Pancreatic Ductal AdenocarcinomaNCT04115527
Should a Standard Lymphadenectomy Include the No. 16 Lymph Nodes for Patients With Pancreatic Head Adenocarcinoma.
A study testing Extended Lymphadenectomy and Standard Lymphadenectomy in people with Pancreatic Ductal Adenocarcinoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The aim of this study is to determine whether para-aortic lymph nodes(No.16) should be included in the lymphadenectomy during the pancreatoduodenectomy in order to improve the long-term survival of patients with pancreatic head ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Extended Lymphadenectomy and Standard Lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 31 Dec 2023
- 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 70 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 aim of this study is to determine whether para-aortic lymph nodes(No.16) should be included in the lymphadenectomy during the pancreatoduodenectomy in order to improve the long-term survival of patients with pancreatic head ductal adenocarcinoma.
Read the detailed description
Pancreatic cancer is now raised to the 7th leading cause of death. Surgical resection seems to be the unique curative therapy for pancreatic cancer. The pancreaticoduodenectomy is widely performed for the patients with pancreatic head cancer in recent decades. The lymphadenectomy is an indispensible procedure. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) recommended a standard lymphadenectomy should include lymph node stations 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b. However, no consensus was reached on Lymph node 16 in particular 16b1. There was no stronge evidence available concerning the impact on survival.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Extended Lymphadenectomy, Standard Lymphadenectomy
- Keywords
- RCT, Standard lymphadenectomy, Extended lymphadenectomy, Pancreaticoduodenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended LymphadenectomyProcedure or surgery
Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes
Standard LymphadenectomyProcedure or surgery
Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| Standard lymphadenectomy | Active comparator | Standard lymphadenectomy includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes harvested during the pancreaticoduodenectomy with CHILD's digestive reconstruction Receives: Procedure: Standard Lymphadenectomy |
| Extended lymphadenectomy | Experimental | In addition to the standard lymphadenectomy, para-aortic lymph nodes (No16) is included, in particular No 16b1 lymph nodes (Lymph nodes along the psterior side of the pancreas between the aorta and inferior vena cava). Receives: Procedure: Extended Lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year overall survival rate
1 year overall survival rate
Measured: 1 year post-operation
3 years overall survival rate
3 years overall survival rate
Measured: 3 years post-operation
5 years overall survival rate
5 years overall survival rate
Measured: 5 years post-operation
Secondary outcomes (2)
Postoperative Complications
pancreatic fistula, bile leakage, haemorrhage, DGE, etc
Measured: Within 90 days or before discharge
1, 3 & 5 years disease free survival rate
1, 3 \& 5 years disease free survival rate
Measured: 1, 3 & 5 years post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Jun 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weishen WANG, Ruijin Hospital
- Investigators
- Jiancheng WANG, Dr, Study director, Shanghai Ruijin Pancreatic Disease Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115527
- Sponsor's protocol ID
- HBP-RCT-003
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2019
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. 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
- NCT04115527
- Acronym / sponsor ID
- HBP-RCT-003
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- RCT, Standard lymphadenectomy, Extended lymphadenectomy, Pancreaticoduodenectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Oct 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.
The aim of this study is to determine whether para-aortic lymph nodes(No.16) should be included in the lymphadenectomy during the pancreatoduodenectomy in order to improve the long-term survival of patients with pancreatic head ductal adenocarcinoma.
Detailed description
Pancreatic cancer is now raised to the 7th leading cause of death. Surgical resection seems to be the unique curative therapy for pancreatic cancer. The pancreaticoduodenectomy is widely performed for the patients with pancreatic head cancer in recent decades. The lymphadenectomy is an indispensible procedure. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) recommended a standard lymphadenectomy should include lymph node stations 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b. However, no consensus was reached on Lymph node 16 in particular 16b1. There was no stronge evidence available concerning the impact on survival.
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 lymphadenectomy | Active comparator | Procedure: Standard LymphadenectomyStandard lymphadenectomy includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes harvested during the pancreaticoduodenectomy with CHILD's digestive reconstruction |
| Extended lymphadenectomy | Experimental | Procedure: Extended LymphadenectomyIn addition to the standard lymphadenectomy, para-aortic lymph nodes (No16) is included, in particular No 16b1 lymph nodes (Lymph nodes along the psterior side of the pancreas between the aorta and inferior vena cava). |
Who may qualify
- Ages
- 18 to 70 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 |
|---|---|---|
| Extended LymphadenectomyLymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes | Procedure or surgery | Extended lymphadenectomy |
| Standard LymphadenectomyLymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes | Procedure or surgery | Standard lymphadenectomy |
Primary outcome
1 year overall survival rate
Time frame: 1 year post-operation
1 year overall survival rate
3 years overall survival rate
Time frame: 3 years post-operation
3 years overall survival rate
5 years overall survival rate
Time frame: 5 years post-operation
5 years overall survival rate
2 secondary outcomes
Postoperative Complications
Time frame: Within 90 days or before discharge
1, 3 & 5 years disease free survival rate
Time frame: 1, 3 & 5 years post-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- 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.
Jiancheng WANG, Dr 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 Extended Lymphadenectomy and Standard 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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?
1 year overall survival rate (time frame: 1 year post-operation). The study lists 3 primary outcomes in all. 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 17 Oct 2023.