Elsevier

Gastrointestinal Endoscopy

Volume 74, Issue 6, December 2011, Pages 1300-1307
Gastrointestinal Endoscopy

Original article
Clinical endoscopy
A prospective, randomized study of EUS-guided celiac plexus neurolysis for pancreatic cancer: one injection or two?

https://doi.org/10.1016/j.gie.2011.07.073Get rights and content

Background

The technique of alcohol injection during EUS-guided celiac plexus neurolysis (CPN) in patients with pancreatic cancer–related pain has not been standardized.

Objective

To compare pain relief and safety of alcohol given as 1 versus 2 injections during EUS-guided CPN (EUS-CPN). Secondary outcomes examined were characteristics that predict response and survival.

Design

Single-blinded, prospective, randomized, parallel-group study.

Setting

Tertiary-care center.

Patients

This study involved patients with pancreatic cancer–related pain.

Intervention

EUS-CPN done by injecting 20 mL of 0.75% bupivacaine and 10 mL 98% alcohol into 1 or 2 sites at the celiac trunk. Participants were interviewed by telephone at 24 hours and weekly thereafter.

Main Outcome Measurements

Time until onset of pain relief, duration of pain relief, complications.

Results

Fifty patients (mean age 63 years; 24 men) were enrolled and randomized (29 in 1-injection, 21 in 2-injections groups). Pain relief was observed in 37 (74%) patients: 20 (69%) in the 1-injection group and 17 (81%) in the 2-injection group (chi-square P = .340). Median onset of pain relief was 1 day for both 1-injection (range 1-28 days) and 2-injection (range 1-21 days) groups (Mann-Whitney P = .943). Median duration of pain relief in the 1-injection and 2-injection groups was 11 weeks and 14 weeks, respectively (log-rank P = .612). Complete pain relief was observed in 4 (8%) patients total, 2 in each group. There were no long-term complications.

Limitations

Single-blinded study.

Conclusion

There were no differences in onset or duration of pain relief when either 1 or 2 injections were used. There was no difference in safety or survival between the 2 groups. (Clinical trial registration number: NCT00583479.)

Section snippets

Methods

This study was approved by the Institutional Review Board at Indiana University Medical Center/Indiana University Health. This was a single-center, randomized (1:1), single-blinded, parallel-group study. Patients with known or suspected pancreatic cancer–related pain secondary to pancreatic adenocarcinoma were eligible. Consecutive patients with known or suspected pancreatic cancer–related pain were enrolled by a nurse who was involved with data collection. Patients were excluded if they had an

Results

Fifty patients were enrolled over a 70-month period (December 2002 through September 2008). Enrollment is demonstrated in Figure 3. Patient characteristics are shown in Table 1. Twenty-nine (58%) patients had EUS staging and EUS-CPN performed at the same time. One patient had a prior 1-injection EUS-CPN 5 months before study entry and experienced 3 months of pain relief. The other patient had a prior 2-injection EUS-CPN 4.5 months before study entry; however, the duration of pain relief is not

Discussion

There was no difference in onset or duration of pain relief between the 2 groups. Pain relief was achieved in 74% of patients. These results support our hypothesis that altering the technique of injection between 1 and 2 did not alter pain relief onset or duration. This observation is likely explained by the equivalent distribution of the total amount of neurolytic agent into the celiac region, regardless of injection technique. Our study contributes several new findings of EUS-CPN. First,

Conclusions

Our study supports the use of a single injection during EUS-CPN in patients with unresectable pancreatic cancer and pancreatic cancer–related pain. Our results are generalizable to patients with pancreatic cancer–related pain. We found no differences between the 1-injection and 2-injection groups with respect to onset of pain relief, duration of pain relief, complete response, complications, or survival. Although both 1-injection and 2-injection methods were equally safe and efficacious, a

References (18)

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    Citation Excerpt :

    At week two and four, the proportions reporting analgesic response were 67% (95% CI 56%–79%) (I2 = 72.4%, P < 0.05) and 46% (95% CI 36%–55%) (I2 = 0.00) (P < 0.05) respectively (Figs. 2 and 3). Three parallel group RCTs provided direct comparison between central and bilateral injection techniques [25,33,34]. All of them showed higher response rates in their bilateral injection groups but none of them reached statistical significance.

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DISCLOSURE: C. Johnson is a stockholder in Eli Lilly & Co. No other financial relationships relevant to this publication were disclosed.

If you would like to chat with an author of this article, you may contact Dr LeBlanc at [email protected].

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