GB34 Acupuncture in Acute Cholecystitis

Acute Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04960189
• Other study ID #: 08.06.2021/32
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2021
• Source: Nigde Omer Halisdemir University
• Contact: Aliriza Erdogan, MD
• Phone: 05333558377
• Email: alirizaerdogan[@]ohu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Acupuncture
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.

Locations

Country	Name	City	State
Turkey	Nigde Ömer Halisdemir University Training and Research Hospital	Nigde

Sponsors (1)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

Arer IM, Yabanoglu H, Çaliskan 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Hb	Hemoglobin values expressed as g/dL	Through study completion, an average of 1 year
Primary	WBC	White blood cell count in microliter	Through study completion, an average of 1 year
Primary	NEU%	percent of neutrophils	Through study completion, an average of 1 year
Primary	LYM%	percent of lymphocytes	Through study completion, an average of 1 year
Primary	PLT	platelet count in microliter	Through study completion, an average of 1 year
Primary	CRP	C-reactive protein levels expressed in mg/L	Through study completion, an average of 1 year
Primary	AST	Aspartate aminotransferase levels expressed in IU/L	Through study completion, an average of 1 year
Primary	ALT	Alanine aminotransferase levels expressed in U/L	Through study completion, an average of 1 year
Primary	ALP	Alkaline phosphatase levels expressed in U/L	Through study completion, an average of 1 year
Primary	GGT	Gamma glutamyl transferase levels expressed in U/L	Through study completion, an average of 1 year
Primary	Amylase	Amylase levels expressed in U/L	Through study completion, an average of 1 year
Primary	Total bilirubin	Total bilirubin levels expressed in mg/dL	Through study completion, an average of 1 year
Primary	Direct bilirubin	Direct bilirubin levels expressed in mg/dL	Through study completion, an average of 1 year
Primary	Oral intake	if patients tolerate oral intake or not	Through study completion, an average of 1 year
Primary	Analgesic dosage	Total dosage of analgesic administered in mg	Through study completion, an average of 1 year
Primary	Antibiotic dosage	Total dosage of antibiotic administered in mg	Through study completion, an average of 1 year