Periampullary TumorNCT04037982
RCT Study on Safety of LPD and OPD in the Treatment of Periampullary Tumors
A study testing laparoscopic pancreaticoduodenectomy and Open pancreaticoduodenectomy in people with Periampullary Tumor and Complication, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Pancreaticoduodenectomy (PD) is considered one of the most complex and dangerous procedures in general surgery. This procedure is the preferred surgical procedure for treating tumors around the ampulla. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Periampullary Tumor, Complication, Death
- What is being tested?
- laparoscopic pancreaticoduodenectomy and Open pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- Aug 2019to Dec 2022
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Preoperative imaging diagnosis of periampullary tumor, or preoperative pathological diagnosis of periampullary tumor, preoperative evaluation can be performed pancreaticoduodenectomy; Serum bilirubin was less than 100 μ mol/L before operation; Sign a written informed consent form and agree to be randomly divided into groups for surgical treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital medical University
Beijing
Wei Guo
About this study
Official title: A Randomized Controlled Study on the Safety of Total Laparoscopy and Traditional Open Pancreaticoduodenectomy in the Treatment of Periampullary Tumors
Pancreaticoduodenectomy (PD) is considered one of the most complex and dangerous procedures in general surgery. This procedure is the preferred surgical procedure for treating tumors around the ampulla. Traditional open pancreaticoduodenectomy (OPD) has brought great surgical trauma to patients while treating diseases. In 1994, Gagner et al first reported laparoscopic pancreaticoduodenectomy (LPD). With the development of laparoscopic techniques, the updating of devices, and the continuous accumulation of laparoscopic gastrointestinal surgery experience, the results of retrospective studies published show that there is no significant difference in safety between LPD and OPD. However, the results of the recently published RCT study show that the mortality associated with LPD complications is five times greater than that of OPD. At present, the security of LPD has been controversial. Therefore we conducted a prospective randomized controlled trial with a primary outcome of perioperative complications, providing evidence-based results for the safe and effective clinical development of LPD.
- Conditions
- Periampullary Tumor, Complication, Death, Survival
- Being tested
- laparoscopic pancreaticoduodenectomy, Open pancreaticoduodenectomy
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic pancreaticoduodenectomyProcedure or surgery
During laparoscopic surgery, the surgeon makes several smaller incisions in your abdomen and inserts special instruments, including a camera that transmits video to a monitor in the operating room. The surgeon watches the monitor to guide the surgical tools in performing the Whipple procedure. Laparoscopic surgery is a type of minimally invasive surgery.
Open pancreaticoduodenectomyProcedure or surgery
During an open procedure, your surgeon makes an incision in your abdomen in order to access your pancreas. This is the most common approach and the most studied.
| Study group | Role | What they receive |
|---|---|---|
| LPD | Experimental | In this group, patients will undergo laparoscopic pancreaticoduodenectomy. Receives: Procedure: laparoscopic pancreaticoduodenectomy |
| OPD | Active comparator | In this group, patients will undergo open pancreaticoduodenectomy. Receives: Procedure: Open pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
The patients number with complications / The total number in this group
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periampullary TumorStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037982
- Sponsor's protocol ID
- CR-LPD
- Status last verified
- Jul 2019
- First submitted
- 28 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Safety of Total Laparoscopy and Traditional Open Pancreaticoduodenectomy in the Treatment of Periampullary Tumors
- ClinicalTrials.gov ID
- NCT04037982
- Acronym / sponsor ID
- CR-LPD
- Conditions
- Periampullary Tumor, Complication, Death, Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Jul 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.
Pancreaticoduodenectomy (PD) is considered one of the most complex and dangerous procedures in general surgery. This procedure is the preferred surgical procedure for treating tumors around the ampulla. Traditional open pancreaticoduodenectomy (OPD) has brought great surgical trauma to patients while treating diseases. In 1994, Gagner et al first reported laparoscopic pancreaticoduodenectomy (LPD). With the development of laparoscopic techniques, the updating of devices, and the continuous accumulation of laparoscopic gastrointestinal surgery experience, the results of retrospective studies published show that there is no significant difference in safety between LPD and OPD. However, the results of the recently published RCT study show that the mortality associated with LPD complications is five times greater than that of OPD. At present, the security of LPD has been controversial. Therefore we conducted a prospective randomized controlled trial with a primary outcome of perioperative complications, providing evidence-based results for the safe and effective clinical development of LPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPD | Experimental | Procedure: laparoscopic pancreaticoduodenectomyIn this group, patients will undergo laparoscopic pancreaticoduodenectomy. |
| OPD | Active comparator | Procedure: Open pancreaticoduodenectomyIn this group, patients will undergo open pancreaticoduodenectomy. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 pancreaticoduodenectomyDuring laparoscopic surgery, the surgeon makes several smaller incisions in your abdomen and inserts special instruments, including a camera that transmits video to a monitor in the operating room. The surgeon watches the monitor to guide the surgical tools in performing the Whipple procedure. Laparoscopic surgery is a type of minimally invasive surgery. | Procedure or surgery | LPD |
| Open pancreaticoduodenectomyDuring an open procedure, your surgeon makes an incision in your abdomen in order to access your pancreas. This is the most common approach and the most studied. | Procedure or surgery | OPD |
Primary outcome
Incidence of complications
Time frame: 30 days after operation
The patients number with complications / The total number in this group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic pancreaticoduodenectomy and Open pancreaticoduodenectomy in people with Periampullary Tumor and Complication, run by Beijing Friendship 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?
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 30 Jul 2019. 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?
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?
Incidence of complications (time frame: 30 days after operation). 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 Jul 2019.