Clinical trial NCT02156947: Correlation Between Power Doppler and Intraoperative Findings of Chronic and Acute Cholecystitis
Official title: Correlation Between Preoperative Power Doppler Sonography and Intraoperative Findings - Postoperative Outcomes of Chronic and Acute Cholecystitis Patients: Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cholecystitis With Chronic Cholecystitis
Keywords: Power Doppler sonography
cholecystitis, adhesion
Lead sponsor: Samsun Education and Research Hospital
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 80 cholecystitis patients (40 symptomatic chronic, 40 acute).

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between wall thickness-vascularity and adhesion grade
timeFrame: Up to ten days
Secondary outcomes:
measure: Correlation between vascularity and gallbladder perforation
timeFrame: Up to ten days
measure: Correlation between vascularity and convertion
timeFrame: Up to ten days
measure: Correlation between vascularity and operation time
timeFrame: Up to ten days
measure: Correlation between vascularity and drain usage
timeFrame: Up to ten days
measure: Correlation between vascularity and specimen
timeFrame: Up to twenty days
measure: Correlation between wall thickness and specimen
timeFrame: Up to twenty days
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana Numune Education and Research Hospital, Adana, Turkey
Study officials:
affiliation: Samsun Education and Research Hospital
name: Recep Aktimur
role: STUDY_DIRECTOR
References:
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. doi: 10.1148/radiology.155.3.3890007.
citation: 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.
citation: 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.
citation: 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.