Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis

NCT03966781 | Completed DMC

• 1 other identifier: AIG/IEC28/04.2017-03
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Pancreatitis; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change from baseline pain score at 3 months

  The primary clinical endpoint is pain relief. Average and maximal daily clinical pain intensity scores will be recorded in a patient pain diary based on a 0-10 visual analogy scale (VAS), with registration of the baseline pain intensity scores the week prior to intervention and weekly recordings continued for a 3 months period after intervention. Mean values of pain scores will be calculated over 1 week to adjust for day-to-day variability in pain intensity. The difference in pain scores between patients receiving active treatment (ESWL and ERCP) and sham treatment are compared, with the primary comparison of average pain scores 3 months after intervention. Weekly telephone interviews from a study co-ordinator will be undertaken to facilitate accurate registration and compliance pain score).

  3 months after intervention

Secondary Outcomes (10)

• Ratio of responders versus non-responders

  3 and 6 months after intervention

• Change in analgesic consumption

  3 and 6 months after intervention

• Hospitalization

  3 and 6 months after intervention

• Change in quality of life (EORTC-QLQ C 30)

  3 and 6 months after intervention

• Changes in pain and physical functioning composite scores (BPI-sf)

  3 and 6 months after intervention

Other Outcomes (1)

• Quantitative sensory testing (characterization of pain processing)

  3 and 6 months after intervention

Study Arms (2)

ESWL followed by ERCP

ACTIVE COMPARATOR

Patients enrolled in the active treatment group will be subjected to ESWL followed by ERCP and pancreatic duct stenting.

Procedure: ESWL; Procedure: ERCP

Sham ESWL followed by sham ERCP

SHAM COMPARATOR

Patients enrolled in the sham treatment group will be subjected to sham ESWL followed by sham ERCP with no pancreatic duct intervention.

Procedure: Sham ESWL; Procedure: Sham ERCP

Interventions

ESWL PROCEDURE

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.

ESWL followed by ERCP

ERCP PROCEDURE

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

ESWL followed by ERCP

Sham ESWL PROCEDURE

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.

Sham ESWL followed by sham ERCP

Sham ERCP PROCEDURE

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

Sham ESWL followed by sham ERCP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from the ages of 18 with a diagnosis of chronic calcific pancreatitis diagnosed using the Mayo Clinic diagnostic criteria. Both diabetic and non-diabetic patients will be allowed to enter the study.
• The patients must suffer from chronic abdominal pain characteristic for CP with a pain intensity \>3 VAS on a 0-10 VAS and meet the criteria for chronic pain (pain ≥ 3 days per week in at least 3 months).
• Obstruction of the pancreatic duct due to intraductal stones with dilatation of the duct proximal to the obstruction, as determined by magnetic resonance cholangiopancreatography, abdominal computed tomography, or both.
• The patients must be able to read and understand the provided informed consent.
• Patients must personally sign and date informed consent document indicating that he/she has been informed of all pertinent aspects of the trial.
• Patients should be willing to comply with the scheduled visits, clinical and experimental assessment plan, and other trial procedures.

You may not qualify if:

• Patients with any clinically significant laboratory abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
• Previous history of pancreatic surgery, ESWL or ERCP.
• Patients with a pancreatic stricture on cross-sectional imaging prior to study enrolment
• Active alcohol or illegal drug dependencies.
• Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
• Patients must not suffer from painful conditions other than CP that make them unable to distinguish the pain associated with CP from chronic pain of other origin.
• Presence of pancreatic head mass, multiple strictures, large ascites, large fluid collections.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, 500082, India

Location

Related Publications (2)

• Talukdar R, Olesen SS, Unnisa M, Bedarkar A, Sarkar S, Tandan M, Jagtap N, Darisetty S, Kiran S, Koppoju V, Lakhtakia S, Ramchandani M, Kalapala R, Gupta R, Singh VK, Rao GV, Reddy DN, Drewes AM. Extracorporeal Shock-Wave Lithotripsy and Endoscopy for the Treatment of Pain in Chronic Pancreatitis : A Sham-Controlled, Randomized Trial. Ann Intern Med. 2024 Jun;177(6):749-758. doi: 10.7326/M24-0210. Epub 2024 May 28.

  PMID: 38801774 DERIVED

• Olesen SS, Drewes AM, Gaud R, Tandan M, Lakhtakia S, Ramchandani M, Rao GV, Reddy DN, Talukdar R. Combined extracorporeal shock wave lithotripsy and endoscopic treatment for pain in chronic pancreatitis (SCHOKE trial): study protocol for a randomized, sham-controlled trial. Trials. 2020 Apr 16;21(1):338. doi: 10.1186/s13063-020-04296-0.

  PMID: 32299454 DERIVED

MeSH Terms

Conditions

Pancreatitis, Chronic; Chronic Pain

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2019
• First Posted: May 29, 2019
• Study Start: February 1, 2021
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

IN (1)