Liver DysfunctionIHBRNCT06793007
Variants Of Intrahepatic Biliary Radicals in Nepali Population
An observational study of Liver Dysfunction, run by Grande International Hospital, Nepal at 1 site in Nepal.
Trial summary
Biliary anatomical variations are commonly observed during diagnostic imaging and, if overlooked, can lead to considerable risks during surgical, endoscopic, or other interventional procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Dysfunction
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 384 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2022to 30 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of all gender and age 18 and above
Who may be able to join
- All high quality, diagnostically adequate MRCP scans of patients age > 18 years done in our department for various indications an no previous hepatobiliary surgery (except cholecystectomy)are included in the study
Who cannot join
- Diagnostically inadequate, unclear MRCP scans were excluded from the study. Also, scans of patient < 18 years, patients with hepatobiliary surgery and pathology distorting normal anatomy were also excluded. Scans with biliary obstruction were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anatomical Variants of Intrahepatic Bile Ducts and Cystic Duct in Magnetic Resonance Cholangiopancreatography: A Retrospective Cross-Sectional Study in a Tertiary Hospital in Kathmandu.
Biliary anatomical variations are commonly observed during diagnostic imaging and, if overlooked, can lead to considerable risks during surgical, endoscopic, or other interventional procedures. In Nepal, where advanced imaging techniques such as MRCP are becoming more accessible, it is crucial to understand the prevalence and types of these variants within the local population. This understanding aids in enhancing pre-surgical planning, minimizing surgical complications, and improving diagnostic precision. By analyzing retrospective data from a private hospital, this study aims to provide important insights into regional anatomical variations, supporting improved clinical outcomes.
Read the detailed description
Anatomy of the biliary tree is intricate, with numerous intrahepatic and extrahepatic variations and cystic duct variations that are crucial to recognize to avoid complications in surgical or interventional procedures (1,2). Detailed anatomical knowledge is essential as bile duct surgeries, liver resections, and transplants become increasingly sophisticated (1). Magnetic Resonance Cholangiopancreatography (MRCP) is a preferred non-invasive imaging technique that safely and accurately maps both the bile and cystic duct anatomy without radiation exposure, ideal for patients with contrast allergies (2). Intrahepatic bile ducts follow the portal veins, with the right hepatic duct draining segments 5, 6, 7, and 8 and the left hepatic duct draining segments 2, 3, and 4. The right and left hepatic ducts merge at the hilum to form the CHD. With standard branching patterns occurring in roughly 50-60% of cases, knowledge of these frequent variants is critical for safe and effective surgical planning (4).
The classification of the right hepatic duct (RHD) by Huang et al. (2) includes five types: Type A1 (classic, RPD and RAD form RHD), Type A2 (trifurcation, all ducts converge), Type A3 (RPD drains into LHD), Type A4 (RAD drains into CHD), and Type A5 (absent RHD). Karakas et al. similarly classify the RHD into five types, mirroring Huang's types with slight variations in naming conventions. The left hepatic duct (LHD) classification by Cho A et al. (2) consists of four types: Type I (classic, LHD drains into RHD), Type II (accessory duct from the left lateral segment), Type III (segmental ducts join RHD or CHD separately), and Type IV (no unified LHD formation). These classifications are essential for understanding anatomical variations relevant to hepatobiliary surgeries and MRCP imaging.
Typically, the cystic duct is 2-4 cm long and 1-5 mm in diameter, joining the gallbladder neck to the common hepatic duct (CHD) to form the common bile duct (CBD), usually entering the CHD from the right lateral side (4). Variations in the cystic duct's insertion, length, and course-including low or high insertion points, parallel courses with the CHD, spiral orientations, and occasionally absent ducts-are documented and clinically significant (4).
There are few studies of similar kind done in Nepali population. Sharma et al(1)studied the prevalences of different variants of right hepatic duct as per classification of choi et al in 90 patients. In their study, 47.8% of patients were classified as having Type 1/normal intrahepatic bile duct (IHBD) variations (n=43). Type 2 was observed in 20% of the cases (n=18), while Type 3A accounted for 3.3% (n=3) and Type 3B for 5.6%. Type 5A was present in 5 patients (n=5), and Type 5B in 7.8% (n=7), with Type 6 seen in 3.3% (n=3) and Type 7 in 6.7% (n=6). No cases of Type 3C or Type 4 variations were identified. Among the Type 1 patients, 67.44% (n=29) were female, while the remainder were male. Sarawagi R(2) et al conducted a study similar to ours and obtained the prevalences of variants of right hepatic duct as per classification by Huang et al. The right posterior sectoral duct (RPSD) draining into the left hepatic duct (LHD) was the most common variant, observed in 27.6% of subjects. A trifurcation pattern was noted in 9.3% of cases, while 4% of subjects had the RPSD draining into the common hepatic duct (CHD) and 0.8% into the cystic duct. Other variants were seen in 2.6% of subjects, and an accessory duct was present in 4.9% of cases. The most frequent branching pattern of the LHD was a common trunk formed by the segment 2 and 3 ducts joining the segment 4 duct, seen in 67.8% of subjects. In 23.2% of subjects, the segment 2 duct united with the common trunk of segments 3 and 4, while 3.4% had all three segments (2, 3, and 4) merging to form the LHD. Other less common branching patterns were observed in 4.9% of subjects.K.C et al(3) studied about variants of cystic duct in Nepali population in 252 patients. The most frequently observed type was the right lateral insertion, found in 120 patients (47.62%), while the remaining patients exhibited other anatomical variants. The posterior insertion was the second most common variant, seen in 36 patients (14.29%), followed by high insertion in 25 patients (9.92%). The right posterior sectoral hepatic duct draining into the cystic duct was the least common variant. Sarawagi et al(4) also studied about variants of cystic duct in MRCP in Indian population. Normal lateral insertion of the cystic duct (CD) at the middle third of the common hepatic duct was found in 51% of cases. Medial insertion was seen in 16% (4% low medial), while low insertion occurred in 9%. A parallel course of the CD was present in 7.5%, high insertion in 6%, and a short CD in 1%. In one case, the CD drained into the right hepatic duct, and another case exhibited congenital cystic dilation consistent with a type IV choledochal cyst.
The four studies collectively highlight the diversity and prevalence of anatomical variations in the biliary system across different populations. Variations in the right hepatic duct were common, with normal intrahepatic bile duct patterns (Type 1) being the most prevalent, seen in 47.8% of cases in Sharma et al.'s study, while Sarawagi et al. noted that the right posterior sectoral duct (RPSD) draining into the left hepatic duct was the most frequent variant (27.6%). Trifurcation patterns and accessory ducts were also observed but were less common. Regarding cystic duct variants, both K.C. et al. and Sarawagi et al. found that the lateral insertion into the common hepatic duct was the most prevalent pattern, seen in 47.62% and 51% of cases, respectively. Other common variations included posterior and high insertions of the cystic duct, while rare cases such as RPSD draining into the cystic duct and congenital cystic dilation were also documented. These findings underscore the significance of understanding these variations for clinical and surgical applications.
- Conditions
- Liver Dysfunction
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
Magnetic resonance imaging cholangiopancreatography
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of different variants on intrahepatic biliary radicals
Prevalence of different variants on intrahepatic biliary radicals in Nepali population
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Jan 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
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 Liver DysfunctionStudies 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
- Retrospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grande International Hospital, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PRAJWAL DAHAL, Grande International Hospital, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793007
- Sponsor's protocol ID
- 12/2024
- Acronym
- IHBR
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Paudel S, Joshi BR, Chand RB. Evaluation of Intrahepatic Bile Duct Variations in Magnetic Resonance Cholangiopancreatography. Nepal J Radiol. 2020 Dec 1;10(1):27-33.
Sarawagi R, Sundar S, Raghuvanshi S, Gupta SK, Jayaraman G. Common and Uncommon Anatomical Variants of Intrahepatic Bile Ducts in Magnetic Resonance Cholangiopancreatography and its Clinical Implication. Pol J Radiol. 2016 May 26;81:250-5. doi: 10.12659/PJR.895827. eCollection 2016.
PubMed 272986533. Kc S, Banjade UR, Ghimire P. Anatomical variations of the cystic duct assessed by magnetic resonance cholangiopancreatography (MRCP): a cross-sectional study at tertiary center of Nepal. J Patan Acad Health Sci. 2024 Jun 14;11(1):15-20.
Sarawagi R, Sundar S, Gupta SK, Raghuwanshi S. Anatomical Variations of Cystic Ducts in Magnetic Resonance Cholangiopancreatography and Clinical Implications. Radiol Res Pract. 2016;2016:3021484. doi: 10.1155/2016/3021484. Epub 2016 May 25.
PubMed 27313891
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Variants of Intrahepatic Bile Ducts and Cystic Duct in Magnetic Resonance Cholangiopancreatography: A Retrospective Cross-Sectional Study in a Tertiary Hospital in Kathmandu.
- ClinicalTrials.gov ID
- NCT06793007
- Acronym / sponsor ID
- IHBR / 12/2024
- Conditions
- Liver Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Grande International Hospital, NepalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 27 Jan 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.
Biliary anatomical variations are commonly observed during diagnostic imaging and, if overlooked, can lead to considerable risks during surgical, endoscopic, or other interventional procedures. In Nepal, where advanced imaging techniques such as MRCP are becoming more accessible, it is crucial to understand the prevalence and types of these variants within the local population. This understanding aids in enhancing pre-surgical planning, minimizing surgical complications, and improving diagnostic precision. By analyzing retrospective data from a private hospital, this study aims to provide important insights into regional anatomical variations, supporting improved clinical outcomes.
Detailed description
Anatomy of the biliary tree is intricate, with numerous intrahepatic and extrahepatic variations and cystic duct variations that are crucial to recognize to avoid complications in surgical or interventional procedures (1,2). Detailed anatomical knowledge is essential as bile duct surgeries, liver resections, and transplants become increasingly sophisticated (1). Magnetic Resonance Cholangiopancreatography (MRCP) is a preferred non-invasive imaging technique that safely and accurately maps both the bile and cystic duct anatomy without radiation exposure, ideal for patients with contrast allergies (2). Intrahepatic bile ducts follow the portal veins, with the right hepatic duct draining segments 5, 6, 7, and 8 and the left hepatic duct draining segments 2, 3, and 4. The right and left hepatic ducts merge at the hilum to form the CHD. With standard branching patterns occurring in roughly 50-60% of cases, knowledge of these frequent variants is critical for safe and effective surgical planning (4).
The classification of the right hepatic duct (RHD) by Huang et al. (2) includes five types: Type A1 (classic, RPD and RAD form RHD), Type A2 (trifurcation, all ducts converge), Type A3 (RPD drains into LHD), Type A4 (RAD drains into CHD), and Type A5 (absent RHD). Karakas et al. similarly classify the RHD into five types, mirroring Huang's types with slight variations in naming conventions. The left hepatic duct (LHD) classification by Cho A et al. (2) consists of four types: Type I (classic, LHD drains into RHD), Type II (accessory duct from the left lateral segment), Type III (segmental ducts join RHD or CHD separately), and Type IV (no unified LHD formation). These classifications are essential for understanding anatomical variations relevant to hepatobiliary surgeries and MRCP imaging.
Typically, the cystic duct is 2-4 cm long and 1-5 mm in diameter, joining the gallbladder neck to the common hepatic duct (CHD) to form the common bile duct (CBD), usually entering the CHD from the right lateral side (4). Variations in the cystic duct's insertion, length, and course-including low or high insertion points, parallel courses with the CHD, spiral orientations, and occasionally absent ducts-are documented and clinically significant (4).
There are few studies of similar kind done in Nepali population. Sharma et al(1)studied the prevalences of different variants of right hepatic duct as per classification of choi et al in 90 patients. In their study, 47.8% of patients were classified as having Type 1/normal intrahepatic bile duct (IHBD) variations (n=43). Type 2 was observed in 20% of the cases (n=18), while Type 3A accounted for 3.3% (n=3) and Type 3B for 5.6%. Type 5A was present in 5 patients (n=5), and Type 5B in 7.8% (n=7), with Type 6 seen in 3.3% (n=3) and Type 7 in 6.7% (n=6). No cases of Type 3C or Type 4 variations were identified. Among the Type 1 patients, 67.44% (n=29) were female, while the remainder were male. Sarawagi R(2) et al conducted a study similar to ours and obtained the prevalences of variants of right hepatic duct as per classification by Huang et al. The right posterior sectoral duct (RPSD) draining into the left hepatic duct (LHD) was the most common variant, observed in 27.6% of subjects. A trifurcation pattern was noted in 9.3% of cases, while 4% of subjects had the RPSD draining into the common hepatic duct (CHD) and 0.8% into the cystic duct. Other variants were seen in 2.6% of subjects, and an accessory duct was present in 4.9% of cases. The most frequent branching pattern of the LHD was a common trunk formed by the segment 2 and 3 ducts joining the segment 4 duct, seen in 67.8% of subjects. In 23.2% of subjects, the segment 2 duct united with the common trunk of segments 3 and 4, while 3.4% had all three segments (2, 3, and 4) merging to form the LHD. Other less common branching patterns were observed in 4.9% of subjects.K.C et al(3) studied about variants of cystic duct in Nepali population in 252 patients. The most frequently observed type was the right lateral insertion, found in 120 patients (47.62%), while the remaining patients exhibited other anatomical variants. The posterior insertion was the second most common variant, seen in 36 patients (14.29%), followed by high insertion in 25 patients (9.92%). The right posterior sectoral hepatic duct draining into the cystic duct was the least common variant. Sarawagi et al(4) also studied about variants of cystic duct in MRCP in Indian population. Normal lateral insertion of the cystic duct (CD) at the middle third of the common hepatic duct was found in 51% of cases. Medial insertion was seen in 16% (4% low medial), while low insertion occurred in 9%. A parallel course of the CD was present in 7.5%, high insertion in 6%, and a short CD in 1%. In one case, the CD drained into the right hepatic duct, and another case exhibited congenital cystic dilation consistent with a type IV choledochal cyst.
The four studies collectively highlight the diversity and prevalence of anatomical variations in the biliary system across different populations. Variations in the right hepatic duct were common, with normal intrahepatic bile duct patterns (Type 1) being the most prevalent, seen in 47.8% of cases in Sharma et al.'s study, while Sarawagi et al. noted that the right posterior sectoral duct (RPSD) draining into the left hepatic duct was the most frequent variant (27.6%). Trifurcation patterns and accessory ducts were also observed but were less common. Regarding cystic duct variants, both K.C. et al. and Sarawagi et al. found that the lateral insertion into the common hepatic duct was the most prevalent pattern, seen in 47.62% and 51% of cases, respectively. Other common variations included posterior and high insertions of the cystic duct, while rare cases such as RPSD draining into the cystic duct and congenital cystic dilation were also documented. These findings underscore the significance of understanding these variations for clinical and surgical applications.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of all gender and age 18 and above
Key inclusion criteria (1 listed)
- All high quality, diagnostically adequate MRCP scans of patients age > 18 years done in our department for various indications an no previous hepatobiliary surgery (except cholecystectomy)are included in the study
Key exclusion criteria (1 listed)
- Diagnostically inadequate, unclear MRCP scans were excluded from the study. Also, scans of patient < 18 years, patients with hepatobiliary surgery and pathology distorting normal anatomy were also excluded. Scans with biliary obstruction were also excluded from the study.
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 |
|---|---|---|
| Magnetic Resonance ImagingMagnetic resonance imaging cholangiopancreatography | Diagnostic test | – |
Primary outcome
Prevalence of different variants on intrahepatic biliary radicals
Time frame: 6 months
Prevalence of different variants on intrahepatic biliary radicals in Nepali population
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 27 Jan 2025.
- Background1. Paudel S, Joshi BR, Chand RB. Evaluation of Intrahepatic Bile Duct Variations in Magnetic Resonance Cholangiopancreatography. Nepal J Radiol. 2020 Dec 1;10(1):27-33.
- Background: PubMed 27298653Sarawagi R, Sundar S, Raghuvanshi S, Gupta SK, Jayaraman G. Common and Uncommon Anatomical Variants of Intrahepatic Bile Ducts in Magnetic Resonance Cholangiopancreatography and its Clinical Implication. Pol J Radiol. 2016 May 26;81:250-5. doi: 10.12659/PJR.895827. eCollection 2016.
- Background3. Kc S, Banjade UR, Ghimire P. Anatomical variations of the cystic duct assessed by magnetic resonance cholangiopancreatography (MRCP): a cross-sectional study at tertiary center of Nepal. J Patan Acad Health Sci. 2024 Jun 14;11(1):15-20.
- Background: PubMed 27313891Sarawagi R, Sundar S, Gupta SK, Raghuwanshi S. Anatomical Variations of Cystic Ducts in Magnetic Resonance Cholangiopancreatography and Clinical Implications. Radiol Res Pract. 2016;2016:3021484. doi: 10.1155/2016/3021484. Epub 2016 May 25.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Liver Dysfunction, run by Grande International Hospital, Nepal at 1 site in Nepal.
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 1 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 27 Jan 2025. 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 Nepal. 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?
Prevalence of different variants on intrahepatic biliary radicals (time frame: 6 months). 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 NCT06793007, 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 27 Jan 2025.