Resectable Lesions Located in the Pancreatic Head or Periampullary RegionNCT05520606
Laparoscopic Pancreatoduodenectomy Versus Open Pancreatoduodenectomy
An observational study of Resectable Lesions Located in the Pancreatic Head or Periampullary Region, run by Tongji Hospital.
Trial summary
This is a single, retrospective, real-world study to investigate the surgical outcomes of minimally invasive pancreatoduodenectomy and open pancreatoduodenectomy, with the perioperative characteristics and long-term overall survival being compared. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Resectable Lesions Located in the Pancreatic Head or Periampullary Region
- What is being tested?
- pancreatoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Dec 2021
- Phase
- Observational
- 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
Study population: Patients who underwent PD surgeries in Tongji Hospital since January 2014 .
Who may be able to join
- Aged 18 to 80 years.
- Patients underwent PD surgeries.
Who cannot join
- Peritoneal seeding or metastasis to distant sites;
- Incomplete clinical data.
About this study
Official title: Minimally Invasive Versus Open for Pancreatoduodenectomy：an Retrospective, Observational, Multicenter Real-world Study
This is a single, retrospective, real-world study to investigate the surgical outcomes of minimally invasive pancreatoduodenectomy and open pancreatoduodenectomy, with the perioperative characteristics and long-term overall survival being compared. The investigators aimed to find out whether the minimally invasive surgery is safe and feasible for resectable lesions located in the pancreatic head and periampullary region. And the investigators also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.
Read the detailed description
Pancreatoduodenectomy (Whipple surgery) is a complex surgical procedure and has been accepted as the gold standard treatment for resectable lesions of the pancreatic head and periampullary region.To date, how surgeons can safely pass the learning curve of laparoscopic pancreatoduodenectomy (LPD) without potentially harming patients remains a question. Around this topic, the investigators designed real-world study in a single center to retrospectively collect the PD surgeries since July 2014. The investigators aimed to find out whether the minimally invasive surgery is safe and feasible for resectable lesions located in the pancreatic head and periampullary region. And the investigators also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach. Besides, the investigators also want to investigate the clinical characteristics of patients and perioperative outcomes of LPD procedures and aimed to develop and validate a difficulty scoring system for patient selection which could help facilitate a comprehensive and security understanding of LPD for surgeon during different stage of the learning curve.
- Being tested
- pancreatoduodenectomy
- Keywords
- laparoscopic, minimally invasive, open resection, Pancreatoduodenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatoduodenectomyProcedure or surgery
Pancreatoduodenectomy (Whipple surgery) is a complex surgical procedure and has been accepted as the gold standard treatment for resectable lesions of the pancreatic head and periampullary region
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive surgery | laparoscopic pancreatoduodenectomy. Receives: Procedure: pancreatoduodenectomy | |
| open surgery | open pancreatoduodenectomy Receives: Procedure: pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative length of stay
defined as the time from being admitted to hospital to discharge
Measured: up to 90 days
Secondary outcomes (8)
Overall survival
defined as the duration from the first day after surgery to either the date of death or the last follow-up
Measured: through study completion, an average of 5 year
Operation time
defined as the time from skin incision or trocar placement to complete skin closure
Measured: intraoperative
postoperative complications
Postoperative complications were reviewed within 90 days after surgery and graded according to Clavien-Dindo (CD) classification system. Postoperative biliary leakage, hemorrhage, and liver failure. Wound infection was defined as purulent drainage from the incision or/and positive findings of culture of the fluid or tissue aseptically obtained from the incision.
Measured: up to 90 days
Reoperation within 90 days
defined as any reoperation within 90 days
Measured: up to 90 days
Mortality
defined as any death within 30 days and 90 days, respectively
Measured: up to 90 days
Readmission within 90 days
defined as any readmission within 90 days
Measured: up to 90 days
R0 resection
defined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins
Measured: intraoperative
Intraoperative blood loss
recorded by the anesthetist using a vacuum system
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Jan 2014
- Primary completion30 Dec 2019
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Lesions Located in the Pancreatic Head or Periampullary RegionStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renyi Qin, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520606
- Sponsor's protocol ID
- TJDBPS11
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 30 Aug 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 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Versus Open for Pancreatoduodenectomy：an Retrospective, Observational, Multicenter Real-world Study
- ClinicalTrials.gov ID
- NCT05520606
- Acronym / sponsor ID
- TJDBPS11
- Keywords
- laparoscopic, minimally invasive, open resection, Pancreatoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 30 Aug 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.
This is a single, retrospective, real-world study to investigate the surgical outcomes of minimally invasive pancreatoduodenectomy and open pancreatoduodenectomy, with the perioperative characteristics and long-term overall survival being compared. The investigators aimed to find out whether the minimally invasive surgery is safe and feasible for resectable lesions located in the pancreatic head and periampullary region. And the investigators also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.
Detailed description
Pancreatoduodenectomy (Whipple surgery) is a complex surgical procedure and has been accepted as the gold standard treatment for resectable lesions of the pancreatic head and periampullary region.To date, how surgeons can safely pass the learning curve of laparoscopic pancreatoduodenectomy (LPD) without potentially harming patients remains a question. Around this topic, the investigators designed real-world study in a single center to retrospectively collect the PD surgeries since July 2014. The investigators aimed to find out whether the minimally invasive surgery is safe and feasible for resectable lesions located in the pancreatic head and periampullary region. And the investigators also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach. Besides, the investigators also want to investigate the clinical characteristics of patients and perioperative outcomes of LPD procedures and aimed to develop and validate a difficulty scoring system for patient selection which could help facilitate a comprehensive and security understanding of LPD for surgeon during different stage of the learning curve.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive surgery | – | Procedure: pancreatoduodenectomylaparoscopic pancreatoduodenectomy. |
| open surgery | – | Procedure: pancreatoduodenectomyopen pancreatoduodenectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent PD surgeries in Tongji Hospital since January 2014 .
Key inclusion criteria (2 listed)
- Aged 18 to 80 years.
- Patients underwent PD surgeries.
Key exclusion criteria (2 listed)
- Peritoneal seeding or metastasis to distant sites;
- Incomplete clinical data.
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 |
|---|---|---|
| pancreatoduodenectomyPancreatoduodenectomy (Whipple surgery) is a complex surgical procedure and has been accepted as the gold standard treatment for resectable lesions of the pancreatic head and periampullary region | Procedure or surgery | minimally invasive surgery, open surgery |
Primary outcome
Postoperative length of stay
Time frame: up to 90 days
defined as the time from being admitted to hospital to discharge
8 secondary outcomes
Overall survival
Time frame: through study completion, an average of 5 year
Operation time
Time frame: intraoperative
postoperative complications
Time frame: up to 90 days
Reoperation within 90 days
Time frame: up to 90 days
Mortality
Time frame: up to 90 days
Readmission within 90 days
Time frame: up to 90 days
R0 resection
Time frame: intraoperative
Intraoperative blood loss
Time frame: intraoperative
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 30 Aug 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Lesions Located in the Pancreatic Head or Periampullary Region, run by Tongji Hospital.
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 2 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 30 Aug 2022. 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?
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?
Postoperative length of stay (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 30 Aug 2022.