CholelithiasisNCT02654873
Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?
An observational study of Cholelithiasis, run by Sisli Hamidiye Etfal Training and Research Hospital at 6 sites in Turkey (Türkiye).
Trial summary
Cholecystectomy has been made with benign conditions usually. The aim of this study is to compare the macroscopic evaluations of the cholecystectomy specimens with it's histopathological examinations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholelithiasis
- How many people
- 1,000 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- Dec 2015to May 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1000 patients who is operated with non inflamated cholelithiasis will be included to this study.
Who may be able to join
- Subject has cholelithiasis
Who cannot join
- Subject has acute cholecystitis
- Subject has perforated gallbladder
- Subject has malignancy
- Subject has polyps in the gallbladder
- Subject has increasing wall thickness of the gallbladder
- Subject has malignancy in the preoperative ultrasonography in the gallbladder
- Subject has pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Turkey (Türkiye)6 sites
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
Erzincan University
Erzincan
Bezmialem Vakif University
Istanbul, 34093
Sisli Etfal Training and Research Hospital
Istanbul, 34371
Arnavutkoy State Hospital
Istanbul
Istanbul Training and Research Hospital
Istanbul
About this study
Cholecystectomy has been made with benign conditions usually. The aim of this study is to compare the macroscopic evaluations of the cholecystectomy specimens with it's histopathological examinations.
Read the detailed description
Cholecystectomy is one of the most frequently performed surgery in the world and often made with benign conditions. Routinely cholecystectomy specimens sent for histopathologic examination. The histopathologic examination of the cholecystectomy specimens are benign in most of the cases and the incidental malignancy of the gallbladder is 2-2.9% in the literature. The histopathologic evaluations of the gallbladder come with additional workload for pathology and surgery departments. Also there is additional cost for the patients. Because of that the idea of selective histopathologic examination has been raised.
- Conditions
- Cholelithiasis
- Keywords
- histopathology, gallbladder, specimen
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benign | Benign pathology specimens with macroscopically | |
| Suspicious | Suspicious group includes the conditions such as increasing of the gallbladder wall thickness, having calcifications or polyps in the gallbladder. | |
| Malign | Malign group includes the conditions such as detecting mass or irregularities in the gallbladder wall. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases
The 1000 cholecystectomy specimens will be evaluated macroscopically by two experienced surgeons with a longitudinal incision to the gallbladder. The specimens will be grouped as benign, suspicious, malign according to the surgeon's decision. To confirm the surgeon's macroscopic evaluation, all of the specimens will be evaluated histopathologically. The results of macroscopic and histopathological examinations will be compared.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionOct 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University, Istanbul Training and Research Hospital, Erzincan University, Arnavutkoy State Hospital, Bursa Yuksek Ihtisas Training and Research Hospital
- Responsible party
- Principal investigator, Ufuk Oguz Idiz, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Ufuk Oguz Idiz, M.D., Study director, Sisli Etfal Training and Research HospitalHuseyin Bektasoglu, M.D., Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654873
- Sponsor's protocol ID
- Sislietfal
- Status last verified
- Feb 2019
- First submitted
- 10 Jan 2016
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Because the time period of this study is very short
Publications
Elshaer M, Gravante G, Yang Y, Hudson S, Thomas K, Sorge R, Al-Hamali S, Kelkar A, Ebdewi H. Routine versus selective histologic analysis of gallbladder specimens for the detection of incidental gallbladder cancers. A retrospective review over 9 years of activity with a special focus on patients' age. Am J Surg. 2014 Sep;208(3):444-9. doi: 10.1016/j.amjsurg.2013.12.038. Epub 2014 Apr 3.
PubMed 24811928Siddiqui FG, Memon AA, Abro AH, Sasoli NA, Ahmad L. Routine histopathology of gallbladder after elective cholecystectomy for gallstones: waste of resources or a justified act? BMC Surg. 2013 Jul 8;13:26. doi: 10.1186/1471-2482-13-26.
PubMed 23834815Deng YL, Xiong XZ, Zhou Y, Shrestha A, Li FY, Cheng NS. Selective histology of cholecystectomy specimens--is it justified? J Surg Res. 2015 Jan;193(1):196-201. doi: 10.1016/j.jss.2014.07.039. Epub 2014 Jul 24.
PubMed 25151466
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?
- ClinicalTrials.gov ID
- NCT02654873
- Acronym / sponsor ID
- Sislietfal
- Conditions
- Cholelithiasis
- Keywords
- histopathology, gallbladder, specimen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University, Istanbul Training and Research Hospital, Erzincan University, Arnavutkoy State Hospital, Bursa Yuksek Ihtisas Training and Research Hospital
- Study start
- Dec 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 13 Jan 2016 (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.
Cholecystectomy has been made with benign conditions usually. The aim of this study is to compare the macroscopic evaluations of the cholecystectomy specimens with it's histopathological examinations.
Detailed description
Cholecystectomy is one of the most frequently performed surgery in the world and often made with benign conditions. Routinely cholecystectomy specimens sent for histopathologic examination. The histopathologic examination of the cholecystectomy specimens are benign in most of the cases and the incidental malignancy of the gallbladder is 2-2.9% in the literature. The histopathologic evaluations of the gallbladder come with additional workload for pathology and surgery departments. Also there is additional cost for the patients. Because of that the idea of selective histopathologic examination has been raised.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Benign | – | –Benign pathology specimens with macroscopically |
| Suspicious | – | –Suspicious group includes the conditions such as increasing of the gallbladder wall thickness, having calcifications or polyps in the gallbladder. |
| Malign | – | –Malign group includes the conditions such as detecting mass or irregularities in the gallbladder wall. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 patients who is operated with non inflamated cholelithiasis will be included to this study.
Key inclusion criteria (1 listed)
- Subject has cholelithiasis
Key exclusion criteria (7 listed)
- Subject has acute cholecystitis
- Subject has perforated gallbladder
- Subject has malignancy
- Subject has polyps in the gallbladder
- Subject has increasing wall thickness of the gallbladder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases
Time frame: 15 days
The 1000 cholecystectomy specimens will be evaluated macroscopically by two experienced surgeons with a longitudinal incision to the gallbladder. The specimens will be grouped as benign, suspicious, malign according to the surgeon's decision. To confirm the surgeon's macroscopic evaluation, all of the specimens will be evaluated histopathologically. The results of macroscopic and histopathological examinations will be compared.
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 19 Feb 2019.
- Background: PubMed 24811928Elshaer M, Gravante G, Yang Y, Hudson S, Thomas K, Sorge R, Al-Hamali S, Kelkar A, Ebdewi H. Routine versus selective histologic analysis of gallbladder specimens for the detection of incidental gallbladder cancers. A retrospective review over 9 years of activity with a special focus on patients' age. Am J Surg. 2014 Sep;208(3):444-9. doi: 10.1016/j.amjsurg.2013.12.038. Epub 2014 Apr 3.
- Background: PubMed 23834815Siddiqui FG, Memon AA, Abro AH, Sasoli NA, Ahmad L. Routine histopathology of gallbladder after elective cholecystectomy for gallstones: waste of resources or a justified act? BMC Surg. 2013 Jul 8;13:26. doi: 10.1186/1471-2482-13-26.
- Results publication: PubMed 25151466Deng YL, Xiong XZ, Zhou Y, Shrestha A, Li FY, Cheng NS. Selective histology of cholecystectomy specimens--is it justified? J Surg Res. 2015 Jan;193(1):196-201. doi: 10.1016/j.jss.2014.07.039. Epub 2014 Jul 24.
- Individual participant dataSharing planned: Undecided. Because the time period of this study is very short
Related trials for Cholelithiasis
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
RecruitingPhase 4
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
Intravenous Anesthesia, Cholelithiasis
Recruiting
Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration
Cholelithiases, Cholecystitis
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.
Ufuk Oguz Idiz, M.D. study director
Sisli Etfal Training and Research Hospital
Huseyin Bektasoglu, M.D. principal investigator
Bezmialem Vakif University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholelithiasis, run by Sisli Hamidiye Etfal Training and Research Hospital at 6 sites 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 1 inclusion and 7 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases (time frame: 15 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 NCT02654873, which also lists 3 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 19 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.