Pancreas CancerNCT02002806
Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control
A study testing Alcohol Injection in people with Pancreas Cancer and Biliary Tract Cancer, run by Indiana University at 1 site in United States.
Trial summary
This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreas Cancer, Biliary Tract Cancer
- What is being tested?
- Alcohol Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study will be offered to all patients scheduled to undergo open or laparoscopic operative resection of a presumed pancreatic (any location; i.e., head, body, or tail) or distal biliary tract cancer.
- Physiologic suitability for major abdominal surgery
- Aged 18 years and older
- Written informed consent
- Ability to understand and comply with study guidelines.
Who cannot join
- Pregnancy
- Previous, preoperative celiac nerve block
- Neoadjuvant chemotherapy or radiation therapy
- Incomplete tumor resection (R2 resection, grossly positive resection margin)
- Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative findings
- Benign tumors, neuroendocrine tumors, soft tissue tumors based on preoperative work-up or intraoperative findings
- Known metastatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies
This is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.
Read the detailed description
Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct cancer.
Subjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with ethanol injection versus surgery plus placebo injection. Subjects will be followed every three months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of pain control will be determined at one year post surgery. Subjects are not required to undergo any additional diagnostic testing procedures that are not part of their routine follow-up care.
- Conditions
- Pancreas Cancer, Biliary Tract Cancer
- Being tested
- Alcohol Injection, Placebo Injection
- Keywords
- Pancreatic cancer, Pain
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol InjectionOther
Also called Ethanol Injection
Celiac plexus neurolysis by alcohol injection
Placebo InjectionOther
Also called Normal saline injection
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Injection | Experimental | Celiac plexus neurolysis by alcohol injection One time administration during surgery 20 ml of alcohol injection on each side of aorta at level of celiac axis Receives: Other: Alcohol Injection |
| Placebo Injection | Placebo comparator | Celiac plexus injection - placebo injection Receives: Other: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Control
Measured: 12 Months
Secondary outcomes (1)
Disease-specific, recurrence-free survival
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael G. House, Indiana University
- Investigators
- Michael G House, MD, Principal investigator, Indiana University, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002806
- Sponsor's protocol ID
- 1011003552
- Status last verified
- Aug 2019
- First submitted
- 2 Dec 2013
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Intraoperative Chemical Splanchnicectomy for Patients With Resected Pancreatobiliary Malignancies
- ClinicalTrials.gov ID
- NCT02002806
- Acronym / sponsor ID
- 1011003552
- Conditions
- Pancreas Cancer, Biliary Tract Cancer
- Keywords
- Pancreatic cancer, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 6 Dec 2013 (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 is a randomized study of surgery plus chemical nerve block versus surgery plus placebo for pain control in subjects with pancreatic cancer.
Detailed description
Thi is a study of pain control in subjects undergoing surgery for pancreatic or bile duct cancer.
Subjects undergoing surgery will be randomized to surgery plus celiac plexus neurolysis with ethanol injection versus surgery plus placebo injection. Subjects will be followed every three months for survivorship or death to assess pain, quality of life measures, and narcotic pain control usage. The primary endpoint of pain control will be determined at one year post surgery. Subjects are not required to undergo any additional diagnostic testing procedures that are not part of their routine follow-up care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol Injection | Experimental | Other: Alcohol InjectionCeliac plexus neurolysis by alcohol injection One time administration during surgery 20 ml of alcohol injection on each side of aorta at level of celiac axis |
| Placebo Injection | Placebo comparator | Other: Placebo InjectionCeliac plexus injection - placebo injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- This study will be offered to all patients scheduled to undergo open or laparoscopic operative resection of a presumed pancreatic (any location; i.e., head, body, or tail) or distal biliary tract cancer.
- Physiologic suitability for major abdominal surgery
- Aged 18 years and older
- Written informed consent
- Ability to understand and comply with study guidelines.
Key exclusion criteria (7 listed)
- Pregnancy
- Previous, preoperative celiac nerve block
- Neoadjuvant chemotherapy or radiation therapy
- Incomplete tumor resection (R2 resection, grossly positive resection margin)
- Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative findings
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 |
|---|---|---|
| Alcohol InjectionAlso: Ethanol InjectionCeliac plexus neurolysis by alcohol injection | Other | Alcohol Injection |
| Placebo InjectionAlso: Normal saline injection | Other | Placebo Injection |
Primary outcome
Pain Control
Time frame: 12 Months
1 secondary outcome
Disease-specific, recurrence-free survival
Time frame: 2 Years
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 16 Aug 2019.
- 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.
Michael G House, MD principal investigator
Indiana University, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Injection in people with Pancreas Cancer and Biliary Tract Cancer, run by Indiana University at 1 site in United States.
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 5 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 16 Aug 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Pain Control (time frame: 12 Months). 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 16 Aug 2019.