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Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis

NCT03966781 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-09-29

No results posted yet for this study

Summary

Pain is a common symptom of chronic pancreatitis and remains a significant therapeutic challenge. In patients with pathological changes of the pancreatic duct, including stones and strictures, endoscopic procedures with or without preceding extracorporeal shock wave lithotripsy (ESWL) have been used with varying success to treat pain, but high quality evidence is lacking so support this practice. The main objective of this study is to investigate the pain-relieving effects of combined ESWL and endotherapy in patients with painful CP in comparison with sham treatment.

Conditions

Interventions

PROCEDURE

ESWL

ESWL will be conducted under epidural anesthesia. For epidural anesthesia, bupivacaine will be used to block the T6-T12 spinal segments. The patient's eyes will be lightly covered all along the procedure. Once epidural anesthesia is achieved, the patient will be given a light sedation and ESWL will be performed using a Dornier dual focus lithotripsy system providing a maximum of 5000 at the rate of 90 shocks per minute in over 1-2 days.

PROCEDURE

ERCP

Once ESWL is over, an endoscopic pancreatic sphincterotomy will be performed and complete stone removal will be attempted with subsequent stenting of the pancreatic duct in the presence of a pancreatic stricture (not detected on MRCP prior to enrolment) or in case of incomplete stone removal

PROCEDURE

Sham ESWL

In the sham/control group, patients will be given a transient superficial pin-prick sensation to give the feel of epidural anesthesia. After that the lithotripsy machine the will be switched on, without establishing any form of contact with the patients body.

PROCEDURE

Sham ERCP

Following sham ESWL patientswill be subjected to sham ERCP to examine the papillary area, but no pancreatic ductal intervention will be performed.

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Asian Institute of Gastroenterology, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-03-23
Completion
2023-03-23

Countries

  • India

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03966781 on ClinicalTrials.gov