Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis

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Brief Title

Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis

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

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.
    

Detailed Description

      Pain is the predominant symptom in patients with chronic pancreatitis (CP) and remains a
      considerable 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) and surgery have been used with varying success
      to treat pain. The rationale for endoscopic therapy or surgical drainage procedures is based
      on the hypothesis that obstruction of the pancreatic duct leads to ductal hypertension and
      pain. However, clinical pain symptoms correlate poorly with pancreatic ductal morphology and
      the response to endoscopic or surgical treatment is unpredictable, with long term response
      rates ranging from 30-60%. The evidence for these treatments are, however, based on
      case-series and comparison between different procedures, while no prospective sham controlled
      trials have evaluated the effectiveness of invasive treatments for pain in CP. In addition, a
      marked placebo effect has been observed in most trials of painful CP and this, together with
      the natural history of disease, needs consideration when treatment effects are evaluated.
      Therefore, the rationale behind invasive treatments for pain in CP treatments can be
      questioned.

      Recent meta-analyses have documented that the non-specific effects of surgery and other
      invasive procedures are generally large; particularly in the field of pain-related
      conditions. For example, arthroscopic meniscectomy for degenerative meniscal lesions has for
      many years been considered the state of the art treatment for this common condition. However,
      a high quality randomized controlled trial (RCT) and meta-analysis have not shown any
      differences in pain relieving effects between surgery and sham procedures for degenerative
      meniscal lesions. These findings challenge conventional wisdom and underline the necessity of
      properly conducted RCTs including a sham procedure, when the effectiveness of invasive
      procedures is evaluated.

      Albeit endoscopic therapy or surgery are widely used for pain in CP these treatments are only
      effective in a subset of patients. An improved understanding of the mechanisms underlying
      pain in CP suggest that the pain etiology in most patients is multifactorial and, in addition
      to the proposed mechanical mechanisms for pain (ductal obstruction/hypertension), a large
      body of evidence support a ´neuropathic pain phenotype´ with abnormal processing in the
      peripheral and central neural pathways. This likely explains the variable response to
      endoscopic and surgical treatments and underline an unmet need for biomarkers to identify
      responders to the different treatment modalities.

      Quantitative sensory testing (QST) can be used to investigate the state of the pain system;
      the technique is based on the rationale that different neural pathways and networks can be
      explored using standardized stimulation with simultaneous recording of the evoked pain
      response by psychophysical and/or objective methods. Due to spinal convergence between
      visceral afferents from the pancreas and somatic afferents from the Th10 skin dermatome,
      somatic QST can be reliable used to assess if the pain system is locally sensitized by
      nociceptive input from the pancreas (segmental sensitization). However, in many patients with
      chronic pain the pain system has become dysfunctional and has undergone a more universal
      sensitization. In such cases the QST profile of testing in several dermatomes together with
      specific test paradigms (temporal summation and assessment of descending inhibition) can be
      used to determine whether patients have abnormal central pain processing.

      The hypothesis of the present study is that combined ESWL and endotherapy induce short term
      (3 months) and mid-term (6 months) pain relief in patients with CP compared to a sham
      procedure. In addition, the investigators hypothesize that QST can be used to predict the
      outcome of combined ESWL and endoscopic therapy. Hence, patients with evidence of abnormal
      pain processing are hypothesized to have a worse outcome to treatment compared to patients
      with segmental or no evidence of sensitization.
    


Study Type

Interventional


Primary Outcome

Change from baseline pain score at 3 months

Secondary Outcome

 Ratio of responders versus non-responders

Condition

Chronic Pancreatitis

Intervention

ESWL

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

106

Start Date

October 1, 2019

Completion Date

October 1, 2021

Primary Completion Date

April 1, 2021

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT03966781

Organization ID

AIG/IEC28/04.2017-03


Responsible Party

Sponsor

Study Sponsor

Asian Institute of Gastroenterology, India

Collaborators

 Aalborg University Hospital

Study Sponsor

, , 


Verification Date

July 2020