Acute Cholecystitis With Chronic CholecystitisNCT02156947
Correlation Between Power Doppler and Intraoperative Findings of Chronic and Acute Cholecystitis
An observational study of Acute Cholecystitis With Chronic Cholecystitis, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis With Chronic Cholecystitis
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 80 cholecystitis patients (40 symptomatic chronic, 40 acute).
Who may be able to join
- 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.
Who cannot join
- Choledocholithiasis
- <18 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana Numune Education and Research Hospital, Adana, Turkey
Adana
About this study
Official title: 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.
Read the 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.
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- Power Doppler sonography, cholecystitis, adhesion
- Medical subject headings
- Cholecystitis, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Laparoscopic cholecystectomy | |
| 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. Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to ten days
Secondary outcomes (6)
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
Measured: Up to ten days
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
Measured: Up to ten days
Correlation between vascularity and operation time
Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and operation time
Measured: Up to ten days
Correlation between vascularity and drain usage
Correlation between gallbladder wall vascularity (as measured by quantative measurement scale of gallbladder wall vascularity) and drain usage
Measured: Up to ten days
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
Measured: Up to twenty days
Correlation between wall thickness and specimen
Correlation between gallbladder wall thickness and pathologic assessment of specimen
Measured: Up to twenty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startJan 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Cholecystitis With Chronic CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Recep Aktimur, Samsun Education and Research Hospital
- Investigators
- Recep Aktimur, Study director, Samsun Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156947
- Sponsor's protocol ID
- Doppler-Acute Cholecystitis
- Other IDs
- Doppler-Acute cholecystitis
- Status last verified
- Jun 2014
- First submitted
- 1 Jun 2014
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 3890007Uggowitzer 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.
PubMed 9057520Akoglu 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.
PubMed 21796556Cetinkunar 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.
PubMed 25779713
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Preoperative Power Doppler Sonography and Intraoperative Findings - Postoperative Outcomes of Chronic and Acute Cholecystitis Patients: Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT02156947
- Acronym / sponsor ID
- Doppler-Acute Cholecystitis
- Keywords
- Power Doppler sonography, cholecystitis, adhesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Samsun Education and Research HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic cholecystitis | – | Procedure: Laparoscopic cholecystectomyLaparoscopic 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. |
| Acute cholecystitis | – | Procedure: Laparoscopic cholecystectomyLaparoscopic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 80 cholecystitis patients (40 symptomatic chronic, 40 acute).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Choledocholithiasis
- <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomyThe 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). | Procedure or surgery | Acute cholecystitis, Chronic cholecystitis |
Primary outcome
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.
6 secondary outcomes
Correlation between vascularity and gallbladder perforation
Time frame: Up to ten days
Correlation between vascularity and convertion
Time frame: Up to ten days
Correlation between vascularity and operation time
Time frame: Up to ten days
Correlation between vascularity and drain usage
Time frame: Up to ten days
Correlation between vascularity and specimen
Time frame: Up to twenty days
Correlation between wall thickness and specimen
Time frame: Up to twenty days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
- Background: PubMed 3890007Ralls 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.
- Background: PubMed 9057520Uggowitzer 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.
- Background: PubMed 21796556Akoglu 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.
- Derived from this study: PubMed 25779713Cetinkunar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Recep Aktimur study director
Samsun Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis With Chronic Cholecystitis, run by Samsun Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between wall thickness-vascularity and adhesion grade (time frame: Up to ten days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156947, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014.