Pancreatic CarcinomaMIOPPNCT03747588
The Comparision of Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer
A study testing Minimally-invasive pancreaticoduodenectomy and Open pancreaticoduodenectomy in people with Pancreatic Carcinoma and Surgery, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Minimally invasive pancreaticoduodenectomy remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing minimally-invasive with open pancreaticoduodenectomy, especially for malignant tumors.The aim of this study was to compare minimally invasive and open… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Carcinoma, Surgery
- What is being tested?
- Minimally-invasive pancreaticoduodenectomy and Open pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, Beijing Municipality
Dai Menghua
About this study
Official title: The Effect and Safety of Comparision Between Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer : A Randomized Prospective Trial
Minimally invasive pancreaticoduodenectomy remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing minimally-invasive with open pancreaticoduodenectomy, especially for malignant tumors.The aim of this study was to compare minimally invasive and open pancreatoduodenectomy for short-term outcomes and long-term follow-up in a randomized trial.
Read the detailed description
This study is to compare the efficiency and safety between minimally invasive (including laparoscopic and robotic) and open 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 minimally-invasive or open group before the operation day. The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate as well as disease free survival and overall survival.
- Conditions
- Pancreatic Carcinoma, Surgery
- Being tested
- Minimally-invasive pancreaticoduodenectomy, Open pancreaticoduodenectomy
- Keywords
- minimally-invasive pancreaticoduodenectomy, open pancreaticoduodenectomy, pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally-invasive pancreaticoduodenectomyProcedure or surgery
Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor
Open pancreaticoduodenectomyOther
Open pancreaticoduodenectomy for resection of pancreatic tumor
| Study group | Role | What they receive |
|---|---|---|
| Minimally-invasive Pancreaticoduodenectomy | Experimental | MIPD Receives: Procedure: Minimally-invasive pancreaticoduodenectomy |
| Open Pancreaticoduodenectomy | Placebo comparator | OPD Receives: Other: Open pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complications
The proportion of all complications after operation accounted for the total number of patients
Measured: Up to postoperative 30 days
Pancreatic fistula
The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
Measured: Up to postoperative 30 days
Intra-abdominal bleeding
The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
Measured: Up to postoperative 30 days
Intra-abdominal infection
Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
Measured: Up to postoperative 30 days
Secondary outcomes (1)
Length of hospital stay (day)
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measured: Up to postoperative 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Dec 2018
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CarcinomaStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747588
- Sponsor's protocol ID
- Pumch06342
- Acronym
- MIOPP
- Status last verified
- Sep 2022
- First submitted
- 16 Nov 2018
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Comparision Between Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer : A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT03747588
- Acronym / sponsor ID
- MIOPP / Pumch06342
- Conditions
- Pancreatic Carcinoma, Surgery
- Keywords
- minimally-invasive pancreaticoduodenectomy, open pancreaticoduodenectomy, pancreatic cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 20 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.
Minimally invasive pancreaticoduodenectomy remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing minimally-invasive with open pancreaticoduodenectomy, especially for malignant tumors.The aim of this study was to compare minimally invasive and open pancreatoduodenectomy for short-term outcomes and long-term follow-up in a randomized trial.
Detailed description
This study is to compare the efficiency and safety between minimally invasive (including laparoscopic and robotic) and open 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 minimally-invasive or open group before the operation day. The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate as well as disease free survival and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally-invasive Pancreaticoduodenectomy | Experimental | Procedure: Minimally-invasive pancreaticoduodenectomyMIPD |
| Open Pancreaticoduodenectomy | Placebo comparator | Other: Open pancreaticoduodenectomyOPD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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 (3 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 |
|---|---|---|
| Minimally-invasive pancreaticoduodenectomyMinimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor | Procedure or surgery | Minimally-invasive Pancreaticoduodenectomy |
| Open pancreaticoduodenectomyOpen pancreaticoduodenectomy for resection of pancreatic tumor | Other | Open Pancreaticoduodenectomy |
Primary outcome
Overall complications
Time frame: Up to postoperative 30 days
The proportion of all complications after operation accounted for the total number of patients
Pancreatic fistula
Time frame: Up to postoperative 30 days
The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
Intra-abdominal bleeding
Time frame: Up to postoperative 30 days
The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
Intra-abdominal infection
Time frame: Up to postoperative 30 days
Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
1 secondary outcome
Length of hospital stay (day)
Time frame: Up to postoperative 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally-invasive pancreaticoduodenectomy and Open pancreaticoduodenectomy in people with Pancreatic Carcinoma and Surgery, run by Peking Union Medical College 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Oct 2022. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Menghua Dai, MD (+861069152600, DaiMH@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall complications (time frame: Up to postoperative 30 days). The study lists 4 primary outcomes in all. 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 3 Oct 2022.