Prognostic Factors for Survival in Patients With Cholangiocarcinoma

NCT06369480 | Recruiting

• 1 other identifier: Journal-nr.: R-23057752
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this retrospective study is to determine the survival rates of CCA patients based on different therapeutic approaches. Additionally, we aim to investigate the risk factors associated with poor survival within a cohort of patients treated over a seven-year period across four Danish hospitals. We anticipate that our findings could provide additional evidence for clinical decision-making, improve patient outcomes, and contribute to the knowledge in the field.

Conditions

Cholangiocarcinoma

Keywords

Cholangiocarcinoma; Survival; Surgery; Treatment

Outcome Measures

Primary Outcomes (2)

• Aim I

  Determine the survival rates of CCA patients based on various therapeutic approaches following the MDT decision.

  6 months

• Aim II

  Determine the risk factors associated with unfavorable overall survival in CCA patients.

  6 months

Study Arms (1)

Cholangiocarcinoma

Patients with diagnosis of Cholangiocarcinoma confirmed by MDT

Procedure: Resection/Ablation of tumor; Procedure: Palliative chemotherapy; Procedure: Neoadjuvant chemotherapy; Procedure: Stereotatic radiotherapy; Procedure: Best supportive care

Interventions

Resection/Ablation of tumor PROCEDURE

Curative treatment

Also known as: Surgery

Cholangiocarcinoma

Palliative chemotherapy PROCEDURE

Chemotherapeutic medications

Also known as: Chemotherapy

Cholangiocarcinoma

Neoadjuvant chemotherapy PROCEDURE

Chemotherapeutic medications after surgery

Also known as: Adjuvant chemotherapy

Cholangiocarcinoma

Stereotatic radiotherapy PROCEDURE

Radiotherapy

Also known as: Radiotherapy

Cholangiocarcinoma

Best supportive care PROCEDURE

Symptomatic treatment, non-curative treatment

Also known as: Supportive care

Cholangiocarcinoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients identified in the Danish Liver-Biliary Cancer Database with a confirmed diagnosis of cholangiocarcinoma registered from 2013 to 2020.

You may qualify if:

• Patients' eligibility for this study is contingent on a diagnosis of CCA confirmed by the MDT from Aalborg Universitetshospital, Aarhus Universitetshospital, Odense Universitetshospital, and Rigshospitalet in Denmark from 2013 to 2020.

You may not qualify if:

• We will exclude from the analysis all records with more than one interventions. Additionally, all patients whose cholangiocarcinoma diagnosis was canceled following the MDT meeting will be also excluded, as well those with inconsistent data regarding date of reference to the MDT.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (6)

• Tawarungruang C, Khuntikeo N, Chamadol N, Laopaiboon V, Thuanman J, Thinkhamrop K, Kelly M, Thinkhamrop B. Survival after surgery among patients with cholangiocarcinoma in Northeast Thailand according to anatomical and morphological classification. BMC Cancer. 2021 May 3;21(1):497. doi: 10.1186/s12885-021-08247-z.

  PMID: 33941120 BACKGROUND

• Thuehoj AU, Andersen NC, Worm ES, Hoyer M, Tabaksblat EM, Weber B, Mortensen HR. Clinical outcomes after stereotactic ablative radiotherapy in locally advanced cholangiocarcinoma. Acta Oncol. 2022 Feb;61(2):197-201. doi: 10.1080/0284186X.2021.1995893. Epub 2021 Nov 2. No abstract available.

  PMID: 34726565 BACKGROUND

• Cillo U, Fondevila C, Donadon M, Gringeri E, Mocchegiani F, Schlitt HJ, Ijzermans JNM, Vivarelli M, Zieniewicz K, Olde Damink SWM, Groot Koerkamp B. Surgery for cholangiocarcinoma. Liver Int. 2019 May;39 Suppl 1(Suppl Suppl 1):143-155. doi: 10.1111/liv.14089.

  PMID: 30843343 BACKGROUND

• Moris D, Palta M, Kim C, Allen PJ, Morse MA, Lidsky ME. Advances in the treatment of intrahepatic cholangiocarcinoma: An overview of the current and future therapeutic landscape for clinicians. CA Cancer J Clin. 2023 Mar;73(2):198-222. doi: 10.3322/caac.21759. Epub 2022 Oct 19.

  PMID: 36260350 BACKGROUND

• Li Y, Song Y, Liu S. The new insight of treatment in Cholangiocarcinoma. J Cancer. 2022 Jan 1;13(2):450-464. doi: 10.7150/jca.68264. eCollection 2022.

  PMID: 35069894 BACKGROUND

• Ma KW, Cheung TT, Leung B, She BWH, Chok KSH, Chan ACY, Dai WC, Lo CM. Adjuvant chemotherapy improves oncological outcomes of resectable intrahepatic cholangiocarcinoma: A meta-analysis. Medicine (Baltimore). 2019 Feb;98(5):e14013. doi: 10.1097/MD.0000000000014013.

  PMID: 30702559 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Surgical Procedures, Operative; Drug Therapy; Neoadjuvant Therapy; Chemotherapy, Adjuvant; Radiotherapy; Palliative Care

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Combined Modality Therapy; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Hans-Christian Pommergaard, M.D./Ph.D.

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans-Christian Pommergaard, M.D./Ph.D

CONTACT

35458519; hans-christian.pommergaard@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Specialist, Department of Surgery and Transplantation, Hepato - Pancreato - Biliary (HPB) team, Rigshospitalet, University of Copenhagen

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start: February 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)