Correlation Between Power Doppler and Intraoperative Findings of Chronic and Acute Cholecystitis

June 3, 2014 updated by: Recep Aktimur, Samsun Education and Research Hospital

Correlation Between Preoperative Power Doppler Sonography and Intraoperative Findings - Postoperative Outcomes of Chronic and Acute Cholecystitis Patients: Prospective Clinical Study

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 Overview

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

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Adana, Turkey
        • Adana Numune Education and Research Hospital, Adana, Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 80 cholecystitis patients (40 symptomatic chronic, 40 acute).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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).
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.
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).

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
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.
Up to ten days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between vascularity and gallbladder perforation
Time Frame: Up to ten days
Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and intraoperative gallbladder perforation
Up to ten days
Correlation between vascularity and convertion
Time Frame: Up to ten days
Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and convertion to open cholecystectomy
Up to ten days
Correlation between vascularity and operation time
Time Frame: Up to ten days
Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and operation time
Up to ten days
Correlation between vascularity and drain usage
Time Frame: Up to ten days
Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and drain usage
Up to ten days
Correlation between vascularity and specimen
Time Frame: Up to twenty days
Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and pathologic assessment of specimen
Up to twenty days
Correlation between wall thickness and specimen
Time Frame: Up to twenty days
Correlation between gallbladder wall thickness and pathologic assessment of specimen
Up to twenty days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Recep Aktimur, Samsun Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 1, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • Doppler-Acute cholecystitis (Other Identifier: Adana Numune Education and Research Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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