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Endoscopic Versus Surgical Treatment of Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT01520675
Recruitment Status : Active, not recruiting
First Posted : January 30, 2012
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Pramod Kumar Garg, All India Institute of Medical Sciences, New Delhi

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Chronic pancreatitis is a progressive inflammatory disease of the pancreas characterized by destruction of pancreatic parenchyma and subsequent fibrosis. Patients with chronic pancreatitis can be treated with medical management, endoscopic therapy and surgical treatment. Among the various theories of causation of pain in chronic pancreatitis, there is theory of ductal hypertension. In this the pancreatic duct obstruction resulting in ductal dilatation, ductal hypertension and parenchymal hypertension is thought to be the cause of pain. For patients with dilated ducts, ductal decompression is advocated. Ductal decompression can be achieved by endoscopy and by surgery. Surgery comprises of lateral pancreaticojejunostomy with or without headcoring. Endoscopic treatment includes sphincterotomy, dilatation of strictures, removal of stones with or without extracorporeal shock wave lithotripsy (ESWL) and stenting. The pros and cons of endoscopic versus surgical therapy are debated. Lateral pancreaticojejunostomy relieves chronic abdominal pain in 65%-93% of patients. Morbidity and mortality rates are generally low, averaging 20% and 2%, respectively. Long-term follow-up of patients after lateral pancreaticojejunostomy reveals that up to 50% of patients develop recurrent symptoms and 10%-35% fail to obtain pain relief. Studies indicate that more than 60% of patients undergoing pancreatic endotherapy are pain free 1 year after the procedure. There are only two randomized controlled trials comparing endoscopic treatment with the surgical therapy. In this study the investigators will be conducting a randomized trial, to compare endoscopic and surgical treatment of chronic pancreatitis. Outcome variables measured in the study will include pain relief, quality of life, morbidity, mortality, length of hospital stay and changes in pancreatic function.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Procedure: surgery Procedure: Endoscopic therapy Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Versus Surgical Treatment of Chronic Pancreatitis - A Randomized Controlled Trial
Actual Study Start Date : July 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Surgery
Patients will be randomized to surgery
 Procedure: surgery
Drainage procedure
Other Name: lateral pancreaticojejunostomy
Active Comparator: Endotherapy
Patients will be randomized to endoscopic therapy
 Procedure: Endoscopic therapy
pancreatic sphincterotomy, removal of calculi, stenting, ESWL
Other Name: Pancreatic endotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Pain relief [ Time Frame: 1 year ]
    Relief in pain


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 6 Month ]
    QoL score

  2. Morbidity [ Time Frame: 30 days ]
    Any comoplications

  3. Mortality [ Time Frame: 30 day ]
    Mortality

  4. Changes in pancreatic endocrine function [ Time Frame: 6 Month ]
    Development or change in diabetes


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic pancreatitis
  • Failed medical treatment
  • Dilated pancreatic duct ( > 5mm)

Exclusion Criteria:

  • Age under 12 or more than 70 years
  • Pregnancy
  • Multiple (> 3) large stone (> 1.5 cm) in head of pancreas or stones present throughout head, body and tail

  • Contraindications to surgery

    • American Society of Anesthesiologists class IV
    • Portal hypertension

  • Contraindications to endoscopic treatment

    • Gastrectomy with Billroth II reconstruction
    • Other pancreatitis-related complications requiring surgery

  • Previous interventional therapy for chronic pancreatitis

    • Pancreatic endotherapy
    • Previous surgery
  • Suspected pancreatic cancer
  • Refusal to participate
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01520675


Locations
India
AIIMS
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Nikhil Agrawal, MS All India Institute of Medical Sciences, New Delhi
Study Director: T K Chattopadhyay All India Institute of Medical Sciences, New Delhi
Study Director: Peush Sahni All India Institute of Medical Sciences, New Delhi
Study Chair: Sujoy Pal All India Institute of Medical Sciences, New Delhi
Study Chair: N R Dash All India Institute of Medical Sciences, New Delhi
Study Director: Pramod Garg All India Institute of Medical Sciences, New Delhi
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Pramod Kumar Garg, Additional Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01520675     History of Changes
Other Study ID Numbers: IESC/T-187/2010
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017

Keywords provided by Pramod Kumar Garg, All India Institute of Medical Sciences, New Delhi:
chronic pancreatitis
randomized controlled trial
endoscopic therapy
surgery
ESWL

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases