A clinical study on the direction of bile flow in patients with non-jaundice common bile duct stones
| ISRCTN | ISRCTN32172976 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32172976 |
| Secondary identifying numbers | YSPTZX202005 |
- Submission date
- 08/08/2023
- Registration date
- 10/08/2023
- Last edited
- 19/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Even though it's common for certain gallstone problems not to cause jaundice (yellowing of the skin), we don't fully understand why. People often think it's because the bile duct isn't completely blocked. This seems reasonable, but it doesn't explain everything.
This study looked at how bile (a digestive fluid) moves in these cases, using special scans called magnetic resonance cholangiopancreatography and selective intraoperative cholangiography before and during surgery to figure this out.
This study will give us a better overall view of how bile flows, helping us understand why jaundice might not happen in gallstone cases. It also helps doctors decide on the best treatment.
Who can participate?
Patients with anicteric choledocholithiasis admitted to the Department of Hepatobiliary Surgery of Hainan General Hospital from January 2019 to July 2023.
What does the study involve?
Preoperative magnetic resonance cholangiopancreatography and intraoperative cholangiography were performed to determine the direction of bile flow in all patients.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Hainan General Hospital (China)
When is the study starting and how long is it expected to run for?
June 2019 to July 2023
Who is funding the study?
Hainan Provincial Department of Science and Technology (China)
Who is the main contact?
Professor Yunfu Lv, yunfu_lv@126.com
Contact information
Principal Investigator
No.19 Xiuhua Road
Xiuying district
Haikou
570311
China
 ORCID ID |
0000-0003-0451-399X |
|---|---|
| Phone | +86 13687598368 |
| Yunfu_lv@126.com |
Scientific
No.19 Xiuhua Road
Xiuying district
Haikou
570311
China
| Phone | +86 13687598368 |
|---|---|
| Yunfu_lv@126.com |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Treatment |
| Participant information sheet | No participant information sheet available (retrospective study) |
| Scientific title | Classification and treatment of anicteric choledocholithiasis based on the patterns of bile flow into the duodenum |
| Study objectives | The absence of jaundice in these patients may be due to the passage of bile into the duodenum through a specific path. |
| Ethics approval(s) |
Approved 20/12/2018, The medical ethics committee of Hainan general hospital (No.19 Xiuhua road, Xiuying district, Haikou, 570311, China; +86 898-68622476; meng@hnsrmyy14.wecom.work), ref: Med-Eth-Re[2018] 81 |
| Health condition(s) or problem(s) studied | Choledocholithiasis |
| Intervention | Current interventions as of 19/01/2024: Patients with anicteric choledocholithiasis were admitted to the Department of Hepatobiliary Surgery of Hainan General Hospital from January 2019 to July 2023. Preoperative magnetic resonance cholangiopancreatography (MRCP) and intraoperative cholangiography (IOC) were performed to determine the direction of bile flow in all patients. _____ Previous interventions: Patients with anicteric choledocholithiasis were admitted to the Department of Hepatobiliary Surgery of Hainan General Hospital from January 2019 to December 2022. Preoperative magnetic resonance cholangiopancreatography (MRCP) and intraoperative cholangiography (IOC) were performed to determine the direction of bile flow in all patients. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Direction of bile flow measured using MRCP detection and intraoperative cholangiography pre operation. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 20/12/2018 |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 86 Years |
| Sex | Both |
| Target number of participants | 130 |
| Total final enrolment | 103 |
| Key inclusion criteria | 1. Patients with choledocholithiasis and bile duct dilatation (diameter ≥ 8 mm) 2. No jaundice to the naked eye and total serum bilirubin ≤ 34 μmol/L 3. Informed consent |
| Key exclusion criteria | 1. Patients without choledocholithiasis or bile duct dilatation 2. Jaundice visible to the naked eye or serum total bilirubin > 34 μmol/L 3. Congenital choledochal cyst, bile duct tumor, ampullary tumor, and pancreatic head cyst and tumor |
| Date of first enrolment | 03/01/2019 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Xiuying district
Haikou
570311
China
Sponsor information
Hospital/treatment centre
No.19 Xiuhua Road
Xiuying district
Haikou
570311
China
| Phone | +86 898-68622476 |
|---|---|
| kjc@hainmc.edu.cn | |
| Website | http://www.phhp.com.cn/ |
"ROR" |
https://ror.org/030sr2v21 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- 海南省科学技术厅, Department of Science and Technology of Hainan Province
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datesets generated and/or analysed during the current study will be available upon request from Professor Yunfu Lv. Yunfu_lv@126.com |
Editorial Notes
19/01/2024: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2022 to 31/07/2023.
2. The interventions were changed.
3. The recruitment start date was changed from 01/01/2019 to 03/01/2019.
4. The intention to publish date was changed from 31/12/2023 to 31/12/2024.
5. The plain English summary was updated to reflect these changes.
11/01/2024: The following changes were made:
1. The public title was changed from "A clinical study on the direction of bile flow in patients with gallstones" to "A clinical study on the direction of bile flow in patients with non-jaundice common bile duct stones".
2. The scientific title was changed from "Research on bile flow direction and treatment in patients with anicteric choledocholithiasis" to "Classification and treatment of anicteric choledocholithiasis based on the patterns of bile flow into the duodenum"
09/08/2023: Trial's existence confirmed by Hainan General Hospital Medical Ethics Committee.
