Heterotopic Ossification in Abdominal Incision and Pancreatic Cancer

NCT04049461 | Unknown

• 1 other identifier: NMU-JSPH-PC-Ossification
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer of Pancreas; Ossification, Heterotopic

Keywords

Cancer of Pancreas; Ossification, Heterotopic; Abdominal incision

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of distant metastasis and local recurrence

  12 months

Other Outcomes (1)

• Overall survival

  5 years

Study Arms (2)

PDAC Group

Radical operations were performed through central abdominal incisions. The postoperative pathology was pancreatic ductal adenocarcinoma.

Diagnostic Test: Bone alkaline phosphatase; Radiation: Abdominal CT scan

Benign Group

The abdominal midline incision was performed and the postoperative pathology was benign.

Diagnostic Test: Bone alkaline phosphatase; Radiation: Abdominal CT scan

Interventions

Bone alkaline phosphatase DIAGNOSTIC_TEST

Hematologic indicators reflecting ossification.

Benign Group; PDAC Group

Abdominal CT scan RADIATION

Observe whether HOAI occurs.

Benign Group; PDAC Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese Han population

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The first affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (5)

• 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.

  PMID: 25075838 BACKGROUND

• 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.

  PMID: 19204446 BACKGROUND

• 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.

  PMID: 20400341 BACKGROUND

• 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.

  PMID: 27098323 BACKGROUND

• 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.

  PMID: 26643987 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The ossification patients were sequenced with informed consent . Promise to keep their personal information confidential.

MeSH Terms

Conditions

Pancreatic Neoplasms; Ossification, Heterotopic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Miao, Prof.

  Pancreas Center, The First Affiliated Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Junli Wu, MD,PHD

  Pancreas Center, The First Affiliated Hospital of Nanjing Medical University

  STUDY DIRECTOR

• Jishu Wei, MD,PHD

  Pancreas Center, The First Affiliated Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jishu Wei, MD,PhD

CONTACT

086-025-68136891; weijishu@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pancreas Center

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2025
• Last Updated: August 8, 2019

Record last verified: 2019-08

Locations

CN (1)