GallstonesProCholNCT07245108
The Pro-Chol Study
An observational study of Gallstones and Gallstone Attack, run by Nordsjaellands Hospital at 7 sites in Denmark.
Trial summary
This prospective clinical cohort study will include patients with gallstones and abdominal pain scheduled for surgery (laparoscopic cholecystectomy). Data on quality of life, abdominal pain, gallstone disease, and patient characteristics will be collected before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstones, Gallstone Attack, Uncomplicated Cholelithiasis
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 7 sitesDenmark
- Study dates
- 22 Jan 2024to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The population will include patients referred to outpatient clinics either from primary care general practitioners or from a hospital department. Currently six hospitals are included from four out of five Danish health care regions.
Who may be able to join
- Ultrasound examination with presence of gallstones and description of size, number and presence of stones in infundibulum or cystic duct
- Abdominal symptoms believed to be caused by symptomatic uncomplicated gallstones
- Indication and candidate for elective laparoscopic cholecystectomy
- Above 18 years of age
- Ability to give oral and written consent
- Ability to understand, speak and read Danish
- Ability to receive digital post
Who cannot join
- History of complicated gallstone disease including acute cholecystitis, pancreatitis, common bile duct stones, or cholangitis
- Previous sphincterotomy
- Abnormal liver function test (ALAT/ASAT, alkaline phosphatase, bilirubin) without magnetic resonance cholangio-pancreatography or endoscopic ultrasound to rule out common bile duct pathology
- Indication for urgent cholecystectomy
- Current pregnancy
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Daniel Mønsted Shabanzadeh, DMSc, PhD, MD contact
Felix Alfred Graabæk, MD contact
7 sites in 1 country
Denmark7 sites, 7 recruiting
- Recruiting
Aalborg Universitetshospital
Aalborg, 9000
Anders Christian Larsen, PhD, MD, +45 97661100, anchl@rn.dk
- Recruiting
Bispebjerg Hospital
Copenhagen, Bispebjerg, 2400
Anders Kirkegaard-Klitbo, MD, +45 38635264, anders.kirkegaard-klitbo@regionh.dk
- Recruiting
Herlev Hospital
Herlev, 2730
Josephine Viereck Rothman, PhD, MD, +45 38688772, josephine.viereck.rothman@regionh.dk
- Recruiting
Nordsjællands Hospital Hillerød
Hillerød, 3400
Daniel Mønsted Shabanzadeh, DMSc, PhD, MD, +45 48295796, daniel.moensted.shabanzadeh.01@regionh.dk
- Recruiting
Regionshospital Nordjylland Hjørring
Hjørring, 9800
Jane Hansen Kjærgaard, MD, +45 97642690, j.kjaergaard@rn.dk
- Recruiting
Hvidovre Hospital
Hvidovre, 2650
Louise Breum Rasmussen, PhD, MD, +45 38620245, louise.breum.oelgaard.rasmussen@regionh.dk
- Recruiting
Regionshospital Viborg
Viborg, 8800
Tobias Andersen Stadil, MD, +45 78446390, tobistad@rm.dk
About this study
Official title: The ProChol Study - Prospective Assessment of Symptoms Following Cholecystectomy in Patients With Symptomatic Uncomplicated Gallstones
This prospective clinical cohort study will include patients with gallstones and abdominal pain scheduled for surgery (laparoscopic cholecystectomy). Data on quality of life, abdominal pain, gallstone disease, and patient characteristics will be collected before surgery. The outcomes will be assessed three months following surgery and will primarily be determinants for resolution of pain. The aim is to make a prediction score that may aid clinicians and patients in decision making about surgery.
Read the detailed description
Cholecystectomy is the surgical removal of the gallbladder and the only definitive treatment for both symptomatic complicated and uncomplicated gallstones. Surgery rates for laparoscopic cholecystectomy have been rapidly rising in European countries the past decades. Over 9000 cholecystectomies were performed in Denmark in 2016. Symptomatic outcomes following surgery have not been with the intended resolution of symptoms and remaining symptoms are reported in about 35% of patients. This indicates clinical challenges in selecting the patients that will benefit the most from surgery.
The quality of symptomatic outcomes following laparoscopic cholecystectomy should be assessed in a Danish population reflecting current clinical practice for selection of patients with symptomatic uncomplicated gallstones for surgery. Development of a clinical prediction tool for pain relief including both patient-reported and readily available objective variables could aid future patient selection and minimize overall health-care costs and unnecessary surgery risk in patients with symptomatic uncomplicated gallstones.
The aim is to perform a prospective assessment of the symptomatic outcomes of elective laparoscopic intended cholecystectomy in patients with symptomatic uncomplicated gallstones and to develop a prediction model for a pain-free state.
This is a prospective observational study that will be performed across the general surgical hospitals in healthcare regions of Denmark. Consecutive consenting patients will be included from each site until required sample size has reached.
Eligible patients will be identified through screening lists of outpatient clinics and of operating theaters. Patients will be approached for consent and data collection at either the outpatient clinical visit where cholecystectomy is scheduled or at a later timepoint before surgery. Follow-up for symptomatic outcome will be performed three months after surgery. Data collection at both study entry and follow-up will include access to the electronic patient record and answering an online patient questionnaire. If patient questionnaires remain unanswered after one week, the patient will be reminded through an online re-invitation. Data collection at entry will also include the patients' medical history and clinicopathological variables. Data will be stored in a purpose-build database in the clinical research platform REDCap.
The study will be run by a steering committee including senior surgeons acting as local investigators from each of the participating centers. The local investigator will ensure completion of data forms and follow-up procedures. An additional collaborator from each center may further be appointed responsible for patient identification and data collection.
This study is purely observational and no alterations to standard patient treatment will be performed.
A prediction model with high internal and external validity requires model development and validation to be performed in two independent sets of data. To ensure this, half of patients will be included for model development and the other half for model validation.
Based on a previous report, 60% (57%) will become pain-free following cholecystectomy. With a prediction model containing up to 12 exposure variables and a parameter to outcome event ratio of 1:20, the required sample size is 400 patients for model development. The total sample size will be 800 patients for both development and validation of the model. It is estimated that each center will identify about 20 eligible patients each month and the required inclusion period is therefore about two to three years. Sample size may be reduced if prediction model includes fewer variables.
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- Cohort study, Prospective clinical study, Cholecystectomy, Laparoscopic cholecystectomy, Pain relief
- Medical subject headings
- Gallstones, Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
A surgical removal of the gallbladder through laparoscopy
Laparoscopic cholecystectomyProcedure or surgery
The intervention is intended laparoscopic cholecystectomy. Patients that undergo conversion to open (traditional) cholecystectomy will still be included. Patients scheduled for open cholecystectomy will not be included.
| Study group | Role | What they receive |
|---|---|---|
| Patients with gallbladder stones and biliary pain that undergo laparoscopic cholecystectomy | Patients are included if they have gallbladder stones on abdominal ultrasound examination, abdominal pain expected to be due to gallstones by the clinician and scheduled for elective laparoscopic cholecystectomy. Patients with either a history including biliary interventions or complicated gallstone disease such as pancreatitis, cholecystitis or bile duct stones will be excluded. Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction model for resolution of pain
To build and validate a prediction model for resolution of pain (VAS≤4) following laparoscopic cholecystectomy
Measured: From baseline before surgery to follow-up at three months after surgery
Secondary outcomes (1)
Changes in symptoms following surgery
To explore the changes in symptoms following cholecystectomy as defined through 1. core symptoms of the GIQLI questionnaire (such as dyspeptic symptoms, diarrhea, and constipation); 2. GIQLI quality of life total scores.
Measured: From baseline before surgery to follow-up at three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start22 Jan 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
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 GallstonesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Copenhagen University Hospital at Herlev, Aalborg University Hospital, Viborg Regional Hospital, Zealand University Hospital, University Hospital Bispebjerg and Frederiksberg, Regionshospital Nordjylland, Regionshospitalet Viborg, Skive
- Responsible party
- Sponsor
- Investigators
- Daniel Mønsted Shabanzadeh, DMSc, PhD, MD, Principal investigator, Dansk: Offentligt hospital (inkl. universitetshospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245108
- Sponsor's protocol ID
- P-2023-188
- Acronym
- ProChol
- Status last verified
- Oct 2025
- First submitted
- 15 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Latenstein CSS, Hannink G, van der Bilt JDW, Donkervoort SC, Eijsbouts QAJ, Heisterkamp J, Nieuwenhuijs VB, Schreinemakers JMJ, Wiering B, Boermeester MA, Drenth JPH, van Laarhoven CJHM, Dijkgraaf MGW, de Reuver PR; SECURE trial collaborators. A Clinical Decision Tool for Selection of Patients With Symptomatic Cholelithiasis for Cholecystectomy Based on Reduction of Pain and a Pain-Free State Following Surgery. JAMA Surg. 2021 Oct 1;156(10):e213706. doi: 10.1001/jamasurg.2021.3706. Epub 2021 Oct 13.
PubMed 34379080Lamberts MP, Lugtenberg M, Rovers MM, Roukema AJ, Drenth JP, Westert GP, van Laarhoven CJ. Persistent and de novo symptoms after cholecystectomy: a systematic review of cholecystectomy effectiveness. Surg Endosc. 2013 Mar;27(3):709-18. doi: 10.1007/s00464-012-2516-9. Epub 2012 Oct 6.
PubMed 23052498Bray F, Balcaen T, Baro E, Gandon A, Ficheur G, Chazard E. Increased incidence of cholecystectomy related to gallbladder disease in France: Analysis of 807,307 cholecystectomy procedures over a period of seven years. J Visc Surg. 2019 Jun;156(3):209-215. doi: 10.1016/j.jviscsurg.2018.12.003. Epub 2018 Dec 18.
PubMed 30573436Lunevicius R, Nzenwa IC, Mesri M. A nationwide analysis of gallbladder surgery in England between 2000 and 2019. Surgery. 2022 Feb;171(2):276-284. doi: 10.1016/j.surg.2021.10.025. Epub 2021 Nov 12.
PubMed 34782153
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ProChol Study - Prospective Assessment of Symptoms Following Cholecystectomy in Patients With Symptomatic Uncomplicated Gallstones
- ClinicalTrials.gov ID
- NCT07245108
- Acronym / sponsor ID
- ProChol / P-2023-188
- Keywords
- Cohort study, Prospective clinical study, Cholecystectomy, Laparoscopic cholecystectomy, Pain relief
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Copenhagen University Hospital at Herlev, Aalborg University Hospital, Viborg Regional Hospital, Zealand University Hospital, University Hospital Bispebjerg and Frederiksberg, Regionshospital Nordjylland, Regionshospitalet Viborg, Skive
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- 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.
This prospective clinical cohort study will include patients with gallstones and abdominal pain scheduled for surgery (laparoscopic cholecystectomy). Data on quality of life, abdominal pain, gallstone disease, and patient characteristics will be collected before surgery. The outcomes will be assessed three months following surgery and will primarily be determinants for resolution of pain. The aim is to make a prediction score that may aid clinicians and patients in decision making about surgery.
Detailed description
Cholecystectomy is the surgical removal of the gallbladder and the only definitive treatment for both symptomatic complicated and uncomplicated gallstones. Surgery rates for laparoscopic cholecystectomy have been rapidly rising in European countries the past decades. Over 9000 cholecystectomies were performed in Denmark in 2016. Symptomatic outcomes following surgery have not been with the intended resolution of symptoms and remaining symptoms are reported in about 35% of patients. This indicates clinical challenges in selecting the patients that will benefit the most from surgery.
The quality of symptomatic outcomes following laparoscopic cholecystectomy should be assessed in a Danish population reflecting current clinical practice for selection of patients with symptomatic uncomplicated gallstones for surgery. Development of a clinical prediction tool for pain relief including both patient-reported and readily available objective variables could aid future patient selection and minimize overall health-care costs and unnecessary surgery risk in patients with symptomatic uncomplicated gallstones.
The aim is to perform a prospective assessment of the symptomatic outcomes of elective laparoscopic intended cholecystectomy in patients with symptomatic uncomplicated gallstones and to develop a prediction model for a pain-free state.
This is a prospective observational study that will be performed across the general surgical hospitals in healthcare regions of Denmark. Consecutive consenting patients will be included from each site until required sample size has reached.
Eligible patients will be identified through screening lists of outpatient clinics and of operating theaters. Patients will be approached for consent and data collection at either the outpatient clinical visit where cholecystectomy is scheduled or at a later timepoint before surgery. Follow-up for symptomatic outcome will be performed three months after surgery. Data collection at both study entry and follow-up will include access to the electronic patient record and answering an online patient questionnaire. If patient questionnaires remain unanswered after one week, the patient will be reminded through an online re-invitation. Data collection at entry will also include the patients' medical history and clinicopathological variables. Data will be stored in a purpose-build database in the clinical research platform REDCap.
The study will be run by a steering committee including senior surgeons acting as local investigators from each of the participating centers. The local investigator will ensure completion of data forms and follow-up procedures. An additional collaborator from each center may further be appointed responsible for patient identification and data collection.
This study is purely observational and no alterations to standard patient treatment will be performed.
A prediction model with high internal and external validity requires model development and validation to be performed in two independent sets of data. To ensure this, half of patients will be included for model development and the other half for model validation.
Based on a previous report, 60% (57%) will become pain-free following cholecystectomy. With a prediction model containing up to 12 exposure variables and a parameter to outcome event ratio of 1:20, the required sample size is 400 patients for model development. The total sample size will be 800 patients for both development and validation of the model. It is estimated that each center will identify about 20 eligible patients each month and the required inclusion period is therefore about two to three years. Sample size may be reduced if prediction model includes fewer variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with gallbladder stones and biliary pain that undergo laparoscopic cholecystectomy | – | Procedure: Laparoscopic cholecystectomyPatients are included if they have gallbladder stones on abdominal ultrasound examination, abdominal pain expected to be due to gallstones by the clinician and scheduled for elective laparoscopic cholecystectomy. Patients with either a history including biliary interventions or complicated gallstone disease such as pancreatitis, cholecystitis or bile duct stones will be excluded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will include patients referred to outpatient clinics either from primary care general practitioners or from a hospital department. Currently six hospitals are included from four out of five Danish health care regions.
Key inclusion criteria (7 listed)
- Ultrasound examination with presence of gallstones and description of size, number and presence of stones in infundibulum or cystic duct
- Abdominal symptoms believed to be caused by symptomatic uncomplicated gallstones
- Indication and candidate for elective laparoscopic cholecystectomy
- Above 18 years of age
- Ability to give oral and written consent
Key exclusion criteria (5 listed)
- History of complicated gallstone disease including acute cholecystitis, pancreatitis, common bile duct stones, or cholangitis
- Previous sphincterotomy
- Abnormal liver function test (ALAT/ASAT, alkaline phosphatase, bilirubin) without magnetic resonance cholangio-pancreatography or endoscopic ultrasound to rule out common bile duct pathology
- Indication for urgent cholecystectomy
- Current pregnancy
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 cholecystectomyA surgical removal of the gallbladder through laparoscopy | Procedure or surgery | Patients with gallbladder stones and biliary pain that undergo laparoscopic cholecystectomy |
| Laparoscopic cholecystectomyThe intervention is intended laparoscopic cholecystectomy. Patients that undergo conversion to open (traditional) cholecystectomy will still be included. Patients scheduled for open cholecystectomy will not be included. | Procedure or surgery | Patients with gallbladder stones and biliary pain that undergo laparoscopic cholecystectomy |
Primary outcome
Prediction model for resolution of pain
Time frame: From baseline before surgery to follow-up at three months after surgery
To build and validate a prediction model for resolution of pain (VAS≤4) following laparoscopic cholecystectomy
1 secondary outcome
Changes in symptoms following surgery
Time frame: From baseline before surgery to follow-up at three months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 34379080Latenstein CSS, Hannink G, van der Bilt JDW, Donkervoort SC, Eijsbouts QAJ, Heisterkamp J, Nieuwenhuijs VB, Schreinemakers JMJ, Wiering B, Boermeester MA, Drenth JPH, van Laarhoven CJHM, Dijkgraaf MGW, de Reuver PR; SECURE trial collaborators. A Clinical Decision Tool for Selection of Patients With Symptomatic Cholelithiasis for Cholecystectomy Based on Reduction of Pain and a Pain-Free State Following Surgery. JAMA Surg. 2021 Oct 1;156(10):e213706. doi: 10.1001/jamasurg.2021.3706. Epub 2021 Oct 13.
- Background: PubMed 23052498Lamberts MP, Lugtenberg M, Rovers MM, Roukema AJ, Drenth JP, Westert GP, van Laarhoven CJ. Persistent and de novo symptoms after cholecystectomy: a systematic review of cholecystectomy effectiveness. Surg Endosc. 2013 Mar;27(3):709-18. doi: 10.1007/s00464-012-2516-9. Epub 2012 Oct 6.
- Background: PubMed 30573436Bray F, Balcaen T, Baro E, Gandon A, Ficheur G, Chazard E. Increased incidence of cholecystectomy related to gallbladder disease in France: Analysis of 807,307 cholecystectomy procedures over a period of seven years. J Visc Surg. 2019 Jun;156(3):209-215. doi: 10.1016/j.jviscsurg.2018.12.003. Epub 2018 Dec 18.
- Background: PubMed 34782153Lunevicius R, Nzenwa IC, Mesri M. A nationwide analysis of gallbladder surgery in England between 2000 and 2019. Surgery. 2022 Feb;171(2):276-284. doi: 10.1016/j.surg.2021.10.025. Epub 2021 Nov 12.
- Individual participant dataSharing planned: No
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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.
Daniel Mønsted Shabanzadeh, DMSc, PhD, MD contact
Felix Alfred Graabæk, MD contact
Daniel Mønsted Shabanzadeh, DMSc, PhD, MD principal investigator
Dansk: Offentligt hospital (inkl. universitetshospital)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstones and Gallstone Attack, run by Nordsjaellands Hospital at 7 sites in Denmark.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Mønsted Shabanzadeh, DMSc, PhD, MD (+45 48295796, daniel.moensted.shabanzadeh.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction model for resolution of pain (time frame: From baseline before surgery to follow-up at three months after surgery). 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 NCT07245108, 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 24 Nov 2025.