PancreatoduodenectomyNCT03754595
Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial
A study testing 3D Laparoscopic pancreatoduodenectomy and 2D Laparoscopic pancreatoduodenectomy in people with Pancreatoduodenectomy, run by Peking Union Medical College Hospital.
Trial summary
Pancreatic cancer is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatoduodenectomy
- What is being tested?
- 3D Laparoscopic pancreatoduodenectomy and 2D Laparoscopic pancreatoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 1 Dec 2021
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: >18yr, <75yr Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy Preoperative imaging assessment is resectable or borderline resectable -
Who cannot join
- Benign tumors of the head of pancreas Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis.
- conversion to laparotomy because of intraoperative difficulty
Trial locations and contacts
No sites are listed yet.
About this study
Pancreatic cancer is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Laparoscopic pancreatoduodenectomy is a standard radical procedure we are going to compare and discuss the advantages of 2D and 3D Laparoscopic pancreatoduodenectomy in our RCT study.
Read the detailed description
This study is to compare the efficiency and safety between 2D laparoscopic pancreatoduodenectomy and 2D laparoscopic pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to 2D laparoscopic or 3D laparoscopic group before the operation day . The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate.
- Conditions
- Pancreatoduodenectomy
- Being tested
- 3D Laparoscopic pancreatoduodenectomy, 2D Laparoscopic pancreatoduodenectomy
- Keywords
- 2D and 3D Laparoscopic pancreatoduodenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Laparoscopic pancreatoduodenectomyProcedure or surgery
Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy
2D Laparoscopic pancreatoduodenectomyProcedure or surgery
2D Laparoscopic pancreatoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| 2D Laparoscopic pancreatoduodenectomy | Active comparator | Patients with pancreatic cancer treated by 2D Laparoscopic pancreatoduodenectomy Receives: Procedure: 2D Laparoscopic pancreatoduodenectomy |
| 3D Laparoscopic pancreatoduodenectomy | Experimental | Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy Receives: Procedure: 3D Laparoscopic pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
overall survival duration after surgical treatment
Measured: 60 month
Secondary outcomes (1)
Overall complications
The proportion of all complications after operation accounted for the total number of patients
Measured: Up to postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatoduodenectomyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomy
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Menghua Dai, MD, Study director, Peking Union Medical Coll3ge hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754595
- Sponsor's protocol ID
- DaiMH
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 2D and 3D Laparoscopy in Laparoscopic Pancreaticoduodenectomy: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03754595
- Acronym / sponsor ID
- DaiMH
- Conditions
- Pancreatoduodenectomy
- Keywords
- 2D and 3D Laparoscopic pancreatoduodenectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 27 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.
Pancreatic cancer is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Laparoscopic pancreatoduodenectomy is a standard radical procedure we are going to compare and discuss the advantages of 2D and 3D Laparoscopic pancreatoduodenectomy in our RCT study.
Detailed description
This study is to compare the efficiency and safety between 2D laparoscopic pancreatoduodenectomy and 2D laparoscopic pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to 2D laparoscopic or 3D laparoscopic group before the operation day . The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomy
| Arm | Type | Receives |
|---|---|---|
| 2D Laparoscopic pancreatoduodenectomy | Active comparator | Procedure: 2D Laparoscopic pancreatoduodenectomyPatients with pancreatic cancer treated by 2D Laparoscopic pancreatoduodenectomy |
| 3D Laparoscopic pancreatoduodenectomy | Experimental | Procedure: 3D Laparoscopic pancreatoduodenectomyPatients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age: >18yr, <75yr Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy Preoperative imaging assessment is resectable or borderline resectable -
Key exclusion criteria (2 listed)
- Benign tumors of the head of pancreas Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis.
- conversion to laparotomy because of intraoperative difficulty
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 |
|---|---|---|
| 3D Laparoscopic pancreatoduodenectomyPatients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy | Procedure or surgery | 3D Laparoscopic pancreatoduodenectomy |
| 2D Laparoscopic pancreatoduodenectomy2D Laparoscopic pancreatoduodenectomy | Procedure or surgery | 2D Laparoscopic pancreatoduodenectomy |
Primary outcome
Overall survival
Time frame: 60 month
overall survival duration after surgical treatment
1 secondary outcome
Overall complications
Time frame: Up to postoperative 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Menghua Dai, MD study director
Peking Union Medical Coll3ge hospital
Questions about this trial
What is this clinical trial studying?
A study testing 3D Laparoscopic pancreatoduodenectomy and 2D Laparoscopic pancreatoduodenectomy in people with Pancreatoduodenectomy, run by Peking Union Medical College Hospital.
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 2 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 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Cheng Ding, MD (+861069152601, dingcheng13@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 60 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2018.