Pancreatic CancerNCT05755607
A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD
A study testing laparoscopic pancreaticoduodenectomy and Robot Pancreaticoduodenectomy in people with Pancreatic Cancer and Common Bile Duct Diseases, run by The First Affiliated Hospital of University of South China.
Trial summary
laparoscopic pancreaticoduodenectomy(LPD) and Robot Pancreaticoduodenectomy (RPD), as two minimally invasive methods of pancreaticoduodenectomy(PD), have obvious advantages over traditional open pancreaticoduodenectomy(OPD) in terms of reducing surgical trauma and hospitalization time, but there are few studies on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Common Bile Duct Diseases, Periampullary Carcinoma
- What is being tested?
- laparoscopic pancreaticoduodenectomy and Robot Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jul 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Preoperative imaging suggested the presence of space occupying in the head of the pancreas, ampullary abdomen, and distal common bile duct tumor lesions to be treated with Pancreaticoduodenectomy
- No distant transfer
- No significant vascular invasion was received
Who cannot join
- With tumors of other organs
- Patients unable to tolerate anesthesia and operation due to serious abnormalities in functions of heart, lung and other important organs
- Patients found intraoperative peripheral organ metastasis combined with excision of other organs or found intraoperative radical excision could not be performed and underwent palliative drainage surgery or end the surgery
- Preoperative adjuvant therapy was given
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Prospective Randomized Controlled Study of Robot Pancreaticoduodenectomy Versus Laparoscopic Pancreaticoduodenectomy
laparoscopic pancreaticoduodenectomy(LPD) and Robot Pancreaticoduodenectomy (RPD), as two minimally invasive methods of pancreaticoduodenectomy(PD), have obvious advantages over traditional open pancreaticoduodenectomy(OPD) in terms of reducing surgical trauma and hospitalization time, but there are few studies on their perioperative safety and prognostic effects.However, there are few studies on the perioperative safety and prognostic effects of both procedures. In this trial, the perioperative data and prognosis of both procedures were collected and analyzed through a prospective, multicenter approach to investigate the advantages and disadvantages of both procedures.
Read the detailed description
In this trial, subjects proposed for PD were randomly divided into two groups, LPD and RPD, according to inclusion and exclusion criteria. Patients in both groups were operated and received perioperative management under the same surgical team and were operated according to the standard PD surgical approach. Subsequently, perioperative clinical data and long-term prognostic data of subjects in both groups will be collected and statistically analyzed to explore a better surgical approach.
- Being tested
- laparoscopic pancreaticoduodenectomy, Robot Pancreaticoduodenectomy
- Keywords
- Robot pancreaticoduodenectomy, laparoscopic pancreaticoduodenectomy, randomized controlled trial, Safety and Efficacy
- Medical subject headings
- Pancreatic Neoplasms, Common Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic pancreaticoduodenectomyProcedure or surgery
The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.
Robot PancreaticoduodenectomyProcedure or surgery
The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic pancreaticoduodenectomy group | Other | The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure. Receives: Procedure: laparoscopic pancreaticoduodenectomy |
| Robot Pancreaticoduodenectomy | Other | The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure. Receives: Procedure: Robot Pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of long-term Survival
Survival will be documented 3 years after surgery
Measured: 3 years
Secondary outcomes (2)
Unplanned re-admission rate after discharge within 30 days
Serious discomfort requiring re-admission within 30 days after discharge will be recorded, and the safety of the surgical method will be evaluated by this indicator
Measured: 3 months
Incidence of postoperative complications
During hospitalization, common complications of pancreaticoduodenectomy, such as postoperative pancreatic fistula, bile leak, gastrojejunostomy leak, and delayed gastric emptying, will be recorded according to the international diagnostic criteria to evaluate the short-term safety of this surgical approach
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- The key difference in treatment between the two groups is the surgical approach, with the LPD group undergoing laparoscopic-assisted pancreaticoduodenectomy and the RPD group undergoing robotic-assisted pancreaticoduodenectomy, with all treatments remaining the same except for the surgical approach.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of South China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guodong Chen, PhD, Study chair, The First Affiliated Hospital of University of South China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755607
- Sponsor's protocol ID
- USC-4310-3
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 6 Mar 2023
- 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 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Controlled Study of Robot Pancreaticoduodenectomy Versus Laparoscopic Pancreaticoduodenectomy
- ClinicalTrials.gov ID
- NCT05755607
- Acronym / sponsor ID
- USC-4310-3
- Keywords
- Robot pancreaticoduodenectomy, laparoscopic pancreaticoduodenectomy, randomized controlled trial, Safety and Efficacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of South ChinaUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 6 Mar 2023 (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.
laparoscopic pancreaticoduodenectomy(LPD) and Robot Pancreaticoduodenectomy (RPD), as two minimally invasive methods of pancreaticoduodenectomy(PD), have obvious advantages over traditional open pancreaticoduodenectomy(OPD) in terms of reducing surgical trauma and hospitalization time, but there are few studies on their perioperative safety and prognostic effects.However, there are few studies on the perioperative safety and prognostic effects of both procedures. In this trial, the perioperative data and prognosis of both procedures were collected and analyzed through a prospective, multicenter approach to investigate the advantages and disadvantages of both procedures.
Detailed description
In this trial, subjects proposed for PD were randomly divided into two groups, LPD and RPD, according to inclusion and exclusion criteria. Patients in both groups were operated and received perioperative management under the same surgical team and were operated according to the standard PD surgical approach. Subsequently, perioperative clinical data and long-term prognostic data of subjects in both groups will be collected and statistically analyzed to explore a better surgical approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The key difference in treatment between the two groups is the surgical approach, with the LPD group undergoing laparoscopic-assisted pancreaticoduodenectomy and the RPD group undergoing robotic-assisted pancreaticoduodenectomy, with all treatments remaining the same except for the surgical approach.
| Arm | Type | Receives |
|---|---|---|
| laparoscopic pancreaticoduodenectomy group | Other | Procedure: laparoscopic pancreaticoduodenectomyThe laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure. |
| Robot Pancreaticoduodenectomy | Other | Procedure: Robot PancreaticoduodenectomyThe robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Preoperative imaging suggested the presence of space occupying in the head of the pancreas, ampullary abdomen, and distal common bile duct tumor lesions to be treated with Pancreaticoduodenectomy
- No distant transfer
- No significant vascular invasion was received
Key exclusion criteria (4 listed)
- With tumors of other organs
- Patients unable to tolerate anesthesia and operation due to serious abnormalities in functions of heart, lung and other important organs
- Patients found intraoperative peripheral organ metastasis combined with excision of other organs or found intraoperative radical excision could not be performed and underwent palliative drainage surgery or end the surgery
- Preoperative adjuvant therapy was given
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 |
|---|---|---|
| laparoscopic pancreaticoduodenectomyThe laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure. | Procedure or surgery | laparoscopic pancreaticoduodenectomy group |
| Robot PancreaticoduodenectomyThe robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure. | Procedure or surgery | Robot Pancreaticoduodenectomy |
Primary outcome
Rate of long-term Survival
Time frame: 3 years
Survival will be documented 3 years after surgery
2 secondary outcomes
Unplanned re-admission rate after discharge within 30 days
Time frame: 3 months
Incidence of postoperative complications
Time frame: 2 months
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 6 Mar 2023.
- 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.
Guodong Chen, PhD study chair
The First Affiliated Hospital of University of South China
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic pancreaticoduodenectomy and Robot Pancreaticoduodenectomy in people with Pancreatic Cancer and Common Bile Duct Diseases, run by The First Affiliated Hospital of University of South 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 4 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: opening soon, as of the sponsor's last update on 6 Mar 2023. 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?
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 Guodong Chen, PhD ((+86)15211450345, Chenguodong@usc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of long-term Survival (time frame: 3 years). 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 6 Mar 2023.