Clinical trial NCT04960189: GB34 Acupuncture in Acute Cholecystitis
Official title: GB34 Acupuncture as Adjuvant in Early Phase of Medical Treatment of Mild Acute Cholecystitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Cholecystitis
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Perceived pain
timeFrame: Through study completion, an average of 1 year
measure: Guarding
timeFrame: Through study completion, an average of 1 year
measure: Rebound
timeFrame: Through study completion, an average of 1 year
measure: Hb
timeFrame: Through study completion, an average of 1 year
measure: WBC
timeFrame: Through study completion, an average of 1 year
measure: NEU%
timeFrame: Through study completion, an average of 1 year
measure: LYM%
timeFrame: Through study completion, an average of 1 year
measure: PLT
timeFrame: Through study completion, an average of 1 year
measure: CRP
timeFrame: Through study completion, an average of 1 year
measure: AST
timeFrame: Through study completion, an average of 1 year
measure: ALT
timeFrame: Through study completion, an average of 1 year
measure: ALP
timeFrame: Through study completion, an average of 1 year
measure: GGT
timeFrame: Through study completion, an average of 1 year
measure: Amylase
timeFrame: Through study completion, an average of 1 year
measure: Total bilirubin
timeFrame: Through study completion, an average of 1 year
measure: Direct bilirubin
timeFrame: Through study completion, an average of 1 year
measure: Oral intake
timeFrame: Through study completion, an average of 1 year
measure: Analgesic dosage
timeFrame: Through study completion, an average of 1 year
measure: Antibiotic dosage
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Niğde Ömer Halisdemir University Training and Research Hospital
Study officials:
affiliation: Niğde Ömer Halisdemir University
name: Alirıza Erdoğan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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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.
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.