Periampullary AdenocarcinomaNPPCNCT05788029
Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
A study testing laparoscopic pancreaticoduodenectomy and open pancreaticoduodenectomy in people with Periampullary Adenocarcinoma, run by Tongji Hospital at 1 site in China.
Trial summary
The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Periampullary Adenocarcinoma
- 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
- 212 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age between 18 years and 75 years.
- Histologically confirmed NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence.
- Patients feasible to undergo both LPD and OPD ac- cording to MDT evaluations.
- Patients understanding and willing to comply with this trial.
- Provision of written informed consent before patient registration.
- Patients meeting the curative treatment intent in ac- cordance with clinical guidelines.
Who cannot join
- Patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs.
- Patients requiring left, central or total pancreatecto- my or other palliative surgery.
- Preoperative American Society of Anaesthesiologists (ASA) score ≥4.
- History of other malignant disease
- Pregnant or breastfeeding women.
- Patients with serious mental disorders
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- Patients treated with neoadjuvant therapy.
- Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
- Body mass index >35 kg/m 2 .
- Patients participating in any other clinical trials with- in 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma
Read the detailed description
The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma
- Conditions
- Periampullary Adenocarcinoma
- Being tested
- laparoscopic pancreaticoduodenectomy, open pancreaticoduodenectomy
- Keywords
- non-pancreatic periampullary adenocarcinoma, laparoscopic pancreaticoduodenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic pancreaticoduodenectomyProcedure or surgery
laparoscopic pancreaticoduodenectomy
open pancreaticoduodenectomyProcedure or surgery
open pancreaticoduodenectomy
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic pancreaticoduodenectomy | Experimental | laparoscopic pancreaticoduodenectomy Receives: Procedure: laparoscopic pancreaticoduodenectomy |
| open pancreaticoduodenectomy | Active comparator | open pancreaticoduodenectomy Receives: Procedure: open pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay
defined as the number of nights spent in the hospital from the end of the surgical procedure until discharge or death
Measured: 90 days
Secondary outcomes (10)
1 year OS
1 year OS
Measured: 1 year
Operative time
Total duration of the surgical procedure(minutes)
Measured: From enrollment to the end of operation
Estimated blood loss
Intraoperative estimated blood loss volume(ml).
Measured: From enrollment to the end of operation
Intraoperative transfusion volume
Volume of blood products transfused during the operation(ml)
Measured: From enrollment to the end of operation
perioperative complication rate
proportion of patients experiencing postoperative complications)
Measured: 90 days
mortality rate and unplanned readmission rate
percentage of patients who die or require unplanned readmission within 90 days post-operation
Measured: 90 days
Karnofsky Performance Status (KPS) score
Functional status assessment. Scores range from 0 to 100, with higher scores indicating better functional status.
Unit of Measure: score (0-100)
Measured: Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively
Eastern Cooperative Oncology Group (ECOG) performance status score
Functional status assessment. Scores range from 0 to 5, with lower scores indicating better functional status.
Unit of Measure: score (0-5)
Measured: Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively
Surgical costs
Direct costs of the surgical procedure itself, including operating room fees, anesthesia fees, surgical supplies, and intraoperative medications.
Unit of Measure: CNY
Measured: perioperatively
Total hospitalization expenses
Total inpatient costs from admission to discharge, including surgical costs, medications, bed charges, laboratory tests, imaging, nursing care, and other hospital services.
Unit of Measure: CNY
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Jan 2024
- Primary completion31 Aug 2026 (estimated)
- Study completionDec 2028 (estimated)
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 Periampullary AdenocarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, The First Affiliated Hospital of Dalian Medical University, The Affiliated Hospital of Xuzhou Medical University, The Third Affiliated Hospital of Soochow University, Shanxi Province Cancer Hospital, Army Medical University, China, Qilu Hospital of Shandong University, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of University of South China, First Affiliated Hospital of Harbin Medical University, Chongqing General Hospital, Tianjin Medical University Cancer Institute and Hospital
- Responsible party
- Principal investigator, Renyi Qin, Tongji Hospital
- Investigators
- Renyi Qin, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788029
- Sponsor's protocol ID
- TJDBPS14
- Other IDs
- TJDBPS14
- Acronym
- NPPC
- Status last verified
- May 2026
- First submitted
- 30 Nov 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical restrictions approved by the ethics committees of all participating centres. The participant consent form did not include provisions for data sharing beyond the primary research team. The study protocol and statistical analysis plan are available as supplementary materials.
Publications
Li S, Pan S, Wang M, Huang X, Zhao W, Yu X, Chen X, Chen H, Dang X, Chen G, Wang L, An W, Zhang Q, Gao S, Guo S, Qin T, Zhang H, Qin R. Laparoscopic versus open pancreaticoduodenectomy for non-pancreatic periampullary adenocarcinomas: study protocol for a multicentre randomised controlled trial in China. BMJ Open. 2026 Jul 6;16(7):e117495. doi: 10.1136/bmjopen-2026-117495.
PubMed 42409398
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Laparoscopic and Open Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
- ClinicalTrials.gov ID
- NCT05788029
- Acronym / sponsor ID
- NPPC / TJDBPS14
- Conditions
- Periampullary Adenocarcinoma
- Keywords
- non-pancreatic periampullary adenocarcinoma, laparoscopic pancreaticoduodenectomy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Fudan University, The First Affiliated Hospital of Dalian Medical University, The Affiliated Hospital of Xuzhou Medical University, The Third Affiliated Hospital of Soochow University, Shanxi Province Cancer Hospital, Army Medical University, China, Qilu Hospital of Shandong University, Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of University of South China, First Affiliated Hospital of Harbin Medical University, Chongqing General Hospital, Tianjin Medical University Cancer Institute and Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Mar 2023 (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 aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma
Detailed description
The aim of this study was to evaluate the outcomes of LPD versus OPD in non-pancreatic periampullary adenocarcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic pancreaticoduodenectomy | Experimental | Procedure: laparoscopic pancreaticoduodenectomylaparoscopic pancreaticoduodenectomy |
| open pancreaticoduodenectomy | Active comparator | Procedure: open pancreaticoduodenectomyopen pancreaticoduodenectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 years and 75 years.
- Histologically confirmed NPPC or clinically diagnosed NPPC by an MDT without histopathologic evidence.
- Patients feasible to undergo both LPD and OPD ac- cording to MDT evaluations.
- Patients understanding and willing to comply with this trial.
- Provision of written informed consent before patient registration.
Key exclusion criteria (10 listed)
- Patients with distant metastases, including peritone- al, liver, distant lymph node metastases and involve- ment of other organs.
- Patients requiring left, central or total pancreatecto- my or other palliative surgery.
- Preoperative American Society of Anaesthesiologists (ASA) score ≥4.
- History of other malignant disease
- Pregnant or breastfeeding women.
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 pancreaticoduodenectomylaparoscopic pancreaticoduodenectomy | Procedure or surgery | laparoscopic pancreaticoduodenectomy |
| open pancreaticoduodenectomyopen pancreaticoduodenectomy | Procedure or surgery | open pancreaticoduodenectomy |
Primary outcome
length of hospital stay
Time frame: 90 days
defined as the number of nights spent in the hospital from the end of the surgical procedure until discharge or death
10 secondary outcomes
1 year OS
Time frame: 1 year
Operative time
Time frame: From enrollment to the end of operation
Estimated blood loss
Time frame: From enrollment to the end of operation
Intraoperative transfusion volume
Time frame: From enrollment to the end of operation
perioperative complication rate
Time frame: 90 days
mortality rate and unplanned readmission rate
Time frame: 90 days
Karnofsky Performance Status (KPS) score
Time frame: Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively
Eastern Cooperative Oncology Group (ECOG) performance status score
Time frame: Preoperatively, at discharge(at hospital discharge, assessed up to 30 days postoperatively), and at 6 months postoperatively
Surgical costs
Time frame: perioperatively
Total hospitalization expenses
Time frame: perioperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 42409398Li S, Pan S, Wang M, Huang X, Zhao W, Yu X, Chen X, Chen H, Dang X, Chen G, Wang L, An W, Zhang Q, Gao S, Guo S, Qin T, Zhang H, Qin R. Laparoscopic versus open pancreaticoduodenectomy for non-pancreatic periampullary adenocarcinomas: study protocol for a multicentre randomised controlled trial in China. BMJ Open. 2026 Jul 6;16(7):e117495. doi: 10.1136/bmjopen-2026-117495.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical restrictions approved by the ethics committees of all participating centres. The participant consent form did not include provisions for data sharing beyond the primary research team. The study protocol and statistical analysis plan are available as supplementary materials.
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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.
Renyi Qin principal investigator
Tongji 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 laparoscopic pancreaticoduodenectomy and open pancreaticoduodenectomy in people with Periampullary Adenocarcinoma, run by Tongji 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 10 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: enrolling by invitation, as of the sponsor's last update on 18 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
length of hospital stay (time frame: 90 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 NCT05788029, 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 18 May 2026.