GB34 Acupuncture in Acute Cholecystitis
Primary Purpose
Acute Cholecystitis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholecystitis
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
Sites / Locations
- Niğde Ömer Halisdemir University Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Acupuncture
Controls
Arm Description
GB34 acupuncture will be applied every day. Patients will receive standard medical treatment
Patients will only receive standard medical treatment
Outcomes
Primary Outcome Measures
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.
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.
Rebound
presence or absence of abdominal rebound assessed by investigators. Rebound tenderness refers to pain or discomfort after pressing on the patient's abdomen .
Hb
Hemoglobin values expressed as g/dL
WBC
White blood cell count in microliter
NEU%
percent of neutrophils
LYM%
percent of lymphocytes
PLT
platelet count in microliter
CRP
C-reactive protein levels expressed in mg/L
AST
Aspartate aminotransferase levels expressed in IU/L
ALT
Alanine aminotransferase levels expressed in U/L
ALP
Alkaline phosphatase levels expressed in U/L
GGT
Gamma glutamyl transferase levels expressed in U/L
Amylase
Amylase levels expressed in U/L
Total bilirubin
Total bilirubin levels expressed in mg/dL
Direct bilirubin
Direct bilirubin levels expressed in mg/dL
Oral intake
if patients tolerate oral intake or not
Analgesic dosage
Total dosage of analgesic administered in mg
Antibiotic dosage
Total dosage of antibiotic administered in mg
Secondary Outcome Measures
Full Information
NCT ID
NCT04960189
First Posted
July 6, 2021
Last Updated
July 14, 2021
Sponsor
Nigde Omer Halisdemir University
1. Study Identification
Unique Protocol Identification Number
NCT04960189
Brief Title
GB34 Acupuncture in Acute Cholecystitis
Official Title
GB34 Acupuncture as Adjuvant in Early Phase of Medical Treatment of Mild Acute Cholecystitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nigde Omer Halisdemir University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
GB34 acupuncture will be applied every day. Patients will receive standard medical treatment
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Patients will only receive standard medical treatment
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived pain
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Guarding
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Rebound
Description
presence or absence of abdominal rebound assessed by investigators. Rebound tenderness refers to pain or discomfort after pressing on the patient's abdomen .
Time Frame
Through study completion, an average of 1 year
Title
Hb
Description
Hemoglobin values expressed as g/dL
Time Frame
Through study completion, an average of 1 year
Title
WBC
Description
White blood cell count in microliter
Time Frame
Through study completion, an average of 1 year
Title
NEU%
Description
percent of neutrophils
Time Frame
Through study completion, an average of 1 year
Title
LYM%
Description
percent of lymphocytes
Time Frame
Through study completion, an average of 1 year
Title
PLT
Description
platelet count in microliter
Time Frame
Through study completion, an average of 1 year
Title
CRP
Description
C-reactive protein levels expressed in mg/L
Time Frame
Through study completion, an average of 1 year
Title
AST
Description
Aspartate aminotransferase levels expressed in IU/L
Time Frame
Through study completion, an average of 1 year
Title
ALT
Description
Alanine aminotransferase levels expressed in U/L
Time Frame
Through study completion, an average of 1 year
Title
ALP
Description
Alkaline phosphatase levels expressed in U/L
Time Frame
Through study completion, an average of 1 year
Title
GGT
Description
Gamma glutamyl transferase levels expressed in U/L
Time Frame
Through study completion, an average of 1 year
Title
Amylase
Description
Amylase levels expressed in U/L
Time Frame
Through study completion, an average of 1 year
Title
Total bilirubin
Description
Total bilirubin levels expressed in mg/dL
Time Frame
Through study completion, an average of 1 year
Title
Direct bilirubin
Description
Direct bilirubin levels expressed in mg/dL
Time Frame
Through study completion, an average of 1 year
Title
Oral intake
Description
if patients tolerate oral intake or not
Time Frame
Through study completion, an average of 1 year
Title
Analgesic dosage
Description
Total dosage of analgesic administered in mg
Time Frame
Through study completion, an average of 1 year
Title
Antibiotic dosage
Description
Total dosage of antibiotic administered in mg
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alirıza Erdoğan, MD
Phone
05333558377
Email
alirizaerdogan@ohu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alirıza Erdoğan, MD
Organizational Affiliation
Niğde Ömer Halisdemir University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Niğde Ömer Halisdemir University Training and Research Hospital
City
Niğde
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alirıza Erdoğan, MD
Phone
05333558377
Email
alirizaerdogan@ohu.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31768828
Citation
Bouassida M, Zribi S, Krimi B, Laamiri G, Mroua B, Slama H, Mighri MM, M'saddak Azzouz M, Hamzaoui L, Touinsi H. C-reactive Protein Is the Best Biomarker to Predict Advanced Acute Cholecystitis and Conversion to Open Surgery. A Prospective Cohort Study of 556 Cases. J Gastrointest Surg. 2020 Dec;24(12):2766-2772. doi: 10.1007/s11605-019-04459-8. Epub 2019 Nov 25.
Results Reference
background
PubMed Identifier
28740954
Citation
Arer IM, Yabanoglu H, Caliskan K. Can red cell distribution width be used as a predictor of acute cholecystitis? Turk J Surg. 2017 Jun 1;33(2):76-79. doi: 10.5152/turkjsurg.2017.3392. eCollection 2017.
Results Reference
background
PubMed Identifier
26237977
Citation
Zhou ML, Jia WR, Wang JT, Wang P, Guo LH, Sui MH. [Effect of Electroacupuncture at "Yanglingquan" (GB 34) Acupoint on White Blood Cell Count and Gallbladder Wall Thickness in Rabbits with Acute Cholecystitis]. Zhen Ci Yan Jiu. 2015 Jun;40(3):233-7. Chinese.
Results Reference
background
PubMed Identifier
25220656
Citation
Yeo S, Choe IH, van den Noort M, Bosch P, Jahng GH, Rosen B, Kim SH, Lim S. Acupuncture on GB34 activates the precentral gyrus and prefrontal cortex in Parkinson's disease. BMC Complement Altern Med. 2014 Sep 15;14:336. doi: 10.1186/1472-6882-14-336.
Results Reference
background
PubMed Identifier
19666085
Citation
Na BJ, Jahng GH, Park SU, Jung WS, Moon SK, Park JM, Bae HS. An fMRI study of neuronal specificity of an acupoint: electroacupuncture stimulation of Yanglingquan (GB34) and its sham point. Neurosci Lett. 2009 Oct 16;464(1):1-5. doi: 10.1016/j.neulet.2009.08.009. Epub 2009 Aug 8.
Results Reference
background
PubMed Identifier
8569551
Citation
Andersson S, Lundeberg T. Acupuncture--from empiricism to science: functional background to acupuncture effects in pain and disease. Med Hypotheses. 1995 Sep;45(3):271-81. doi: 10.1016/0306-9877(95)90117-5.
Results Reference
background
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GB34 Acupuncture in Acute Cholecystitis
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