Nomogram for Predicting Biliary Complication

NCT06658665 | Not Yet Recruiting

• 1 other identifier: FAH-SYSU
• Study Type: observational
• Target: 900
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to develop a nomogram model to predict biliary complications within 90 days in adult patients after liver transplantation. The main questions it aims to answer are: Can the nomogram predict biliary complications within 90 days in adult patients after liver transplantation? What about the performance of the nomogram? Researchers will compare patients' preoperative variables, intraoperative factors, and postoperative outcomes to see what factors are associated with biliary complications.Subsequently, multivariable logistic regression analysis was conducted to evaluate the factors associated with biliary complications occurring within 90 days post-liver transplantation. Finally, a nomogram was developed.

Conditions

Liver Transplant Disorder

Keywords

liver transplantation; biliary complication; nomogram; prediction model

Outcome Measures

Primary Outcomes (7)

• Body Mass Index (BMI):

  Calculated as weight (kg) / height (m²).

  1-2 days before surgery

• Surgical Technique

  Type of technique used (orthotopic, piggyback, or ischemia-free liver transplantation).

  Intraoperative time

• Weight

  Measured in kilograms.

  1-2 days before surgery

• Height

  Measured in meters.

  1-2 days before surgery

• Blood Loss

  Measured in milliliters (mL).

  1-2 days before surgery

• Cold Ischemic Time

  Measured in minutes.

  intraoperative time

• Warm Ischemic Time

  Measured in minutes.

  intraoperative time

Secondary Outcomes (2)

• Transaminase Levels

  24 hours post-surgery.

• ICU Stay Duration

  24 hours post-surgery

Study Arms (2)

No biliary complication group

The liver transplant patients who did not experience biliary complications within 90 days post-operation.

biliary complication group

The liver transplant patients who experience biliary complications within 90 days post-operation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective collection of cases of patients who underwent liver transplantation in the Organ Transplantation Department at Sun Yat-sen University First Affiliated Hospital between January 1, 2016, and December 31, 2021.

You may qualify if:

• ①Patients aged ≥ 18 years.
• ②Patients who underwent their first liver transplantation at Sun Yat-sen University First Affiliated Hospital between January 1, 2016, and December 31, 2021.

You may not qualify if:

• Living donor liver transplantation. ② Split liver transplantation.
• Multi-organ transplantation. ④ Missing preoperative baseline indicators and postoperative ultrasound examination results.
• Patients undergoing re-transplantation.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Related Publications (6)

• Tingle SJ, Thompson ER, Ali SS, Figueiredo R, Hudson M, Sen G, White SA, Manas DM, Wilson CH. Risk factors and impact of early anastomotic biliary complications after liver transplantation: UK registry analysis. BJS Open. 2021 Mar 5;5(2):zrab019. doi: 10.1093/bjsopen/zrab019.

  PMID: 33855363 BACKGROUND

• Feng LH, Sun HC, Zhu XD, Liu XF, Zhang SZ, Li XL, Li Y, Tang ZY. Prognostic nomograms and risk classifications of outcomes in very early-stage hepatocellular carcinoma patients after hepatectomy. Eur J Surg Oncol. 2021 Mar;47(3 Pt B):681-689. doi: 10.1016/j.ejso.2020.10.039. Epub 2020 Oct 31.

  PMID: 33189491 BACKGROUND

• Ahmad T, Chavhan GB, Avitzur Y, Moineddin R, Oudjhane K. Doppler Parameters of the Hepatic Artery as Predictors of Graft Status in Pediatric Liver Transplantation. AJR Am J Roentgenol. 2017 Sep;209(3):671-675. doi: 10.2214/AJR.17.17902. Epub 2017 Jun 28.

  PMID: 28657844 BACKGROUND

• Asthana S, McClean P, Stringer MD. Does the pediatric end-stage liver disease score or hepatic artery resistance index predict outcome after liver transplantation for biliary atresia? Pediatr Surg Int. 2006 Sep;22(9):697-700. doi: 10.1007/s00383-006-1737-1. Epub 2006 Aug 1.

  PMID: 16896815 BACKGROUND

• Perrakis A, Fortsch T, Niebling N, Croner RS, Nissler V, Yedibela S, Lohmuller C, Zopf S, Kammerer F, Hohenberger W, Muller V. The diagnostic value of systolic acceleration time and resistive index as noninvasive modality for detection of graft rejection after orthotopic liver transplantation. Transplant Proc. 2013 Jun;45(5):1961-5. doi: 10.1016/j.transproceed.2013.01.058.

  PMID: 23769083 BACKGROUND

• Magro B, Tacelli M, Mazzola A, Conti F, Celsa C. Biliary complications after liver transplantation: current perspectives and future strategies. Hepatobiliary Surg Nutr. 2021 Jan;10(1):76-92. doi: 10.21037/hbsn.2019.09.01.

  PMID: 33575291 BACKGROUND

Central Study Contacts

Zepeng Lin

CONTACT

+86 13421560359; 13421560359@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: November 1, 2024
• Primary Completion: November 15, 2024
• Study Completion: December 30, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP