Pancreatic CancerPhase 2NCT04449289
Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery
A Phase 2 study testing Intravenous lidocaine and Epidural ropivacaine in people with Pancreatic Cancer, run by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor at 1 site in Romania.
Trial summary
Study aims to compare the influence of intravenous lidocaine and peridural ropivacaine on postoperative long and short term outcome in patients with pancreatic cancer undergoing surgery. As short term endpoints: postoperative complications and resumption of bowel function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Intravenous lidocaine and Epidural ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jul 2020to 31 Dec 2024
- Phase
- Phase 2
- 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
- diagnosis of pancreatic cancer
- American Society of Anesthesiologists (ASA) risk I - III
Who cannot join
- chronic pain
- chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
- contraindications for any of the study medications
- significant psychiatric disorders (major depression, bipolar disorders, schizophrenia, etc.)
- Convulsive disorders requiring medication during the last 2 years
- liver cirrhosis/chronic kidney disease stage IV or V/chronic heart failure class III or IV/ decompensated diabetes
Show all 10Show fewer
- Corticoid dependent asthma
- Autoimmune disorders
- Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
- Refusal for study participation
Trial locations and contacts
1 site in 1 country.
Romania1 site
Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"
Cluj-Napoca
Theodor Bot, 0040765350176, theo_bot@yahoo.com
About this study
Study aims to compare the influence of intravenous lidocaine and peridural ropivacaine on postoperative long and short term outcome in patients with pancreatic cancer undergoing surgery.
As short term endpoints: postoperative complications and resumption of bowel function.
Long term endpoints include: 1 and 3 year recurrence and mortality.
- Conditions
- Pancreatic Cancer
- Being tested
- Intravenous lidocaine, Epidural ropivacaine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous lidocaineDrug
Intraoperatively and postoperatively a standard intravenous infusion of lidocaine will be used for analgesia
Epidural ropivacaineDrug
Intraoperatively and postoperatively an epidural infusion of ropivacaine will be used for analgesia
| Study group | Role | What they receive |
|---|---|---|
| Intravenous lidocaine | Active comparator | Patients will be subjected to anesthesia with sevoflurane+fentanyl+intravenous lidocaine infusion for the first 48 hours postoperative Receives: Drug: Intravenous lidocaine |
| Epidural ropivacaine | Active comparator | Patients will be subjected to anesthesia with sevoflurane+fentanyl+epidural ropivacaine infusion for the first 48 hours postoperatively Receives: Drug: Epidural ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- and 3-years recurrence rate after surgery
Study participants will be contacted by study team via phone or e-mail
Measured: 3 years
Secondary outcomes (3)
1- and 3-years survival after surgery
Study participants will be contacted by study team via phone or e-mail
Measured: 3 years
Lidocaine and ropivacaine concentration
Measured: Intraoperatively
Complication rate after surgery
Resumption of bowel function, anastomotic leakage or hemorrhage
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2024 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodor Bot, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Investigators
- Daniela Ionescu, MD PhD, Study director, Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449289
- Sponsor's protocol ID
- 43/3.02.2020
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery
- ClinicalTrials.gov ID
- NCT04449289
- Acronym / sponsor ID
- 43/3.02.2020
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian FodorUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jun 2020 (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.
Study aims to compare the influence of intravenous lidocaine and peridural ropivacaine on postoperative long and short term outcome in patients with pancreatic cancer undergoing surgery.
As short term endpoints: postoperative complications and resumption of bowel function.
Long term endpoints include: 1 and 3 year recurrence and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous lidocaine | Active comparator | Drug: Intravenous lidocainePatients will be subjected to anesthesia with sevoflurane+fentanyl+intravenous lidocaine infusion for the first 48 hours postoperative |
| Epidural ropivacaine | Active comparator | Drug: Epidural ropivacainePatients will be subjected to anesthesia with sevoflurane+fentanyl+epidural ropivacaine infusion for the first 48 hours postoperatively |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of pancreatic cancer
- American Society of Anesthesiologists (ASA) risk I - III
Key exclusion criteria (10 listed)
- chronic pain
- chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
- contraindications for any of the study medications
- significant psychiatric disorders (major depression, bipolar disorders, schizophrenia, etc.)
- Convulsive disorders requiring medication during the last 2 years
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 |
|---|---|---|
| Intravenous lidocaineIntraoperatively and postoperatively a standard intravenous infusion of lidocaine will be used for analgesia | Drug | Intravenous lidocaine |
| Epidural ropivacaineIntraoperatively and postoperatively an epidural infusion of ropivacaine will be used for analgesia | Drug | Epidural ropivacaine |
Primary outcome
1- and 3-years recurrence rate after surgery
Time frame: 3 years
Study participants will be contacted by study team via phone or e-mail
3 secondary outcomes
1- and 3-years survival after surgery
Time frame: 3 years
Lidocaine and ropivacaine concentration
Time frame: Intraoperatively
Complication rate after surgery
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Daniela Ionescu, MD PhD study director
Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous lidocaine and Epidural ropivacaine in people with Pancreatic Cancer, run by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor at 1 site in Romania.
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 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: status not confirmed, as of the sponsor's last update on 26 Jun 2020. 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 Romania. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Theodor Bot, PhD Student (0040765350176, theo_bot@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1- and 3-years recurrence rate after surgery (time frame: 3 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 26 Jun 2020.