Pancreatic Ductal AdenocarcinomaNCT02787187
Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?
A study testing Pancreaticoduodenectomy with Standard lymphadenectomy and Pancreaticoduodenectomy with Extended lymphadenectomy in people with Pancreatic Ductal Adenocarcinoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare outcomes of patients undergoing standard or extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Pancreaticoduodenectomy with Standard lymphadenectomy and Pancreaticoduodenectomy with Extended lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to Oct 2021
- 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
- Pathologic diagnosis of pancreatic ductal adenocarcinoma
- Signed the informed consents
Who cannot join
- Pathologic diagnosis of other pancreatic cancers
- Pre-operative anti-cancer treatment
- Recurrence patients
- Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
- Pre operative exam: Total bilirubin more than 250µmol/L
- AJCC stage IV
- Operation non radical
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer
The purpose of this study is to compare outcomes of patients undergoing standard or extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Pancreaticoduodenectomy with Standard lymphadenectomy, Pancreaticoduodenectomy with Extended lymphadenectomy
- Keywords
- Standard lymphadenectomy, extended lymphadenectomy, pancreaticoduodenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreaticoduodenectomy with Standard lymphadenectomyProcedure or surgery
Pancreaticoduodenectomy：child's digestive reconstruction standard lymphadenectomy: No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b
Pancreaticoduodenectomy with Extended lymphadenectomyProcedure or surgery
Pancreaticoduodenectomy：child's digestive reconstruction extended lymphadenectomy: No8p 12a 12p 14c 14d 16
| Study group | Role | What they receive |
|---|---|---|
| Standard resection | Active comparator | Pancreaticoduodenectomy (child's digestive reconstruction); Standard lymphadenectomy: No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b Receives: Procedure: Pancreaticoduodenectomy with Standard lymphadenectomy |
| Extended resection | Experimental | Pancreaticoduodenectomy (child's digestive reconstruction)extended lymphadenectomy No8p 12a 12p 14c 14d 16 Receives: Procedure: Pancreaticoduodenectomy with Extended lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 3yrs post-operation
Secondary outcomes (1)
all-cause mortality
Measured: 1yr post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start1 Jul 2016
- Primary completionOct 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Weishen WANG, Ruijin Hospital
- Investigators
- Baiyong SHEN, Study director, Shanghai Ruijin Pancreatic Disease Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787187
- Sponsor's protocol ID
- HBP-RCT-001
- Status last verified
- Nov 2021
- First submitted
- 23 May 2016
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer
- ClinicalTrials.gov ID
- NCT02787187
- Acronym / sponsor ID
- HBP-RCT-001
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Standard lymphadenectomy, extended lymphadenectomy, pancreaticoduodenectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 1 Jun 2016 (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.
The purpose of this study is to compare outcomes of patients undergoing standard or extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard resection | Active comparator | Procedure: Pancreaticoduodenectomy with Standard lymphadenectomyPancreaticoduodenectomy (child's digestive reconstruction); Standard lymphadenectomy: No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b |
| Extended resection | Experimental | Procedure: Pancreaticoduodenectomy with Extended lymphadenectomyPancreaticoduodenectomy (child's digestive reconstruction)extended lymphadenectomy No8p 12a 12p 14c 14d 16 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pathologic diagnosis of pancreatic ductal adenocarcinoma
- Signed the informed consents
Key exclusion criteria (7 listed)
- Pathologic diagnosis of other pancreatic cancers
- Pre-operative anti-cancer treatment
- Recurrence patients
- Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
- Pre operative exam: Total bilirubin more than 250µmol/L
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 |
|---|---|---|
| Pancreaticoduodenectomy with Standard lymphadenectomyPancreaticoduodenectomy：child's digestive reconstruction standard lymphadenectomy: No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b | Procedure or surgery | Standard resection |
| Pancreaticoduodenectomy with Extended lymphadenectomyPancreaticoduodenectomy：child's digestive reconstruction extended lymphadenectomy: No8p 12a 12p 14c 14d 16 | Procedure or surgery | Extended resection |
Primary outcome
All-cause mortality
Time frame: 3yrs post-operation
1 secondary outcome
all-cause mortality
Time frame: 1yr post-operation
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 23 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Baiyong SHEN study director
Shanghai Ruijin Pancreatic Disease Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pancreaticoduodenectomy with Standard lymphadenectomy and Pancreaticoduodenectomy with Extended lymphadenectomy in people with Pancreatic Ductal Adenocarcinoma, run by Ruijin 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 2 inclusion and 7 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 23 Nov 2021. 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?
All-cause mortality (time frame: 3yrs post-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 23 Nov 2021.