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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Nepal1 site
  • Tokha Road, Dhapasi

    Kathmandu, Bagmati, 44600

Other trials in Nepal

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.

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.

  1. 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.

  1. First posted27 Jan 2025
  2. Study start1 Jan 2022
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

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)
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 27298653
  • 3. 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

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.

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