Pancreatic NeoplasmNCT05259384
Robotic Versus Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms
A study testing Robotic pancreaticoduodenectomy, Laparoscopic pancreaticoduodenectomy and Robotic Distal Pancreatectomy in people with Pancreatic Neoplasm, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasm
- What is being tested?
- Robotic pancreaticoduodenectomy, Laparoscopic pancreaticoduodenectomy and Robotic Distal Pancreatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2021to 31 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older;
- Diagnosed as PCN;
- Patients with head or neck PCNs are eligible for minimal invasive PD, or patients with distal PCNs are eligible for minimal invasive DP.
Who cannot join
- Not a PCN base on the sample's pathology;
- Procedure change from MIDP/MIPD to others during the operation;
- ASA more than 4;
- Patients or families deny certain treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Beijing, 100730
Menghua Dai, M.D., daimh@pumch.cn
About this study
Official title: Comparison Between Robotic and Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms
Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Conventionally, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail. In the ear of minimally invasive pancreatic surgery, when compared with open surgery, laparoscopic technology or Da Vinci robotic technology can avoid some open procedures limitations.
Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures.
Read the detailed description
Background: Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. Its heterogeneity is large, which can be benign, borderline, and poor differentiation and even evolve into pancreatic cancer. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Some patients may be accompanied by recurrent pancreatitis, abdominal pain, nausea, vomiting, jaundice, and other gastrointestinal symptoms, usually with the help of abdominal ultrasound and endoscopy, ERCP, CT, nuclear magnetic, or MRCP imaging The examination can diagnose the disease. For PCN patients with large tumors, risk of malignant transformation, and accompanying symptoms that affect the quality of life, surgery is an effective treatment.
Based on the conventional routine treatment, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail.
After more than 20 years of development, minimally invasive pancreatic surgery technology can be divided into two categories: laparoscopic technology and Da Vinci robotic technology. In general, compared with open surgery, minimally invasive pancreatic surgery technology can avoid some open procedures limitations, reduce the loss of intraoperative body fluid and its impact on the internal environment, and avoid excessive disturbance to other abdominal organs. It also helps reduce the pain of patients and shorten the length of hospital stay. Because most PCNs are benign or borderline tumors, such patients are eligible for minimally invasive pancreatic surgery.
Aim and Hypothesis: Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures. We conduct a single-center prospective randomized clinical trial to compare the outcomes of different minimally invasive techniques.
- Conditions
- Pancreatic Neoplasm
- Being tested
- Robotic pancreaticoduodenectomy, Laparoscopic pancreaticoduodenectomy, Robotic Distal Pancreatectomy, Laparoscopic Distal Pancreatectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic pancreaticoduodenectomyProcedure or surgery
The Intervention of MIPD-ROB group
Laparoscopic pancreaticoduodenectomyProcedure or surgery
The Intervention of MIPD-LAP group
Robotic Distal PancreatectomyProcedure or surgery
The Intervention of MIDP-ROB group
Laparoscopic Distal PancreatectomyProcedure or surgery
The Intervention of MIDP-LAP group
| Study group | Role | What they receive |
|---|---|---|
| MIPD-ROB | Experimental | Patients with PCN locates HEAD and NECK of pancreas who were randomized to ROBOTIC pancreaticoduodenectomy. Receives: Procedure: Robotic pancreaticoduodenectomy |
| MIPD-LAP | Active comparator | Patients with PCN locates HEAD and NECK of pancreas who were randomized to LAPAROSCOPIC pancreaticoduodenectomy. Receives: Procedure: Laparoscopic pancreaticoduodenectomy |
| MIDP-ROB | Experimental | Patients with PCN locates BODY and TAIL of pancreas who were randomized to ROBOTIC distal pancreatectomy. Receives: Procedure: Robotic Distal Pancreatectomy |
| MIDP-LAP | Active comparator | Patients with PCN locates BODY and TAIL of pancreas who were randomized to LAPAROSCOPIC distal pancreatectomy. Receives: Procedure: Laparoscopic Distal Pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Rate
The rate of frequency of Clavein-Dindo Grade II-IV complication
Measured: up to 90 days
Secondary outcomes (7)
Postoperative length of stay
The mean of postoperative length of stay
Measured: during the treatment
VAS score
patients complain of pain after surgery, 0-10, 10 means the greatest pain
Measured: up to 90 days
Grade B and C pancreatic fistula
The frequency of grade B or C pancreatic fistula
Measured: up to 90 days
QOL score
Quality of life after surgery, greater means higher life satisfaction
Measured: up to 90 days
Expense
The amount of treatment expense and certain procedure expense
Measured: during the treatment
90-day death rate
The rate of death within 90 days after surgery
Measured: up to 90 days
The rate of spleen-preservation
For DP groups, the rate of spleen being preserved
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start17 Apr 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmStudies 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
- The enrolled candidates will be split into two subgroups(PD group or DP group) based on the location of their neoplasms. Every subgroups will be divided into two parallel groups by the randomization of intervention plan(lap surgery or robotic surgery)
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MENGHUA Dai, M.D., Study chair, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259384
- Sponsor's protocol ID
- Daimh-ROBOTIC-PCN
- Status last verified
- Feb 2022
- First submitted
- 21 Apr 2021
- Last updated
- 28 Feb 2022
- 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 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Robotic and Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms
- ClinicalTrials.gov ID
- NCT05259384
- Acronym / sponsor ID
- Daimh-ROBOTIC-PCN
- Conditions
- Pancreatic Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 17 Apr 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 28 Feb 2022 (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 cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Conventionally, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail. In the ear of minimally invasive pancreatic surgery, when compared with open surgery, laparoscopic technology or Da Vinci robotic technology can avoid some open procedures limitations.
Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures.
Detailed description
Background: Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. Its heterogeneity is large, which can be benign, borderline, and poor differentiation and even evolve into pancreatic cancer. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Some patients may be accompanied by recurrent pancreatitis, abdominal pain, nausea, vomiting, jaundice, and other gastrointestinal symptoms, usually with the help of abdominal ultrasound and endoscopy, ERCP, CT, nuclear magnetic, or MRCP imaging The examination can diagnose the disease. For PCN patients with large tumors, risk of malignant transformation, and accompanying symptoms that affect the quality of life, surgery is an effective treatment.
Based on the conventional routine treatment, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail.
After more than 20 years of development, minimally invasive pancreatic surgery technology can be divided into two categories: laparoscopic technology and Da Vinci robotic technology. In general, compared with open surgery, minimally invasive pancreatic surgery technology can avoid some open procedures limitations, reduce the loss of intraoperative body fluid and its impact on the internal environment, and avoid excessive disturbance to other abdominal organs. It also helps reduce the pain of patients and shorten the length of hospital stay. Because most PCNs are benign or borderline tumors, such patients are eligible for minimally invasive pancreatic surgery.
Aim and Hypothesis: Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures. We conduct a single-center prospective randomized clinical trial to compare the outcomes of different minimally invasive techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The enrolled candidates will be split into two subgroups(PD group or DP group) based on the location of their neoplasms. Every subgroups will be divided into two parallel groups by the randomization of intervention plan(lap surgery or robotic surgery)
| Arm | Type | Receives |
|---|---|---|
| MIPD-ROB | Experimental | Procedure: Robotic pancreaticoduodenectomyPatients with PCN locates HEAD and NECK of pancreas who were randomized to ROBOTIC pancreaticoduodenectomy. |
| MIPD-LAP | Active comparator | Procedure: Laparoscopic pancreaticoduodenectomyPatients with PCN locates HEAD and NECK of pancreas who were randomized to LAPAROSCOPIC pancreaticoduodenectomy. |
| MIDP-ROB | Experimental | Procedure: Robotic Distal PancreatectomyPatients with PCN locates BODY and TAIL of pancreas who were randomized to ROBOTIC distal pancreatectomy. |
| MIDP-LAP | Active comparator | Procedure: Laparoscopic Distal PancreatectomyPatients with PCN locates BODY and TAIL of pancreas who were randomized to LAPAROSCOPIC distal pancreatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or older;
- Diagnosed as PCN;
- Patients with head or neck PCNs are eligible for minimal invasive PD, or patients with distal PCNs are eligible for minimal invasive DP.
Key exclusion criteria (4 listed)
- Not a PCN base on the sample's pathology;
- Procedure change from MIDP/MIPD to others during the operation;
- ASA more than 4;
- Patients or families deny certain treatment.
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 pancreaticoduodenectomyThe Intervention of MIPD-ROB group | Procedure or surgery | MIPD-ROB |
| Laparoscopic pancreaticoduodenectomyThe Intervention of MIPD-LAP group | Procedure or surgery | MIPD-LAP |
| Robotic Distal PancreatectomyThe Intervention of MIDP-ROB group | Procedure or surgery | MIDP-ROB |
| Laparoscopic Distal PancreatectomyThe Intervention of MIDP-LAP group | Procedure or surgery | MIDP-LAP |
Primary outcome
Complication Rate
Time frame: up to 90 days
The rate of frequency of Clavein-Dindo Grade II-IV complication
7 secondary outcomes
Postoperative length of stay
Time frame: during the treatment
VAS score
Time frame: up to 90 days
Grade B and C pancreatic fistula
Time frame: up to 90 days
QOL score
Time frame: up to 90 days
Expense
Time frame: during the treatment
90-day death rate
Time frame: up to 90 days
The rate of spleen-preservation
Time frame: up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- 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, M.D. study chair
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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 pancreaticoduodenectomy, Laparoscopic pancreaticoduodenectomy and Robotic Distal Pancreatectomy in people with Pancreatic Neoplasm, 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 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: status not confirmed, as of the sponsor's last update on 28 Feb 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. 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 Hanyu Zhang, M.D. (01069152600, medzhy5813@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Rate (time frame: up to 90 days). 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 28 Feb 2022.