.5 times or more of normal values) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Surgery, Severance hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Catnach SM, Ballinger AB, Stevens M, Fairclough PD, Trembath RC, Drury PL, Watkins PJ. Erythromycin induces supranormal gall bladder contraction in diabetic autonomic neuropathy. Gut. 1993 Aug;34(8):1123-7. — View Citation
Sengupta S, Modak P, McCauley N, O'Donnell LJ. Prokinetic effect of alpha-adrenergic antagonist, and beta-adrenergic antagonist on gall-bladder motility in humans with gall-stone disease. Eur J Gastroenterol Hepatol. 2007 Jul;19(7):581-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Check symptom improvement | The symptom score check should be completed at the first outpatient visit 3 months after administration. Nepean Dyspepsia Index- Korean version will be used to check the patient's indigestion symptoms. The questionnaire contains the following gastrointestinal symptoms How often it happened / how severe the symptoms were / how much it bothered you There are five (or six) answers. Gastrointestinal symptoms included Abdominal pain, Abdominal discomfort, Having a sour stomach, Heart burn, A Spasm of the stomach, Chest pain, Early fullness, Gastric acid reflux, Satiety after eating, pressure in the upper abdomen, Bloating of the upper abdomen, Nausea, Vomiting, Burp, Hard to breathe. The answer can be selected in 5 (6) numbers; from 0 to 4 (5). We will check the total score with the sum of each score. The symptom score is compared before and 3 months after administration. | 3months (At the first outpatient visit 3months after administration) | |
Primary | Changes in serum concentrations of WBC count (10^3/µL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of RBC count (10^6/µL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of Hemoglobin (g/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of BUN (mg/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of Glucose (mg/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of Albumin (g/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of Total bilirubin (mg/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of Direct bilirubin (mg/dL), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of Amylase (U/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of Lipase (U/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of Sodium (mmol/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of Potassium (mmol/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of liver enzymes (aspartate aminotransferase and alanine aminotransferase (IU/L)), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of Alkaline phosphate (IU/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Primary | Changes in serum concentrations of Gamma-glutamyltransferase (IU/L), before and after the administration | 3months (At the first outpatient visit 3months after administration) | ||
Secondary | Abdominal ultrasound examination - Change of Gallbladder wall thickening | We will check Abdominal ultrasound examination 6months after administration. Ultrasonography checks whether the gallbladder wall is thick or not. The ultrasound findings are compared before and 6 months after administration. | 6months (At the second outpatient visit 6months after administration) | |
Secondary | Abdominal ultrasound examination - Gallbladder wall extent | We will check Abdominal ultrasound examination 6months after administration. If the gallbladder wall was thick at the first visit, ultrasound after 6 months checks how thick the gallbladder wall is. The thickness of the gallbladder wall is confirmed by mm from ultrasound findings. The ultrasound findings are compared before and 6 months after administration. | 6months (At the second outpatient visit 6months after administration) | |
Secondary | Abdominal ultrasound examination - Number of gallstones | We will check Abdominal ultrasound examination 6months after administration. Ultrasonography checks the number of gallstones. The ultrasound findings are compared before and 6 months after administration. | 6months (At the second outpatient visit 6months after administration) | |
Secondary | Abdominal ultrasound examination - Maximum diameter of gallstones | We will check Abdominal ultrasound examination 6months after administration. Ultrasonography checks the maximum diameter of gallstones. The maximum diameter of gallstones is confirmed by mm from ultrasound findings. The ultrasound findings are compared before and 6 months after administration. | 6months (At the second outpatient visit 6months after administration) | |
Secondary | Abdominal ultrasound examination - Presence or Absence of sludge | We will check Abdominal ultrasound examination 6months after administration. Ultrasonography checks whether the sludge is in the gallbladder or not. The ultrasound findings are compared before and 6 months after administration. | 6months (At the second outpatient visit 6months after administration) |
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