Heterotopic Ossification In Abdominal Incision And Pancreatic Cancer

Study Overview

Heterotopic Ossification in Abdominal Incision and Pancreatic Cancer

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

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.

Cancer of Pancreas
Ossification, Heterotopic

DIAGNOSTIC_TEST: Bone alkaline phosphatase
RADIATION: Abdominal CT scan

NMU-JSPH-PC-Ossification

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-08-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-08-06
First Submitted that Met QC Criteria 2019-08-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-08-08
First Posted (ACTUAL) 2019-08-08	Results First Posted N/A	Last Verified 2019-08

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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.

Participant Group/Arm

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.

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

Secondary Outcome Measures	Measure Description	Time Frame
Incidence of distant metastasis and local recurrence	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

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

Name: Jishu Wei, MD,PhD

Phone Number: 086-025-68136891

Email: weijishu@njmu.edu.cn

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Yi Miao, Prof., Pancreas Center, The First Affiliated Hospital of Nanjing Medical University

Publications

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

General Publications

Ghuman MS, Saggar K. Images in clinical medicine. Heterotopic ossification of a midline abdominal incision. N Engl J Med. 2014 Jul 31;371(5):464. doi: 10.1056/NEJMicm1312006. No abstract available.
Kim J, Kim Y, Jeong WK, Song SY, Cho OK. Heterotopic ossification developing in surgical incisions of the abdomen: analysis of its incidence and possible factors associated with its development. J Comput Assist Tomogr. 2008 Nov-Dec;32(6):872-6. doi: 10.1097/RCT.0b013e318159c617.
Koolen PG, Schreinemacher MH, Peppelenbosch AG. Heterotopic ossifications in midline abdominal scars: a critical review of the literature. Eur J Vasc Endovasc Surg. 2010 Aug;40(2):155-9. doi: 10.1016/j.ejvs.2010.03.010. Epub 2010 Apr 18.
Isaacson BM, Potter BK, Bloebaum RD, Epperson RT, Kawaguchi BS, Swanson TM, Pasquina PF. Link Between Clinical Predictors of Heterotopic Ossification and Histological Analysis in Combat-Injured Service Members. J Bone Joint Surg Am. 2016 Apr 20;98(8):647-57. doi: 10.2106/JBJS.15.00895.
Citak M, Grasmucke D, Suero EM, Cruciger O, Meindl R, Schildhauer TA, Aach M. The roles of serum alkaline and bone alkaline phosphatase levels in predicting heterotopic ossification following spinal cord injury. Spinal Cord. 2016 May;54(5):368-70. doi: 10.1038/sc.2015.211. Epub 2015 Dec 8.

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