Pancreatic Ductal AdenocarcinomaNCT04211948
Clinical Study Between Robotic and Open Surgery in Patients With Pancreatic Cancer
A study testing robotic surgery and open surgery in people with Pancreatic Ductal Adenocarcinoma and Minimally Invasive Surgery, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether robotic surgery has limitations in terms of patient age, tumor size, location, and vascular relationship when compared to open surgery for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Minimally Invasive Surgery
- What is being tested?
- robotic surgery and open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to Dec 2024
- 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
- Diagnosed pancreatic ductal adenocarcinoma
- Patients and their families volunteered to test and signed informed consent.
Who cannot join
- Preoperative exclusion:
- Patients with metastasis (M1)
- Patients with tumor recurrence
- Patients with artery and/or vein invasion and can't perform radical resection and reconstruction
- Patients with poor cardiopulmonary function cannot tolerate surgery;
- receive neoadjuvant radiotherapy and chemotherapy before surgery;
Show all 13Show fewer
- The patient or family member refuses to join the group;
- Pregnant patients
- Intraoperative exclusion:
- Intraoperative exploration of metastases in other parts besides the primary lesion
- Other organs malignant tumors metastasize to the pancreas
- Postoperative exclusion:
- pathology confirmed non-pancreatic ductal adenocarcinoma
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200032
Kai Qin, 0086-(0)21-64370045 ext. +8613671917328, qinkai310@sina.com
About this study
Official title: Prospective Cohort Study Comparing Robotic and Open Surgery for Pancreatic Cancer
The purpose of this study is to determine whether robotic surgery has limitations in terms of patient age, tumor size, location, and vascular relationship when compared to open surgery for pancreatic cancer. Whether robotic surgery has advantages over intraoperative bleeding, operative time, postoperative complications (bleeding, infection, pancreatic fistula) and postoperative hospital stays compared to open surgery.And the differences in lymph nodes harvest and postoperative survival between two groups.
- Being tested
- robotic surgery, open surgery
- Keywords
- Robotic assisted surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic surgeryProcedure or surgery
Pancreatectomy with robotic assisted system
open surgeryProcedure or surgery
Traditional open pancreatectomy
| Study group | Role | What they receive |
|---|---|---|
| robotic pancreatectomy | Experimental | robotic pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy) Receives: Procedure: robotic surgery |
| open surgery | Active comparator | open pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy) Receives: Procedure: open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year overall survival rate
Measured: 1 year post-operation
3 years overall survival rate
Measured: 3 years post-operation
Secondary outcomes (2)
Postoperative Complications
pancreatic fistula, bile leakage, hemorrhage, DGE, etc
Measured: Within 90 days or before discharge
1, 3years disease free survival rate
Measured: 1,3years post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Mar 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Kai Qin, Ruijin Hospital
- Investigators
- Kai Qin, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211948
- Sponsor's protocol ID
- HBP-RWR-001
- Status last verified
- Apr 2021
- First submitted
- 29 Nov 2019
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- 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 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study Comparing Robotic and Open Surgery for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04211948
- Acronym / sponsor ID
- HBP-RWR-001
- Keywords
- Robotic assisted surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Dec 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.
The purpose of this study is to determine whether robotic surgery has limitations in terms of patient age, tumor size, location, and vascular relationship when compared to open surgery for pancreatic cancer. Whether robotic surgery has advantages over intraoperative bleeding, operative time, postoperative complications (bleeding, infection, pancreatic fistula) and postoperative hospital stays compared to open surgery.And the differences in lymph nodes harvest and postoperative survival between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic pancreatectomy | Experimental | Procedure: robotic surgeryrobotic pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy) |
| open surgery | Active comparator | Procedure: open surgeryopen pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed pancreatic ductal adenocarcinoma
- Patients and their families volunteered to test and signed informed consent.
Key exclusion criteria (13 listed)
- Preoperative exclusion:
- Intraoperative exclusion:
- Postoperative exclusion:
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 |
|---|---|---|
| robotic surgeryPancreatectomy with robotic assisted system | Procedure or surgery | robotic pancreatectomy |
| open surgeryTraditional open pancreatectomy | Procedure or surgery | open surgery |
Primary outcome
1 year overall survival rate
Time frame: 1 year post-operation
3 years overall survival rate
Time frame: 3 years post-operation
2 secondary outcomes
Postoperative Complications
Time frame: Within 90 days or before discharge
1, 3years disease free survival rate
Time frame: 1,3years post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Ductal Adenocarcinoma
Not yet recruitingPhase 1/2
A Study of Perioperative Navlimetostat Combined With Modified FOLFIRINOX in Patients With MTAP-Deleted Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Active, not recruitingPhase 1/2
A Study of GKL-006 Injection in Patients With Advanced Pancreatic Cancer
Advanced Pancreatic Cancer, Ductal Adenocarcinoma of Pancreas
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingPhase 1
M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
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.
Kai Qin principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic surgery and open surgery in people with Pancreatic Ductal Adenocarcinoma and Minimally Invasive Surgery, run by Ruijin 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 2 inclusion and 13 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 9 Apr 2021. 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 Kai Qin, Doctor (0086-(0)21-64370045 ext. 670902, qinkai310@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year overall survival rate (time frame: 1 year post-operation). 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?
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 9 Apr 2021.