Clinical trial NCT04049461: Heterotopic Ossification in Abdominal Incision and Pancreatic Cancer
Official title: The Causes of Heterotopic Ossification in Abdominal Incision After Pancreatic Surgery：A Single-center Prospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer of Pancreas
Ossification, Heterotopic
Keywords: Cancer of Pancreas
Ossification, Heterotopic
Abdominal incision
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese Han population

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of HOAI
timeFrame: 12 months
measure: Bone alkaline phosphatase
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of distant metastasis and local recurrence
timeFrame: 12 months
Other outcomes:
measure: Overall survival
timeFrame: 5 years
Locations:
city: Nanjing
country: China
facility: The first affiliated hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
name: Yi Miao, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
name: Junli Wu, MD,PHD
role: STUDY_DIRECTOR
affiliation: Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
name: Jishu Wei, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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.
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.
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.
citation: 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.