Endoscopic Versus Surgical Treatment of Chronic Pancreatitis
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Purpose
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 | Intervention |
|---|---|
|
Chronic Pancreatitis |
Procedure: surgery Procedure: Endoscopic therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Endoscopic Versus Surgical Treatment of Chronic Pancreatitis - A Randomized Controlled Trial |
- Pain relief [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 6 Month ] [ Designated as safety issue: No ]
- Morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 30 day ] [ Designated as safety issue: No ]
- Changes in pancreatic endocrine function [ Time Frame: 6 Month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 12 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Pramod Garg, MS | +919868397205 | pgarg10@gmail.com |
| India | |
| AIIMS | Recruiting |
| New Delhi, Delhi, India, 110029 | |
| Contact: Pramod Garg +919868397205 pgarg10@gmail.com | |
| 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
No publications provided
| 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 |
| Study First Received: | January 19, 2012 |
| Last Updated: | August 31, 2012 |
| Health Authority: | India: Ministry of Health |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on May 16, 2013