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

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 |

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
|
- Pain relief [ Time Frame: 1 year ]Relief in pain
- Quality of life [ Time Frame: 6 Month ]QoL score
- Morbidity [ Time Frame: 30 days ]Any comoplications
- Mortality [ Time Frame: 30 day ]Mortality
- Changes in pancreatic endocrine function [ Time Frame: 6 Month ]Development or change in diabetes

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 70 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
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

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
India | |
AIIMS | |
New Delhi, Delhi, India, 110029 |
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 |
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 |