Pancreatic Cancer PainNCT01615653
EUS Guided Celiac Neurolysis
A study testing EUS in people with Pancreatic Cancer Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
Hypothesis: Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer Pain
- What is being tested?
- EUS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
- 2. Cytologic or histologic confirmation of pancreatic carcinoma
- 3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
- 4. EUS clinically indicated (for non-study purposes)
Who cannot join
- 1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000
- 2. Abdominal surgery within 1 month
- 3. Prior celiac plexus or ganglia neurolysis.
- 4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
- 5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain
- Hypothesis:
- Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
- Rationale:
- Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.
- Conditions
- Pancreatic Cancer Pain
- Being tested
- EUS
- Keywords
- Pancreatic cancer, Pancreas cancer, Pain, Celiac Plexus, Neurolysis
- Medical subject headings
- Pancreatic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUSProcedure or surgery
EUS Guided Therapy
| Study group | Role | What they receive |
|---|---|---|
| EUS 1 | Active comparator | Not described Receives: Procedure: EUS |
| EUS 2 | Active comparator | Not described Receives: Procedure: EUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed using a numerical rating scale (NRS) from 0 to 10.
pain response will be measured
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startSep 2009
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Gastroenterology
- Responsible party
- Principal investigator, Michael Levy, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615653
- Sponsor's protocol ID
- 09-005037
- Status last verified
- Jul 2017
- First submitted
- 17 Apr 2012
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Levy MJ, Gleeson FC, Topazian MD, Fujii-Lau LL, Enders FT, Larson JJ, Mara K, Abu Dayyeh BK, Alberts SR, Hallemeier CL, Iyer PG, Kendrick ML, Mauck WD, Pearson RK, Petersen BT, Rajan E, Takahashi N, Vege SS, Wang KK, Chari ST. Combined Celiac Ganglia and Plexus Neurolysis Shortens Survival, Without Benefit, vs Plexus Neurolysis Alone. Clin Gastroenterol Hepatol. 2019 Mar;17(4):728-738.e9. doi: 10.1016/j.cgh.2018.08.040. Epub 2018 Sep 12.
PubMed 30217513
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain
- ClinicalTrials.gov ID
- NCT01615653
- Acronym / sponsor ID
- 09-005037
- Conditions
- Pancreatic Cancer Pain
- Keywords
- Pancreatic cancer, Pancreas cancer, Pain, Celiac Plexus, Neurolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- American College of Gastroenterology
- Study start
- Sep 2009 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Jun 2012 (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.
- Hypothesis:
- Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
- Rationale:
- Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS 1 | Active comparator | Procedure: EUS |
| EUS 2 | Active comparator | Procedure: EUS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
- 2. Cytologic or histologic confirmation of pancreatic carcinoma
- 3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
- 4. EUS clinically indicated (for non-study purposes)
Key exclusion criteria (5 listed)
- 1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000
- 2. Abdominal surgery within 1 month
- 3. Prior celiac plexus or ganglia neurolysis.
- 4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
- 5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.
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 |
|---|---|---|
| EUSEUS Guided Therapy | Procedure or surgery | EUS 1, EUS 2 |
Primary outcome
Pain assessed using a numerical rating scale (NRS) from 0 to 10.
Time frame: Baseline to 6 months
pain response will be measured
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 25 Jul 2017.
- Derived from this study: PubMed 30217513Levy MJ, Gleeson FC, Topazian MD, Fujii-Lau LL, Enders FT, Larson JJ, Mara K, Abu Dayyeh BK, Alberts SR, Hallemeier CL, Iyer PG, Kendrick ML, Mauck WD, Pearson RK, Petersen BT, Rajan E, Takahashi N, Vege SS, Wang KK, Chari ST. Combined Celiac Ganglia and Plexus Neurolysis Shortens Survival, Without Benefit, vs Plexus Neurolysis Alone. Clin Gastroenterol Hepatol. 2019 Mar;17(4):728-738.e9. doi: 10.1016/j.cgh.2018.08.040. Epub 2018 Sep 12.
Related trials for Pancreatic Cancer Pain
RecruitingPhase 1
Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy (SBRT) in Participants With Cancer-Related Celiac Pain
Pancreatic Cancer, Retroperitoneal Pain Syndrome
RecruitingObservational study
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
Breast Cancer, Benign Breast Condition
Not yet recruiting
Outcomes of Fluoroscopy-Guided Transdiscal Splanchnic Nerve Neurolysis for Upper Abdominal Cancer Pain.
Upper Abdominal Cancer Pain, Pancreatic Cancer
Not yet recruiting
Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer
Pancreatic Cancer Pain, Intrathecal Analgesic
Not yet recruiting
Scheduled Meditation for Improving Postoperative Outcomes in Patients Undergoing Pancreatectomy
Hepatocellular Carcinoma, Pancreas Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS in people with Pancreatic Cancer Pain, run by Mayo Clinic 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 4 inclusion and 5 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 25 Jul 2017. 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. 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 assessed using a numerical rating scale (NRS) from 0 to 10. (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01615653, which also lists 1 linked publication.
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 25 Jul 2017.