Heterotopic Ossification in Abdominal Incision and Pancreatic Cancer

Not yet recruiting

• Conditions: Cancer of Pancreas; Ossification, Heterotopic
• Interventions: Diagnostic Test: Bone alkaline phosphatase; Radiation: Abdominal CT scan

• Registration Number: NCT04049461
• Lead Sponsor: Nanjing Medical University

Brief Summary

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

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 Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-06
• Last Update Submitted: 2019-08-06
• Study First Posted: 2019-08-08
• Last Update Posted: 2019-08-08
• Study Start: 2019-09-01
• Primary Completion: 2020-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PDAC Group	Bone alkaline phosphatase	Radical operations were performed through central abdominal incisions. The postoperative pathology was pancreatic ductal adenocarcinoma.
Benign Group	Abdominal CT scan	The abdominal midline incision was performed and the postoperative pathology was benign.
PDAC Group	Abdominal CT scan	Radical operations were performed through central abdominal incisions. The postoperative pathology was pancreatic ductal adenocarcinoma.
Benign Group	Bone alkaline phosphatase	The abdominal midline incision was performed and the postoperative pathology was benign.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of distant metastasis and local recurrence	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.

Trial Locations

Locations (1)

The first affiliated hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China