Pancreatic CancerNCT03749005
Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Zhujiang Hospital at 1 site in China.
Trial summary
The aim of the multi-centre study is to evaluate correctly the impact of three dimensional visualization on operation strategy and complications for Pancreatic Cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2017to 30 Aug 2020
- 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 70 years
- All sexes
- Adult, Older adult
Study population: The patients with Pancreatic Cancer.
Who may be able to join
- 1.18 years≤ Age ≤70 years 2.Compling with the diagnosis criteria of Pancreatic Cancer. 3.Primary Pancreatic Cancer without metastasis. 4.The patients are volunteered for the study.
Who cannot join
- Patients with mental illness.
- Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
- The patients refused to take part in the study.
- There are other co-existed malignant tumors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of The Southern Medical University
Guangzhou, Guangdong, 510282
Chihua Fang, MD, (+86)2062782568, s_mountain@126.com
About this study
The aim of the multi-centre study is to evaluate correctly the impact of three dimensional visualization on operation strategy and complications for Pancreatic Cancer.
Read the detailed description
Because of the complexity of Pancreatic Cancer, the limitations of 2D images of CT/MRI and the uncertainty of surgeons'experience, it is difficult for the surgeons to diagnosis and assess the operation strategy accurately based on traditional 2D imaging(CT/MRI).The aim of the multi-centre study is to evaluate correctly the impact of three-dimensional visualization on operation strategy and complications for Pancreatic Cancer.
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Three-dimensional Visualization
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on operation strategy of three dimensional visualization technique
Firstly, the operation strategies based on original CT or MRI image data will be made by the team, Secondly, the operation strategies based on three dimensional reconstruction models will be made by the team, then, actually surgical strategies will be recorded. The change of operation strategy will be assessed by comparing the strategy of the 2D model and 3D model. The change rate of operation strategy will be recorded and presented as percentage.
Measured: 30 days
Secondary outcomes (2)
Impact on complication of three dimensional visualization technique
The early postoperative complication and mortality are defined as the event observed within 30 days after surgerypostoperative bleeding, biliary fistula, ascites, postoperative liver failure, renal dysfunction, pleural effusion, abdominal cavity infection, abdominal abscess, incision infection, the occurrence cases of each complication (number) will be recorded.
Measured: 30 days
1-year disease free survival rate
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 posted21 Nov 2018
- Study start18 Apr 2017
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749005
- Sponsor's protocol ID
- 201801
- Status last verified
- Apr 2018
- First submitted
- 19 Nov 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu X, Wang D, Xiang N, Pan M, Jia F, Yang J, Fang C. Augmented reality-assisted navigation system contributes to better intraoperative and short-time outcomes of laparoscopic pancreaticoduodenectomy: a retrospective cohort study. Int J Surg. 2023 Sep 1;109(9):2598-2607. doi: 10.1097/JS9.0000000000000536.
PubMed 37338535Tao H, Zeng X, Lin W, Wang Z, Lin J, Li J, Qian Y, Yang J, Fang C. Indocyanine green fluorescence imaging to localize insulinoma and provide three-dimensional demarcation for laparoscopic enucleation: a retrospective single-arm cohort study. Int J Surg. 2023 Apr 1;109(4):821-828. doi: 10.1097/JS9.0000000000000319.
PubMed 37026828
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Three-dimensional Visualization on Operation Strategy and Complications for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03749005
- Acronym / sponsor ID
- 201801
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Three-dimensional Visualization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 21 Nov 2018 (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.
The aim of the multi-centre study is to evaluate correctly the impact of three dimensional visualization on operation strategy and complications for Pancreatic Cancer.
Detailed description
Because of the complexity of Pancreatic Cancer, the limitations of 2D images of CT/MRI and the uncertainty of surgeons'experience, it is difficult for the surgeons to diagnosis and assess the operation strategy accurately based on traditional 2D imaging(CT/MRI).The aim of the multi-centre study is to evaluate correctly the impact of three-dimensional visualization on operation strategy and complications for Pancreatic Cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients with Pancreatic Cancer.
Key inclusion criteria (1 listed)
- 1.18 years≤ Age ≤70 years 2.Compling with the diagnosis criteria of Pancreatic Cancer. 3.Primary Pancreatic Cancer without metastasis. 4.The patients are volunteered for the study.
Key exclusion criteria (4 listed)
- Patients with mental illness.
- Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
- The patients refused to take part in the study.
- There are other co-existed malignant tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact on operation strategy of three dimensional visualization technique
Time frame: 30 days
Firstly, the operation strategies based on original CT or MRI image data will be made by the team, Secondly, the operation strategies based on three dimensional reconstruction models will be made by the team, then, actually surgical strategies will be recorded. The change of operation strategy will be assessed by comparing the strategy of the 2D model and 3D model. The change rate of operation strategy will be recorded and presented as percentage.
2 secondary outcomes
Impact on complication of three dimensional visualization technique
Time frame: 30 days
1-year disease free survival rate
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 21 Nov 2018.
- Derived from this study: PubMed 37338535Wu X, Wang D, Xiang N, Pan M, Jia F, Yang J, Fang C. Augmented reality-assisted navigation system contributes to better intraoperative and short-time outcomes of laparoscopic pancreaticoduodenectomy: a retrospective cohort study. Int J Surg. 2023 Sep 1;109(9):2598-2607. doi: 10.1097/JS9.0000000000000536.
- Derived from this study: PubMed 37026828Tao H, Zeng X, Lin W, Wang Z, Lin J, Li J, Qian Y, Yang J, Fang C. Indocyanine green fluorescence imaging to localize insulinoma and provide three-dimensional demarcation for laparoscopic enucleation: a retrospective single-arm cohort study. Int J Surg. 2023 Apr 1;109(4):821-828. doi: 10.1097/JS9.0000000000000319.
Related trials for Pancreatic Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors.
Pancreatic Ductal Adenocarcinoma, Esophageal Cancer
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
RecruitingPhase 1/2
Phase 1/2, Open-label Study of ETX-929, a KRAS Inhibitor in Participants With Advanced Solid Tumors
Metastatic Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 1
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor
Active, not recruitingPhase 2
Liquid Biopsy (ctDNA) Guided Treatment in Localized Pancreatic Cancer: Neoadjuvant CTX vs. Upfront Surgery
Pancreatic Cancer, Circulating Tumor Cell
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.
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 Pancreatic Cancer, run by Zhujiang Hospital 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 1 inclusion and 4 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 21 Nov 2018. 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 Chihua Fang, M.D.;Ph.D ((+86)2062782568, s_mountain@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on operation strategy of three dimensional visualization technique (time frame: 30 days). 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 NCT03749005, which also lists 2 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 21 Nov 2018.