Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis
CompletedNot applicableNCT03966781
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Randomized, Single-blinded, Single-center, Parallel-group, Sham-controlled, Prospective Trial of Combined Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis
- Conditions
- Interventions
- Procedure: ESWL
- Procedure: ERCP
- Procedure: Sham ESWL
- Procedure: Sham ERCP
- Sponsor
- Asian Institute of Gastroenterology, India
- Collaborators
- Aalborg University Hospital
- Start date
- 2021-02-01
- Primary completion
- 2023-03-23
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- India
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03966781