Heterotopic Ossification in Abdominal Incision and Pancreatic Cancer

August 6, 2019 updated by: Yi Miao, Prof., Nanjing Medical University

The Causes of Heterotopic Ossification in Abdominal Incision After Pancreatic Surgery：A Single-center Prospective Study

To investigate whether pancreatic cancer is the cause of heterotopic ossification of abdominal incision.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Heterotopic ossification of abdominal incision (HOAI) has long been regarded as a rare complication after general surgery. However,according to our retrospective analysis. HOAI was more frequently observed in the malignancy group (33/121 cases, 27.3%) than in the non- malignancy group. Because of the many biases in the retrospective analysis, the result was not widely shared.

The purpose of this prospective study is to confirm that pancreatic cancer is the cause of heterotopic ossification of abdominal incisions. According to postoperative pathology, the patients were divided into two groups: pancreatic cancer group and benign diseases group.The researchers will observe whether patients develop heterotopic ossification of the abdominal incision one year after surgery to conclude.

Study Type

Observational

Enrollment (Anticipated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese Han population

Description

Inclusion Criteria:

  • Obtain informed consent from the patients.
  • The patient's abdominal incision was double-closed with continuous suture of linea alba and fascia with absorbable suture, and skin was sutured with skin staples.

Exclusion Criteria:

  • Refusing to join the study
  • Previous history of malignant tumor
  • Previous history of midabdominal incision
  • Abnormal calcium and phosphorus metabolism
  • Distant metastasis
  • Palliative operation
  • performing neoadjuvant chemotherapy

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PDAC Group
Radical operations were performed through central abdominal incisions. The postoperative pathology was pancreatic ductal adenocarcinoma.
Diagnostic test: Bone alkaline phosphatase
Hematologic indicators reflecting ossification.
Radiation: Abdominal CT scan
Observe whether HOAI occurs.
Benign Group
The abdominal midline incision was performed and the postoperative pathology was benign.
Diagnostic test: Bone alkaline phosphatase
Hematologic indicators reflecting ossification.
Radiation: Abdominal CT scan
Observe whether HOAI occurs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of HOAI
Time Frame: 12 months
HOAI is determined by CT, whose CT number is similar to that of the same spine.
12 months
Bone alkaline phosphatase
Time Frame: 12 months
Preoperative tests were performed and every three months postoperatively
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of distant metastasis and local recurrence
Time Frame: 12 months
Patients with pancreatic cancer were divided into HOAI and non-HOAI groups to determine whether there were differences in the incidence of distant metastasis and local recurrence between the two groups.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Patients with pancreatic cancer were divided into HOAI and non-HOAI groups to determine whether there were differences between the OS of two groups.
5 years

Collaborators and Investigators

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

Sponsor

Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 8, 2019

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-JSPH-PC-Ossification

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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