Brief Title
GB34 Acupuncture in Acute Cholecystitis
Official Title
GB34 Acupuncture as Adjuvant in Early Phase of Medical Treatment of Mild Acute Cholecystitis
Brief Summary
The purpose of this pilot study is to investigate the effects of GB34 acupuncture, performed
as adjuvant to standard medical treatment, on clinical response and laboratory parameters of
patients with a diagnosis of acute cholecystitis.
Detailed Description
Acute cholecystitis is a frequent complication of gallbladder stones. The prevalence of
gallbladder stone is 10-15% and in 35% of patients complications and recurrent symptoms
develop in their lifetime. Acute cholecystitis is one of the most frequently encountered
acute surgical conditions. It is manifested in 3-10% of patients referred to emergency
departments with complaints of abdominal pain.
Although the gold standard of therapy is laparoscopic cholecystectomy in symptomatic
cholecystitis and related complications, more than 70% of patients respond well to medical
treatment at first place. Actually, timing of cholecystectomy was studied extensively, yet is
still debatable. Early cholecystectomy is the operation performed within 72 hours of the
beginning of the symptoms. Delayed cholecystectomy is the operation performed 6 weeks after
the suppression of the inflammation. Investigators perform early cholecystectomy is in cases
with perforation and complication like gangrenous or emphysematous acute cholecystitis
whereas delayed cholecystectomy is preferred in the remaining patients.
In fact it is known for some time that ear and body acupuncture have modulatory effects on
motor functions of gallbladder and even provide some improvement in acute cholecystitis.
Previously, studies demonstrating that GB34 has specific effects on the motility of bile
ducts were published. More recently, researchers were able to demonstrate that GB34 electro
acupuncture have positive effects on gall bladder wall thickness and on WBC levels, by using
an experimental rabbit model of acute cholecystitis. Additional functional MR studies were
used to distinguish the neural specificity of the acupuncture points. GB34 were found to
induce a specific response pattern which is more significant in motor functions in brain.
Furthermore it is known for decades that acupuncture other than point specific effects,
triggers self-healing mechanisms of the body via endogen pathways.
Study Type
Interventional
Primary Outcome
Perceived pain
Condition
Acute Cholecystitis
Intervention
Acupuncture
Study Arms / Comparison Groups
Acupuncture
Description: GB34 acupuncture will be applied every day. Patients will receive standard medical treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
30
Start Date
July 1, 2021
Completion Date
July 1, 2022
Primary Completion Date
July 1, 2022
Eligibility Criteria
Inclusion Criteria:
- Diagnosed and hospitalised patients with mild acute cholecystitis
Exclusion Criteria:
- Pregnant women
- Immunosuppressive patients
- Patients with intermediate and severe acute cholecystitis
- Patients with acalculous acute cholecystitis
- Patients with uncontrolled diabetes mellitus
- Patients with collegen tissue diseases
- Patients with malignancies
- Patients who are using anti-coagulant or anti-aggregant medications
- Patients with blood diseases
- Patients with BMI>35
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Alirıza Erdoğan, MD, 05333558377, [email protected]
Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT04960189
Organization ID
08.06.2021/32
Responsible Party
Principal Investigator
Study Sponsor
Nigde Omer Halisdemir University
Study Sponsor
Alirıza Erdoğan, MD, Principal Investigator, Niğde Ömer Halisdemir University
Verification Date
July 2021