Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis

NACompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

March 23, 2023

Study Completion Date

March 23, 2023

Conditions
Chronic PancreatitisChronic Pain
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.

Trial Locations (1)

500082

Asian Institute of Gastroenterology, Hyderabad

All Listed Sponsors
collaborator

Aalborg University Hospital

OTHER

lead

Asian Institute of Gastroenterology, India

OTHER

NCT03966781 - Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis | Biotech Hunter | Biotech Hunter