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

Acute Cholecystitis With Chronic Cholecystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156947
• Other study ID #: Doppler-Acute Cholecystitis
• Secondary ID: Doppler-Acute ch
• Status: Completed
• Phase: N/A
• First received: June 1, 2014
• Last updated: June 3, 2014
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2014
• Source: Samsun Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Cholecystitis With Chronic Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Laparoscopic cholecystectomy
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).

Locations

Country	Name	City	State
Turkey	Adana Numune Education and Research Hospital, Adana, Turkey	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Samsun Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

Uggowitzer M, Kugler C, Schramayer G, Kammerhuber F, Gröll 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between wall thickness-vascularity and adhesion grade	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	No
Secondary	Correlation between vascularity and gallbladder perforation	Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and intraoperative gallbladder perforation	Up to ten days	Yes
Secondary	Correlation between vascularity and convertion	Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and convertion to open cholecystectomy	Up to ten days	Yes
Secondary	Correlation between vascularity and operation time	Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and operation time	Up to ten days	No
Secondary	Correlation between vascularity and drain usage	Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and drain usage	Up to ten days	Yes
Secondary	Correlation between vascularity and specimen	Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and pathologic assessment of specimen	Up to twenty days	No
Secondary	Correlation between wall thickness and specimen	Correlation between gallbladder wall thickness and pathologic assessment of specimen	Up to twenty days	No