Craniopharyngioma With Tumoral Hemorrhage

June 21, 2021 updated by: Kai Shu, Tongji Hospital

Clinical Features and Risk Factors of Craniopharyngioma With Tumoral Hemorrhage

Clinical data of 185 consecutive patients receiving resective operation with a pathological diagnosis of craniopharyngioma in our hospital between January 2013 and February 2021 were collected. Among these patients, 18 of them were recognized as craniopharyngioma with tumoral hemorrhage during the operation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For each case, age, gender, smoking status, alcohol intake, past history, symptoms, blood pressure, blood cell count, blood biochemical tests, coagulation tests, hormone tests, radiological results, surgical treatment and the outcome at discharge were collected. The first test result after admission and before the operation was taken for the items of blood tests with multiple times in the analysis.

Study Type

Observational

Enrollment (Actual)

185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with a pathological diagnosis of craniopharyngioma

Description

Inclusion Criteria:

  • receive resective operation with a pathological diagnosis of craniopharyngioma in our hospital
  • enter our hospital between January 2013 and February 2021

Exclusion Criteria:

  • have a non-craniopharyngioma or unverified pathological diagnosis at discharge
  • have received surgical or radiological treatment on the sellar region
  • receive treatment of coagulation modulation, immunosuppressive agents or chemotherapeutic drugs
  • combine with other clinical emergencies including acute myocardial infarction, cerebral stroke, trauma and sepsis at admission
  • have been diagnosed with other tumors, hematological diseases, autoimmune diseases, liver failure or renal failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-hemorrhage group
Patients recognized as craniopharyngioma pathologically without tumoral hemorrhage observed during the operation
Hemorrhage group
Patients recognized as craniopharyngioma pathologically with tumoral hemorrhage observed during the operation
Other: intratumoral hemorrhage
Patients who were recognized as craniopharyngioma pathologically with tumoral hemorrhage observed during the operation were enrolled in the hemorrhage group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
craniopharyngioma with tumoral hemorrhage
Time Frame: during the operation
Current study is a case-control study whose primary outcome is tumoral hemorrhage observed during the operation, which devided the craniopharyngioma patients into hemorrhage group and non-hemorrhage group.
during the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Study Director: Kai Shu, MD, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 21, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kaishu1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Due to the sensitive nature of the questions asked in this study, survey respondents were assured raw data would remain confidential and would not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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