- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02156947
Correlation Between Power Doppler and Intraoperative Findings of Chronic and Acute Cholecystitis
Correlation Between Preoperative Power Doppler Sonography and Intraoperative Findings - Postoperative Outcomes of Chronic and Acute Cholecystitis Patients: Prospective Clinical Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Gray-scale sonography is generally considered as a first-line diagnostic tool for patients with suspected gallbladder (GB) diseases. Once the gallstone is detected in a patient who is complaining abdominal pain in the right upper quadrant, the second concern is to differential diagnosis, biliary colic or acute cholecystitis. Certain diagnosis of acute cholecystitis is important, because of these two entity require different treatments. Gray-scale sonography has proven to be a valuable imaging technique in differential diagnosis for acute or chronic cholecystitis (1). In the presence of gallstones, sonographic findings such as GB wall thickening and the Murphy's sign has 90% sensitivity for the diagnosis of acute cholecystitis (2). On the other hand, abdominal pain and accompanying GB wall thickening can be seen in different clinical scenarios such as, pancreatitis, hepatitis, cirrhosis, and congestive heart failure. Thus, the specificity of these sonographic findings are not as high as their sensitivity. To eliminate this diagnostic concern, the need for correlation between diagnostic tool and disease physiopathology was realized. The GB wall is thickened and the vascularisation is increased in acute cholecystitis, but in the chronic cholecystitis the thickening of the GB wall is caused by fibrosis. This pathologic difference is to key point of distinguishing between acute and chronic cholecystitis. Determining the vascularisation of the GB wall with Doppler sonography was showed valuable diagnostic benefits, and the diagnostic superiority was obtained especially with power Doppler sonography (3).
Today, laparoscopic cholecystectomy (LC) has become the gold standard treatment for benign biliary diseases. Although, the laparoscopic approach to acute cholecystitis have a lot of advantages, such as; less postoperative pain, shorter hospital stay and better cosmetic results, timing of the operation and intraoperative findings of GB wall inflammation and adhesions are critical for performing a safe cholecystectomy. The risk of bleeding and bile duct injury are significantly increases in the presence of severe inflammation and adhesions (4). These findings may lead surgeon to convert LC to an open cholecystectomy.
In theory, increased vascularity of GB wall could be associated with intraoperative findings, such as, GB wall inflammation and accompanying adhesions. There are not enough reports in the literature describing the correlation between GB wall vascularity and operative findings according to adhesion scoring scale. In this prospective clinical study, we aimed to highlight the correlation between preoperative power Doppler sonography detected GB wall vascularity and intraoperative findings - postoperative outcomes of chronic and acute cholecystitis patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Adana, Turkey
- Adana Numune Education and Research Hospital, Adana, Turkey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Symptomatic chronic cholelithiasis patients, who were accepted to laparoscopic cholecystectomy
- Acute cholelithiasis patients, who were accepted to laparoscopic cholecystectomy in first 72-96 hours (from the onset of symptoms), Acute cholecystitis diagnosis was made according to; acute right upper quadrant abdominal pain with positive Murphy's sign, fever, leukocytosis and sonographically; distended GB, presence of gallstones or sludge, GB wall thickness of 3-mm or more, sonographic Murphy's sign.
Exclusion Criteria:
- Choledocholithiasis
- <18 years old
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Chronic cholecystitis
Laparoscopic cholecystectomy was performed.
Gallbladder adhesion score and intraoperative findings of patients were assessed.
Adhesion score, gallbladder perforation during the dissection, convertion to open cholecystectomy, operation time, drain usage and intraoperative complications were recorded.
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The technique used for LC was the conventional four-trocar approach (10-mm optic at the umbilicus, 10-mm trocar in the epigastrium and two 5-mm trocars in the right upper abdomen).
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Acute cholecystitis
Laparoscopic cholecystectomy was performed.
Gallbladder adhesion score and intraoperative findings of patients were assessed.
Adhesion score, gallbladder perforation during the dissection, convertion to open cholecystectomy, operation time, drain usage and intraoperative complications were recorded.
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The technique used for LC was the conventional four-trocar approach (10-mm optic at the umbilicus, 10-mm trocar in the epigastrium and two 5-mm trocars in the right upper abdomen).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between wall thickness-vascularity and adhesion grade
Time Frame: Up to ten days
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Correlation between gallbladder wall thickness - vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and intraoperative adhesion grade (as measured by gallbladder adhesion scoring scale) of chronic and acute cholecystitis patients.
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Up to ten days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between vascularity and gallbladder perforation
Time Frame: Up to ten days
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Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and intraoperative gallbladder perforation
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Up to ten days
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Correlation between vascularity and convertion
Time Frame: Up to ten days
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Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and convertion to open cholecystectomy
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Up to ten days
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Correlation between vascularity and operation time
Time Frame: Up to ten days
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Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and operation time
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Up to ten days
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Correlation between vascularity and drain usage
Time Frame: Up to ten days
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Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and drain usage
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Up to ten days
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Correlation between vascularity and specimen
Time Frame: Up to twenty days
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Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and pathologic assessment of specimen
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Up to twenty days
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Correlation between wall thickness and specimen
Time Frame: Up to twenty days
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Correlation between gallbladder wall thickness and pathologic assessment of specimen
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Up to twenty days
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Collaborators and Investigators
Investigators
- Study Director: Recep Aktimur, Samsun Education and Research Hospital
Publications and helpful links
General Publications
- Ralls PW, Colletti PM, Lapin SA, Chandrasoma P, Boswell WD Jr, Ngo C, Radin DR, Halls JM. Real-time sonography in suspected acute cholecystitis. Prospective evaluation of primary and secondary signs. Radiology. 1985 Jun;155(3):767-71. doi: 10.1148/radiology.155.3.3890007.
- Uggowitzer M, Kugler C, Schramayer G, Kammerhuber F, Groll R, Hausegger KA, Ratschek M, Quehenberger F. Sonography of acute cholecystitis: comparison of color and power Doppler sonography in detecting a hypervascularized gallbladder wall. AJR Am J Roentgenol. 1997 Mar;168(3):707-12. doi: 10.2214/ajr.168.3.9057520.
- Akoglu M, Ercan M, Bostanci EB, Teke Z, Parlak E. Surgical outcomes of laparoscopic cholecystectomy in scleroatrophic gallbladders. Turk J Gastroenterol. 2011;22(2):183-9. doi: 10.4318/tjg.2011.0188.
- Cetinkunar S, Erdem H, Aktimur R, Soker G, Bozkurt H, Reyhan E, Sozen S, Irkorucu O. Evaluation of power Doppler sonography in acute cholecystitis to predict intraoperative findings: a prospective clinical study. Ulus Travma Acil Cerrahi Derg. 2015 Jan;21(1):51-6. doi: 10.5505/tjtes.2015.64505.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Doppler-Acute cholecystitis (Other Identifier: Adana Numune Education and Research Hospital)
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