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Pancreatic NeoplasmsNCT02220062

Randomized, Controlled Trial of Endoscopic Ultrasound-Guided Bilateral Celiac Plexus Neurolysis vs Celiac Ganglia Neurolysis to Control Pain in Inoperable Pancreatic Cancer Patients With Inadequate Pain Control by Pain Killer

A study testing EUS-CPN and EUS-CGN in people with Pancreatic Neoplasms, run by Samsung Medical Center.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Pancreatic cancer related pain can be difficult to control, even with high doses of narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic ultrasound guided celiac plexus neurolysis) is well established as an effective technique for controlling pain and reducing narcotic… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
EUS-CPN and EUS-CGN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
No sites listed yet
Study dates
Aug 2014to Aug 2016
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 19 years old age (above 70 years old age, need the consent of the legal representative)
  • Inoperable pancreatic cancer patients
  • Pancreatic cancer patients with inadequate pain control by pain killer (VAS score 4 points or more)
  • Patient who agree to participate in this study

Who cannot join

  • Abnormal clotting (international normalized ratio ≥1.5)
  • Reduced platelet count (≤50000/μL)
  • Use of anticoagulation agents
  • Presence of gastric and/or esophageal varices
  • Anatomical deformity due to past surgery

About this study

Pancreatic cancer related pain can be difficult to control, even with high doses of narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic ultrasound guided celiac plexus neurolysis) is well established as an effective technique for controlling pain and reducing narcotic requirements in patients with pancreatic cancer. Recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. So it allows for direct injection into individual celiac ganglia to perform celiac ganglia neurolysis. This more precise delivery of therapeutic drug will offers the potential for enhanced efficacy and safety. To evaluate this hypothesis, this randomized controlled trial aimed to compare the efficacy and safety of EUS-CGN(Endoscopic ultrasound guided celiac ganglia neurolysis) vs. Bilateral EUS-CPN(Endoscopic ultrasound guided celiac plexus neurolysis) in providing relief from pancreas cancer-related pain.

Being tested
EUS-CPN, EUS-CGN
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EUS-CPNProcedure or surgery

    After initially identifying the celiac trunk on endoscopic ultrasound, each injection of 5~10cc ethanol would be performed as bilateral injections at the celiac trunk.

  • EUS-CGNProcedure or surgery

    First, identify celiac ganglia. If the celiac ganglia are visualized under linear EUS, the injection of 2~3cc ethanol are applied directly into the each ganglia. If the ganglia are not identified by EUS, bilateral EUS-CPN would be performed

Study groups in NCT02220062
Study groupRoleWhat they receive
EUS-CPN groupActive comparatorGroup that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis
Receives: Procedure: EUS-CPN
EUS-CGN groupExperimentalGroup that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis
Receives: Procedure: EUS-CGN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS)

    Measured: 1 week after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionAug 2016 (estimated)

Resources

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
Single blind
Who is masked
Participant
Enrolment
166 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02220062
Sponsor's protocol ID
2014-02-088-005
Status last verified
Aug 2014
First submitted
21 Jul 2014
Last updated
19 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing EUS-CPN and EUS-CGN in people with Pancreatic Neoplasms, run by Samsung Medical Center.

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: status not confirmed, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS) (time frame: 1 week after procedure). 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 NCT02220062.

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 19 Aug 2014.

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