Pancreatic CancerPhase 3NCT02514928
Resection of the Nerve Plexus on the Right Half of Celiac and SMA Associated With Extended Pancreatoduodenectomy in the Surgical Treatment for Adenocarcinoma of the Head of Pancreas
A Phase 3 study testing resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy and standard pancreatoduodenectomy in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is performed to confirm whether resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy and standard pancreatoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2019
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed content obtained prior to treatment
- Age ≥ 18 years and ≤ 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- The pathological staging does not exceed the stage IIB
- The expected survival after surgery ≥ 3 months
- Tumor locates at the head of the pancreas without distant metastasis
- No celiac trunk and superior mesenteric artery invasion by Loyer grading
- No operation contraindication
Who cannot join
- The pathological staging exceed the stage IIB
- Pancreatic cancer at the body and tail of the pancreas
- Benign tumor at the head of the pancreas
- Distant metastasis
- Severe important organ function impairment
- Active second primary malignancy or history of second primary malignancy within the last 3 years
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- Pregnant or nursing women
- Human immunodeficiency virus (HIV)-positive patients
- Patients who are unwilling or unable to comply with study procedures
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Pancreatic Cancer Institute
Shanghai, Shanghai Municipality, 200032
Yu Lu, +86 21 64175590 ext. 1305, luyu@fudanpci.org
Xianjun Yu, M.D
About this study
This study is performed to confirm whether resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients.
Read the detailed description
Lymph node metastasis and nerve invasion are characteristics of pancreatic cancer. For pancreatic head cancer, celiac and SMA nerve plexus are often involved. Many surgeons started to improve the surgical approach of pancreatoduodenectomy by extending the extent of surgical resection including an extended lymph node dissection and nerve plexus clearance in the hope of achieving better long-term survival rate. Postoperative complications such as diarrhea and malnutrition were reported after celiac and SMA nerve plexus resection during pancreatoduodenectomy. As a result, resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy was recommended. This study is performed to confirm whether resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients.
Subjects undergoing surgery will be randomized to extended pancreatoduodenectomy with resection of the nerve plexus on the right half of celiac and SMA versus standard pancreatoduodenectomy. Subjects will be followed every two months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of overall survival and the secondary endpoint of disease-specific free survival will be determined at two year post surgery.
- Conditions
- Pancreatic Cancer
- Being tested
- resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy, standard pancreatoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomyProcedure or surgery
Resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy. Regional lymph nodes includes group 5,6,8a,8p,9,12a,12b,12c,12p,13,14a,14b,14c,16,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
standard pancreatoduodenectomyProcedure or surgery
Standard pancreatoduodenectomy with regional lymph nodes includes group 5,6,8a,12b,12c,13,14a,14b,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
| Study group | Role | What they receive |
|---|---|---|
| pancreatoduodenectomy & nerve resection | Experimental | Resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy. Regional lymph nodes includes group 5,6,8a,8p,9,12a,12b,12c,12p,13,14a,14b,14c,16,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS). Receives: Procedure: resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy |
| pancreatoduodenectomy | Active comparator | Standard pancreatoduodenectomy with regional lymph nodes includes group 5,6,8a,12b,12c,13,14a,14b,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS). Receives: Procedure: standard pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years
Secondary outcomes (1)
Pain Control
Pain control will be assess by the Visual Analogue Scale (VAS)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514928
- Sponsor's protocol ID
- PCI003
- Status last verified
- Aug 2016
- First submitted
- 2 Aug 2015
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection of the Nerve Plexus on the Right Half of Celiac and SMA Associated With Extended Pancreatoduodenectomy in the Surgical Treatment for Adenocarcinoma of the Head of Pancreas
- ClinicalTrials.gov ID
- NCT02514928
- Acronym / sponsor ID
- PCI003
- Conditions
- Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 4 Aug 2015 (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.
This study is performed to confirm whether resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients.
Detailed description
Lymph node metastasis and nerve invasion are characteristics of pancreatic cancer. For pancreatic head cancer, celiac and SMA nerve plexus are often involved. Many surgeons started to improve the surgical approach of pancreatoduodenectomy by extending the extent of surgical resection including an extended lymph node dissection and nerve plexus clearance in the hope of achieving better long-term survival rate. Postoperative complications such as diarrhea and malnutrition were reported after celiac and SMA nerve plexus resection during pancreatoduodenectomy. As a result, resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy was recommended. This study is performed to confirm whether resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy could improve survival and relieve pain of pancreatic cancer patients.
Subjects undergoing surgery will be randomized to extended pancreatoduodenectomy with resection of the nerve plexus on the right half of celiac and SMA versus standard pancreatoduodenectomy. Subjects will be followed every two months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of overall survival and the secondary endpoint of disease-specific free survival will be determined at two year post surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pancreatoduodenectomy & nerve resection | Experimental | Procedure: resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomyResection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy. Regional lymph nodes includes group 5,6,8a,8p,9,12a,12b,12c,12p,13,14a,14b,14c,16,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS). |
| pancreatoduodenectomy | Active comparator | Procedure: standard pancreatoduodenectomyStandard pancreatoduodenectomy with regional lymph nodes includes group 5,6,8a,12b,12c,13,14a,14b,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed content obtained prior to treatment
- Age ≥ 18 years and ≤ 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- The pathological staging does not exceed the stage IIB
- The expected survival after surgery ≥ 3 months
Key exclusion criteria (9 listed)
- The pathological staging exceed the stage IIB
- Pancreatic cancer at the body and tail of the pancreas
- Benign tumor at the head of the pancreas
- Distant metastasis
- Severe important organ function impairment
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 |
|---|---|---|
| resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomyResection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy. Regional lymph nodes includes group 5,6,8a,8p,9,12a,12b,12c,12p,13,14a,14b,14c,16,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS). | Procedure or surgery | pancreatoduodenectomy & nerve resection |
| standard pancreatoduodenectomyStandard pancreatoduodenectomy with regional lymph nodes includes group 5,6,8a,12b,12c,13,14a,14b,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS). | Procedure or surgery | pancreatoduodenectomy |
Primary outcome
Overall survival
Time frame: 2 years
1 secondary outcome
Pain Control
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy and standard pancreatoduodenectomy in people with Pancreatic Cancer, run by Fudan University 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 8 inclusion and 9 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 11 Aug 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Xianjun Yu, M.D., Ph.D (+86 21 64175590 ext. 1305, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). 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 11 Aug 2016.