Cancer of PancreasNCT04049461
Heterotopic Ossification in Abdominal Incision and Pancreatic Cancer
An observational study of Cancer of Pancreas and Ossification, Heterotopic, run by Nanjing Medical University at 1 site in China.
Trial summary
To investigate whether pancreatic cancer is the cause of heterotopic ossification of abdominal incision. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer of Pancreas, Ossification, Heterotopic
- What is being tested?
- Bone alkaline phosphatase and Abdominal CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese Han population
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: The Causes of Heterotopic Ossification in Abdominal Incision After Pancreatic Surgery：A Single-center Prospective Study
To investigate whether pancreatic cancer is the cause of heterotopic ossification of abdominal incision.
Read the 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.
- Conditions
- Cancer of Pancreas, Ossification, Heterotopic
- Being tested
- Bone alkaline phosphatase, Abdominal CT scan
- Keywords
- Cancer of Pancreas, Ossification, Heterotopic, Abdominal incision
- Medical subject headings
- Pancreatic Neoplasms, Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone alkaline phosphataseDiagnostic test
Hematologic indicators reflecting ossification.
Abdominal CT scanRadiation
Observe whether HOAI occurs.
| Study group | Role | What they receive |
|---|---|---|
| PDAC Group | Radical operations were performed through central abdominal incisions. The postoperative pathology was pancreatic ductal adenocarcinoma. Receives: Diagnostic Test: Bone alkaline phosphatase; Radiation: Abdominal CT scan | |
| Benign Group | The abdominal midline incision was performed and the postoperative pathology was benign. Receives: Diagnostic Test: Bone alkaline phosphatase; Radiation: Abdominal CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HOAI
HOAI is determined by CT, whose CT number is similar to that of the same spine.
Measured: 12 months
Bone alkaline phosphatase
Preoperative tests were performed and every three months postoperatively
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Miao, Prof., Nanjing Medical University
- Investigators
- Yi Miao, Prof., Principal investigator, Pancreas Center, The First Affiliated Hospital of Nanjing Medical UniversityJunli Wu, MD,PHD, Study director, Pancreas Center, The First Affiliated Hospital of Nanjing Medical UniversityJishu Wei, MD,PHD, Principal investigator, Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049461
- Sponsor's protocol ID
- NMU-JSPH-PC-Ossification
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25075838Kim 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.
PubMed 19204446Koolen 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.
PubMed 20400341Isaacson 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.
PubMed 27098323Citak 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.
PubMed 26643987
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Causes of Heterotopic Ossification in Abdominal Incision After Pancreatic Surgery：A Single-center Prospective Study
- ClinicalTrials.gov ID
- NCT04049461
- Acronym / sponsor ID
- NMU-JSPH-PC-Ossification
- Conditions
- Cancer of Pancreas, Ossification, Heterotopic
- Keywords
- Cancer of Pancreas, Ossification, Heterotopic, Abdominal incision
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDAC Group | – | Diagnostic Test: Bone alkaline phosphatase, Radiation: Abdominal CT scanRadical operations were performed through central abdominal incisions. The postoperative pathology was pancreatic ductal adenocarcinoma. |
| Benign Group | – | Diagnostic Test: Bone alkaline phosphatase, Radiation: Abdominal CT scanThe abdominal midline incision was performed and the postoperative pathology was benign. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese Han population
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- Refusing to join the study
- Previous history of malignant tumor
- Previous history of midabdominal incision
- Abnormal calcium and phosphorus metabolism
- Distant metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone alkaline phosphataseHematologic indicators reflecting ossification. | Diagnostic test | Benign Group, PDAC Group |
| Abdominal CT scanObserve whether HOAI occurs. | Radiation | Benign Group, PDAC Group |
Primary outcome
Incidence of HOAI
Time frame: 12 months
HOAI is determined by CT, whose CT number is similar to that of the same spine.
Bone alkaline phosphatase
Time frame: 12 months
Preoperative tests were performed and every three months postoperatively
1 secondary outcome
Incidence of distant metastasis and local recurrence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Background: PubMed 25075838Ghuman 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.
- Background: PubMed 19204446Kim 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.
- Background: PubMed 20400341Koolen 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.
- Background: PubMed 27098323Isaacson 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.
- Background: PubMed 26643987Citak 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Miao, Prof. principal investigator
Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
Junli Wu, MD,PHD study director
Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
Jishu Wei, MD,PHD principal investigator
Pancreas Center, The First Affiliated Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Pancreas and Ossification, Heterotopic, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jishu Wei, MD,PhD (086-025-68136891, weijishu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HOAI (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049461, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.