To compare the efficacy of P-SNN to EUS-CGN with regard to decreasing chronic malignant pain in patients with inoperable intra-abdominal malignancies.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameter is the difference in short-term efficacy between P-SNN
and EUS-CGN.
• Pain is measured using a 11-point numeric rating scale (0-10) for upper
abdominal or back pain, due to an inoperable intra-abdominal malignancy. The
pain score used to determine the primary outcome will be assessed seven days
after the procedure. This is compared to the patients baseline pain score in
order to determine the reduction in pain (=efficacy).
• Baseline pain score is based on an assessment by the patient. The average
pain score from the three consecutive days prior to the procedure will be used
to determine the baseline pain score.
Secondary outcome
• Pain reduction as a result of P-SNN compared to EUS-CGN, expressed as the
percentage reduction in pain 7 days after the procedure. This will be compared
to the average pain score of the three consecutive days prior to the procedure
(=baseline pain score).
• Long-term efficacy, assessed using the pain score at twelve weeks after the
procedure. If a patient dies before this time, the last filled out pain score
will be used.
• Difference in complete response (pain score <=1, seven days after the
neurolysis) between P-SNN and EUS-CGN.
• Opioid usage pre- and post-neurolysis, converted to daily oral morphine
equivalents.(Levy 1996)
• Major complications related/not related to neurolysis procedure (either
P-SNN or EUS-CGN); defined as complications leading to hospitalization,
unintended prolongation of hospitalization, death or repeat (endoscopic)
intervention with/without a possible or definite association with neurolysis
procedure as determined by the treating physician.
• Minor complications related/not related to neurolysis procedure; defined as
minor complications with/without a possible or definite association with
neurolysis procedure as determined by the treating physician.
• Common opioid related adverse events: nausea, pruritus, constipation, and
drowsiness.
• Side-effects of neurolysis; defined as transient diarrhea, back pain or
orthostatic hypotension up to 3 days post-neurolysis.
• Technical success; successful injection of phenol at the correct location, as
confirmed with fluoroscopy. Judgment is made by the physician performing the
procedure.
• Experience of the patient (in patients who were awake during the procedure)
• EQ5D quality of life questionnaire prior to the procedure, a week, two weeks
and four weeks after the procedure and then monthly up to 12 months.
• Costs of both approaches.
• Time required for both procedures.
• Pain diary first week, diary evaluating side-effects first week.
• Survival in both groups (after stratifying for disease and disease state).
Background summary
Patients with intra-abdominal malignancies, especially pancreatic carcinoma,
are often inoperable at the time of diagnosis. For those patients, palliative
therapy is the only option. Intra-abdominal malignancies are often associated
with severe chronic pain. Celiac plexus neurolysis (CPN), either as a
replacement or in addition to opioid usage, is an effective treatment option.
Traditionally, percutaneous CPN (P-CPN) is performed by an anesthesiologist. A
type of P-CPN is splanchnic nerve neurolysis (P-SNN), where the nerves are
damaged more cranially than with a celiac plexus neurolysis. Reaching the
celiac plexus using endoscopic ultrasound (EUS) is a good, if not better,
alternative. Recently, injection of a neurolytic agent with EUS directly in the
celiac ganglia (EUS-CGN) proved superior to EUS-CPN. Direct comparison between
P-SNN and EUS-guided neurolysis in malignant intra-abdominal pain has not been
performed. Therefore, we set out to perform such a study. Since EUS-CGN proved
superior to EUS-CPN, this technique will be used. We hypothesize that EUS-CGN
is more effective in achieving adequate pain reduction in malignant
upper-abdominal pain or back pain than P-SNN.
Study objective
To compare the efficacy of P-SNN to EUS-CGN with regard to decreasing chronic
malignant pain in patients with inoperable intra-abdominal malignancies.
Study design
Single center, open label, randomized controlled trial.
Intervention
Patients are randomized to undergo either endoscopic ultrasound-guided celiac
ganglia neurolysis or percutaneous splanchnic nerve neurolysis.
Study burden and risks
The burden for participation is limited. The procedure is performed as per
standard protocol. Follow-up consists of calls of approximately 5-10 minutes
after the first, second and fourth week and monthly thereafter. The maximum
follow-up duration is six months. Both procedures are part of standard clinical
care. Therefore, there are no additional risks involved with study
participation. Known risks associated with CPN are; lower extremity weakness,
paresthesia, pneumothorax and hematuria. Side-effects include local pain,
transient diarrhea and transient hypotension. Severe adverse events are
expected to occur equally among the two groups. As it is currently not known
whether EUS-CGN is indeed more effective in reducing malignant intra-abdominal
pain than P-SNN , the benefit of study participation is uncertain. A possible
advantage is that patients are closely monitored. Should the pain recur,
appropriate action can be taken quickly. Should EUS-CGN proof more effective as
hypothesized, a subset of patients will benefit from participation in this
trial since P-CPN is performed much more frequently than EUS-CGN in our
hospital in daily practice.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
• Diagnosis of an inoperable malignant tumor in the upper abdomen by histopathological or imaging findings.
o Inoperable malignancy is defined as local tumor infiltration into surrounding organs, distant metastases or a poor general health due to serious concomitant disease.
• Baseline pain score of >=4 on a 11-point numeric rating scale (0-10) for upper abdominal or back pain. This is assessed on the three consecutive days prior to the procedure and the average score is used as a baseline pain score.
• >17 years old.
Exclusion criteria
• Previous CPN
• Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study
• Coagulopathy (INR>1.5, platelets<50.000/mm3) which has not been corrected prior to the procedure
• Pregnancy
• Previous participation in this trial
• Severe allergy to contrast
• Systemic infection or infection at the location of the 11th thoracic vertebra
• Karnofsky performance scale of <30%
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45617.041.14 |