Pancreatic Neuroendocrine TumorsNCT02125929
Comparative Study of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neoplasms
A study testing Robotic surgery, Laparoscopic surgery and Open surgery in people with Pancreatic Neuroendocrine Tumors, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To determine the efficacy and safety of robotic, laparoscopic and open surgery for enucleation of benign pancreatic neuroendocrine tumors Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Neuroendocrine Tumors
- What is being tested?
- Robotic surgery, Laparoscopic surgery and Open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Dec 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old
- Body Mass Index<30
- Preoperative diagnosis of resectable benign Pancreatic Neuroendocrine Tumors
- Tumor type: Non-functional pancreatic endocrine tumours and insulinomas
- largest diameter < 4cm
- Preoperative CT showed no evidence that tumor was connected with main pancreatic duct
Who cannot join
- Severe cardio/pulmonary complications
- Other pancreatic diseases, including pancreatitis and pancreatic cancer
- Multiple pancreatic neuroendocrine tumors
- Distant metastasis
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery, Peking Union medical school hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Comparative Study of the Efficacy and Safety Outcomes of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neuroendocrine Tumors
To determine the efficacy and safety of robotic, laparoscopic and open surgery for enucleation of benign pancreatic neuroendocrine tumors
Read the detailed description
The study was prospective and retrospective, non-randomized study included patients with benign pancreatic neoplasms. The robotic arm consecutively includes patients underwent robotic enucleation surgery and expected number in this arm is 50. The laparoscopic and open surgery arms retrospectively include case from the year 2004. The number of patients for laparoscopic and open surgery arms are 50 and 100, respectively.
- Conditions
- Pancreatic Neuroendocrine Tumors
- Being tested
- Robotic surgery, Laparoscopic surgery, Open surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic surgeryProcedure or surgery
Robotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors
Laparoscopic surgeryProcedure or surgery
Laparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors
Open surgeryProcedure or surgery
Open surgery: enucleation benign Pancreatic Neuroendocrine Tumors
| Study group | Role | What they receive |
|---|---|---|
| robotic arm | Experimental | robotic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50 Receives: Procedure: Robotic surgery |
| Laparoscopic surgery | Experimental | laparoscopic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50 Receives: Procedure: Laparoscopic surgery |
| Open surgery | Experimental | Open surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 100 Receives: Procedure: Open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic fistula rate
Measured: up to 30 days
Secondary outcomes (1)
Mortality rate
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Neuroendocrine TumorsStudies 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yupei Zhao, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125929
- Sponsor's protocol ID
- PUMCHGS2013
- Other IDs
- ENRLO
- Status last verified
- Aug 2015
- First submitted
- 26 Apr 2014
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tian F, Hong XF, Wu WM, Han XL, Wang MY, Cong L, Dai MH, Liao Q, Zhang TP, Zhao YP. Propensity score-matched analysis of robotic versus open surgical enucleation for small pancreatic neuroendocrine tumours. Br J Surg. 2016 Sep;103(10):1358-64. doi: 10.1002/bjs.10220. Epub 2016 Aug 2.
PubMed 27480993
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy and Safety Outcomes of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT02125929
- Acronym / sponsor ID
- PUMCHGS2013
- Conditions
- Pancreatic Neuroendocrine Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Apr 2014 (estimated)
- 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.
To determine the efficacy and safety of robotic, laparoscopic and open surgery for enucleation of benign pancreatic neuroendocrine tumors
Detailed description
The study was prospective and retrospective, non-randomized study included patients with benign pancreatic neoplasms. The robotic arm consecutively includes patients underwent robotic enucleation surgery and expected number in this arm is 50. The laparoscopic and open surgery arms retrospectively include case from the year 2004. The number of patients for laparoscopic and open surgery arms are 50 and 100, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| robotic arm | Experimental | Procedure: Robotic surgeryrobotic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50 |
| Laparoscopic surgery | Experimental | Procedure: Laparoscopic surgerylaparoscopic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50 |
| Open surgery | Experimental | Procedure: Open surgeryOpen surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 100 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-80 years old
- Body Mass Index<30
- Preoperative diagnosis of resectable benign Pancreatic Neuroendocrine Tumors
- Tumor type: Non-functional pancreatic endocrine tumours and insulinomas
- largest diameter < 4cm
Key exclusion criteria (4 listed)
- Severe cardio/pulmonary complications
- Other pancreatic diseases, including pancreatitis and pancreatic cancer
- Multiple pancreatic neuroendocrine tumors
- Distant metastasis
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 surgeryRobotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors | Procedure or surgery | robotic arm |
| Laparoscopic surgeryLaparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors | Procedure or surgery | Laparoscopic surgery |
| Open surgeryOpen surgery: enucleation benign Pancreatic Neuroendocrine Tumors | Procedure or surgery | Open surgery |
Primary outcome
Pancreatic fistula rate
Time frame: up to 30 days
1 secondary outcome
Mortality rate
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Derived from this study: PubMed 27480993Tian F, Hong XF, Wu WM, Han XL, Wang MY, Cong L, Dai MH, Liao Q, Zhang TP, Zhao YP. Propensity score-matched analysis of robotic versus open surgical enucleation for small pancreatic neuroendocrine tumours. Br J Surg. 2016 Sep;103(10):1358-64. doi: 10.1002/bjs.10220. Epub 2016 Aug 2.
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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.
Yupei Zhao, MD principal investigator
Peking Union Medical College 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, Laparoscopic surgery and Open surgery in people with Pancreatic Neuroendocrine Tumors, 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 6 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: finished, as of the sponsor's last update on 6 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic fistula rate (time frame: up to 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 NCT02125929, which also lists 1 linked publication.
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 Aug 2015.