GB34 Acupuncture in Acute Cholecystitis

Study Overview
=================
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.

Official Title
-----------------
GB34 Acupuncture as Adjuvant in Early Phase of Medical Treatment of Mild Acute Cholecystitis

Conditions
-----------------
Acute Cholecystitis

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>GB34 acupuncture will be applied every day. Patients will receive standard medical treatment | Procedure: Acupuncture<br>* Acupuncture will be performed bilateral on fibular aspect of the leg, in the depression anterior and distal to the head of the fibula by using 0,25x50mm needles.<br>|
| No Intervention: Controls<br>Patients will only receive standard medical treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived pain | Measured by Visual Analog Scale scored between 0 and 10. Zero refers to no pain whereas 10 refers to the worst pain perceived by the patient. | Through study completion, an average of 1 year | 
| Guarding | presence or absence of abdominal guarding assessed by investigators. Guarding is defined as a spasm of muscles that minimizes the motion or agitation of sites that are affected by injury or disease. | Through study completion, an average of 1 year | 
| Rebound | presence or absence of abdominal rebound assessed by investigators. Rebound tenderness refers to pain or discomfort after pressing on the patient's abdomen . | Through study completion, an average of 1 year | 
| Hb | Hemoglobin values expressed as g/dL | Through study completion, an average of 1 year | 
| WBC | White blood cell count in microliter | Through study completion, an average of 1 year | 
| NEU% | percent of neutrophils | Through study completion, an average of 1 year | 
| LYM% | percent of lymphocytes | Through study completion, an average of 1 year | 
| PLT | platelet count in microliter | Through study completion, an average of 1 year | 
| CRP | C-reactive protein levels expressed in mg/L | Through study completion, an average of 1 year | 
| AST | Aspartate aminotransferase levels expressed in IU/L | Through study completion, an average of 1 year | 
| ALT | Alanine aminotransferase levels expressed in U/L | Through study completion, an average of 1 year | 
| ALP | Alkaline phosphatase levels expressed in U/L | Through study completion, an average of 1 year | 
| GGT | Gamma glutamyl transferase levels expressed in U/L | Through study completion, an average of 1 year | 
| Amylase | Amylase levels expressed in U/L | Through study completion, an average of 1 year | 
| Total bilirubin | Total bilirubin levels expressed in mg/dL | Through study completion, an average of 1 year | 
| Direct bilirubin | Direct bilirubin levels expressed in mg/dL | Through study completion, an average of 1 year | 
| Oral intake | if patients tolerate oral intake or not | Through study completion, an average of 1 year | 
| Analgesic dosage | Total dosage of analgesic administered in mg | Through study completion, an average of 1 year | 
| Antibiotic dosage | Total dosage of antibiotic administered in mg | Through study completion, an average of 1 year |