Endoscopic Ultrasound Guided Versus Percutaneous Celiac Plexus Block in Patients With Intractable Upper Abdominal Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

Upper abdominal pain is a common and often debilitating symptom in patients with pancreatic cancer and chronic pancreatitis, and is frequently under-treated by standard opioid therapy despite dose escalation and associated side effects \[1\]. In chronic pancreatitis, abdominal pain is present in the great majority of patients and is often the dominant factor driving impaired quality of life, with celiac plexus block considered an interventional option for temporary relief \[2\]. Pain arising from both malignant and benign upper abdominal pathology is transmitted through the celiac plexus, an autonomic plexus located in the retroperitoneum at the root of the celiac trunk, making it a rational target for pain-relieving intervention in either disease process \[3\]. Two image-guided approaches have been developed to interrupt this pathway: the percutaneous route, performed under fluoroscopic or CT guidance \[5\], and the endoscopic ultrasound-guided route, performed transgastrically at the time of upper endoscopy, which allows direct visualization of the celiac plexus and may reduce the risk of injury to adjacent structures compared with the percutaneous approach \[3,9\]. Neurolytic celiac plexus block has been shown to improve pain relief in patients with unresectable pancreatic cancer \[6\], while EUS-guided celiac plexus block has similarly demonstrated efficacy in relieving pain associated with chronic pancreatitis \[7\]. Direct comparisons between the two approaches, however, remain limited: existing trials and meta-analyses in both chronic pancreatitis \[2,8\] and pancreatic cancer \[4,9\] show inconsistent superiority of one technique over the other, and the choice between them in practice has historically relied more on institutional expertise than on robust head-to-head evidence

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pancreatic cancer

Gastric cancer

Duodenal cancer

Biliary tract cancer (cholangiocarcinoma, gallbladder cancer)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endoscopic Ultrasound-Guided Celiac Plexus Block

    Procedure/Surgery

    Celiac plexus block via endoscopic ultrasound

  • Percutaneous Celiac Plexus Block

    Procedure/Surgery

    Celiac plexus block via percutaneous route image guided

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: EUS guided celiac plexus blockActive comparator 1 intervention
Group B: Percutaneous Celiac Plexus BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Pain Intensity from Baseline as Assessed by the Numerical Rating Scale (NRS)

Pain intensity assessed using the 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain. Comparison based on mean change from baseline between the EUS-guided and percutaneous groups.

Time frame
Time Frame: Baseline, 6 weeks, and 12 weeks post-procedure
2

Change in Pain Intensity from Baseline as Assessed by the Visual Analog Scale (VAS)

Pain intensity assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 mm (no pain) to 100 mm (worst pain imaginable). Higher scores indicate worse pain. Comparison based on mean change from baseline between groups.

Time frame
Baseline, 6 weeks, and 12 weeks post-procedure
3

Incidence of Procedure-Related Adverse Events

Number and percentage of participants experiencing procedure-related adverse events (e.g., bleeding, infection, hypotension, diarrhea, retroperitoneal hematoma), graded according to CTCAE v5.0 and compared between the EUS-guided and percutaneous groups

Time frame
Through 12 weeks post-procedure

Secondary outcomes

1

Duration of Pain Relief

Time from procedure to loss of at least 50% reduction in pain score (NRS/VAS) from baseline, reported in weeks.

Time frame
Up to 12 weeks post-procedure
2

Patient Satisfaction with Treatment

Assessed using a 5-point Likert Scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction.

Time frame
6 weeks and 12 weeks post-procedure
3

Patient Global Impression of Change (PGIC)

Assessed using the Patient Global Impression of Change scale, a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).

Time frame
6 weeks and 12 weeks post-procedure
4

Functional Disability as Assessed by the Oswestry Disability Index (ODI)

Functional disability assessed using the Oswestry Disability Index, scored as a percentage from 0% to 100%. Higher scores indicate greater disability.

Time frame
Baseline, 6 weeks, and 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: