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Completed

NCT Number: NCT04960189

GB34 Acupuncture in Acute Cholecystitis

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.

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Niğde Ömer Halisdemir University Training and Research Hospital

Niğde, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Procedure

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 outcomes

  1. Perceived pain

    Time frame: From hospital admission (baseline) until hospital discharge, with VAS assessments performed every 12 hours, assessed up to a maximum of 168 hours.

    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.

  2. Analgesic dosage

    Time frame: From hospital admission (baseline) until hospital discharge, assessed up to a maximum of 168 hours.

    Total dosage of analgesic administered in mg

Secondary outcomes

  1. Guarding

    Time frame: At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.

    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.

  2. Abdominal tenderness

    Time frame: At hospital admission (baseline) and every 24 hours until hospital discharge, assessed up to a maximum of 168 hours.

    presence or absence of abdominal tenderness assessed by investigators. Rebound tenderness refers to pain or discomfort after pressing on the patient's abdomen .

  3. Oral intake

    Time frame: From hospital admission (baseline) until first tolerated oral intake, assessed up to hospital discharge (maximum 168 hours).

    if patients tolerate oral intake or not

  4. Antibiotic dosage

    Time frame: From hospital admission (baseline) through hospital discharge, assessed up to a maximum of 168 hours

    Total antibiotic dose administered during hospitalization (mg)

  5. Direct bilirubin

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    Direct bilirubin levels expressed in mg/dL

  6. Total bilirubin

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    Total bilirubin levels expressed in mg/dL

  7. Amylase

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    Amylase levels expressed in U/L

  8. GGT

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    Gamma glutamyl transferase levels expressed in U/L

  9. ALP

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    Alkaline phosphatase levels expressed in U/L

  10. ALT

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    Alanine aminotransferase levels expressed in U/L

  11. AST

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    Aspartate aminotransferase levels expressed in IU/L

  12. CRP

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    C-reactive protein levels expressed in mg/L

  13. PLT

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    platelet count in microliter

  14. LYM%

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    percent of lymphocytes

  15. NEU%

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    percent of neutrophils

  16. WBC

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    White blood cell count in microliter

  17. Hb

    Time frame: At hospital admission (baseline) and every 48 hours until hospital discharge, assessed up to a maximum of 168 hours

    Hemoglobin values expressed as g/dL

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 13, 2021
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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