Heterotopic Ossification in Abdominal Incision and Pancreatic Cancer

Cancer of Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04049461
• Other study ID #: NMU-JSPH-PC-Ossification
• Status: Not yet recruiting
• Start date: September 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2019
• Source: Nanjing Medical University
• Contact: Jishu Wei, MD,PhD
• Phone: 086-025-68136891
• Email: weijishu[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Pancreas
• Ossification, Heterotopic
• Pancreatic Neoplasms
• Surgical Wound

Intervention

Diagnostic Test:
• Bone alkaline phosphatase
Hematologic indicators reflecting ossification.

Radiation:
• Abdominal CT scan
Observe whether HOAI occurs.

Locations

Country	Name	City	State
China	The first affiliated hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

Citak M, Grasmücke 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival	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
Primary	Incidence of HOAI	HOAI is determined by CT, whose CT number is similar to that of the same spine.	12 months
Primary	Bone alkaline phosphatase	Preoperative tests were performed and every three months postoperatively	12 months
Secondary	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