Cancer of PancreasNCT03659292
Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy
A study testing GEA, PCEA and GA in people with Cancer of Pancreas, run by Fudan University at 3 sites in China.
Trial summary
The purpose of this randomized controlled clinical trial is to investigate the effects of epidural block on overall survival，disease-free survival and recovery in patients with pancreatic cancer undergoing distal pancreatectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer of Pancreas
- What is being tested?
- GEA, PCEA and GA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 3 sitesChina
- Study dates
- Sep 2018to Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective distal pancreatectomy for pancreatic cancer .
- ASA statusⅠ-Ⅲ.
- 18 years to 80 years （adults）.
- Able to understand, communicate and sign an informed consent form.
Who cannot join
- Laparoscopic surgery.
- Preoperative chemotherapy or radiotherapy.
- Pregnancy.
- Allergic to any drugs used during the study.
- Long-term receiving β-blockers.
- Complicated with chronic inflammatory diseases, autoimmune diseases, or long-term receiving glucocorticoids or other immunosuppressants before surgery.
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- Abnormal coagulation functions (platelet count prior to surgery <100000/ μL , APTT value is more than the normal value, INR > 1.3 or clopidogrel that cannot be discontinued 7 days prior to surgery).
- Complicated with severe heart disease (NYHA classification >3), severe renal insufficiency (serum creatinine >1.8mg/dL or receiving renal replacement therapy), severe hepatic disease (Child-Pugh classification=C), diabetes (fasting blood glucose not in the range of 3.9-13.8 mmol/L ), or acute infectious diseases (WBC>10000/μL) before surgery.
- BMI > 35.
- All contraindications to epidural block.
- Chronic opiate medication/drug abuse.
- Complicated with severe mental illness, cognitive disorder or unable to collaborate during the study.
- Refuse to sign an informed consent form.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Changhong Miao, +86-021-64175590 ext. 82420, miaochh@aliyun.com
Xuqin Zhu, +86-021-64175590 ext. 82420, zhuxuqin1101@sina.com
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Jing Cang, +86-139-1601-0421, cangjing1998@aliyun.com
Fudan University Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Yingwei Wang, +86-139-1869-0528, wangyingwei@yahoo.com
About this study
Official title: Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy----A Multi-center Randomized Controlled Trial
The purpose of this randomized controlled clinical trial is to investigate the effects of epidural block on overall survival，disease-free survival and recovery in patients with pancreatic cancer undergoing distal pancreatectomy. This study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.
- Conditions
- Cancer of Pancreas
- Being tested
- GEA, PCEA, GA, PCIA
- Keywords
- Epidural block, Pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEAOther
Also called General anesthesia combined with epidural anesthesia
Thoracic epidural catheterization will be performed and epidural anesthesia will be maintained with 0.25% ropivacaine during surgery. General anesthesia will be maintained with inhalation (sevoflurane) and muscle relaxants will be administered when considered necessary.
PCEAOther
Also called Patient-controlled epidural analgesia
Patient-controlled epidural analgesia (0.15% ropivacaine and 0.5ug/ml sufentanil infusion) will be provided after surgery.
GAOther
Also called General anesthesia
General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
PCIAOther
Also called Patient-controlled intravenous analgesia
Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
| Study group | Role | What they receive |
|---|---|---|
| GEA+PCEA | Experimental | General anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery. Receives: Other: GEA; Other: PCEA |
| GA+PCIA | Other | General anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery. Receives: Other: GA; Other: PCIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Defined and calculated as the time from the date of surgery to death related to all reasons
Measured: During 2 years after surgery
Secondary outcomes (12)
Disease-free survival (DFS )
Defined and calculated as the time from the date of surgery to the first time of pancreatic cancer recurrence or metastasis or cancer-related death
Measured: During 2 years after surgery
Postoperative pain score and side effects of patient-controlled analgesia
Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
Measured: During the first 48 hours after surgery
Incidence of delirium
Assessed for delirium using the 3D-CAM instrument
Measured: During the first 1 week after surgery
Incidence of persistent post-surgical pain (PPSP) after surgery
Assessed with visual analogue score ( 0 is no pain and 10 is the most severe pain)
Measured: During 2 years after surgery
Length of stay in hospital after surgery
Measured: During the first 30 days after surgery
Return of bowel function
Measured by the time of first flatus
Measured: During the first 30 days after surgery
Removal of Perianastomotic drains
Measured: During the first 30 days after surgery
Removal of Urinary drainage
Measured: During the first 30 days after surgery
Removal of nasogastric tube
Measured: During the first 30 days after surgery
Blood level of neuroendocrine, stress and inflammatory response
Changes of blood epinephrine, norepinephrine, cortisol, VEGF, interleukin-6 (IL-6)、interleukin-8 (IL-8), peripheral blood NLR ( neutrophil-lymphocyte ratio)
Measured: During surgery and the first 24 hours after surgery
Blood CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels
Measured: During 2 years after surgery
Blood levels of ropivacaine and sufentanil
Measured: During surgery and the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study startSep 2018 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, Changhong Miao, Fudan University
- Investigators
- Changhong Miao, Principal investigator, Fudan UniversityQianjin Liu, Study director, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659292
- Sponsor's protocol ID
- FDUSCCA-2
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy----A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03659292
- Acronym / sponsor ID
- FDUSCCA-2
- Conditions
- Cancer of Pancreas
- Keywords
- Epidural block, Pancreatic cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- Sep 2018 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 6 Sep 2018 (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 purpose of this randomized controlled clinical trial is to investigate the effects of epidural block on overall survival，disease-free survival and recovery in patients with pancreatic cancer undergoing distal pancreatectomy. This study will also evaluate the effects of this technique on neuroendocrine, stress and inflammatory response in these patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GEA+PCEA | Experimental | Other: GEA, Other: PCEAGeneral anesthesia combined with epidural anesthesia will be performed during surgery and patient-controlled epidural analgesia (PCEA) will be provided after surgery. |
| GA+PCIA | Other | Other: GA, Other: PCIAGeneral anesthesia will be performed during surgery and patient-controlled intravenous analgesia (PCIA) will be provided after surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing elective distal pancreatectomy for pancreatic cancer .
- ASA statusⅠ-Ⅲ.
- 18 years to 80 years （adults）.
- Able to understand, communicate and sign an informed consent form.
Key exclusion criteria (13 listed)
- Laparoscopic surgery.
- Preoperative chemotherapy or radiotherapy.
- Pregnancy.
- Allergic to any drugs used during the study.
- Long-term receiving β-blockers.
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 |
|---|---|---|
| GEAAlso: General anesthesia combined with epidural anesthesiaThoracic epidural catheterization will be performed and epidural anesthesia will be maintained with 0.25% ropivacaine during surgery. General anesthesia will be maintained with inhalation (sevoflurane) and muscle relaxants will be administered when considered necessary. | Other | GEA+PCEA |
| PCEAAlso: Patient-controlled epidural analgesiaPatient-controlled epidural analgesia (0.15% ropivacaine and 0.5ug/ml sufentanil infusion) will be provided after surgery. | Other | GEA+PCEA |
| GAAlso: General anesthesiaGeneral anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary. | Other | GA+PCIA |
| PCIAAlso: Patient-controlled intravenous analgesiaPatient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery. | Other | GA+PCIA |
Primary outcome
Overall survival (OS)
Time frame: During 2 years after surgery
Defined and calculated as the time from the date of surgery to death related to all reasons
12 secondary outcomes
Disease-free survival (DFS )
Time frame: During 2 years after surgery
Postoperative pain score and side effects of patient-controlled analgesia
Time frame: During the first 48 hours after surgery
Incidence of delirium
Time frame: During the first 1 week after surgery
Incidence of persistent post-surgical pain (PPSP) after surgery
Time frame: During 2 years after surgery
Length of stay in hospital after surgery
Time frame: During the first 30 days after surgery
Return of bowel function
Time frame: During the first 30 days after surgery
Removal of Perianastomotic drains
Time frame: During the first 30 days after surgery
Removal of Urinary drainage
Time frame: During the first 30 days after surgery
Removal of nasogastric tube
Time frame: During the first 30 days after surgery
Blood level of neuroendocrine, stress and inflammatory response
Time frame: During surgery and the first 24 hours after surgery
Blood CA19-9 、CA125、CEA、CA72-4、CA242、AFP、CA15-3、CA50 levels
Time frame: During 2 years after surgery
Blood levels of ropivacaine and sufentanil
Time frame: During surgery and the first 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Changhong Miao principal investigator
Fudan University
Qianjin Liu study director
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GEA, PCEA and GA in people with Cancer of Pancreas, run by Fudan University at 3 sites 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 4 inclusion and 13 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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Changhong Miao (+86-021-64175590 ext. 82420, miaochh@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: During 2 years after surgery). 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 6 Sep 2018.