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All patients signed informed consents for the procedure, and the participation in the study.
Between June 2012 and June 2013, 199 patients fulfilled the inclusion criteria, 182 of whom were included in the final analysis.
Patients were excluded from study participation if they had a contraindication for diclofenac, including patients with recently diagnosed peptic ulcer disease, renal failure, those who developed acute pancreatitis during the two weeks before ERCP, those with a history of chronic pancreatitis, and those who did not agree to participate in the study.
A placebo-controlled trial was conducted in 182 patients who underwent ERCP.
Preoperative, the patients received 75 mg intramuscular(IM) diclofenac or IM normal saline as placebo. At the end of each procedure, the investigators recorded the details of the maneuvers performed, including:
Serum amylase was determined 12 hours after ERCP.
Statistical analysis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac,75 mg, 3 ml, | Active Comparator | patients were given Diclofenac IM before ERCP. |
|
| Normal Saline, 3ml, IM | Placebo Comparator | patients were given normal saline 3 ml before ERCP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP | Procedure | endoscopy, retrograde cholangio-pancreaticography. |
|
| Measure | Description | Time Frame |
|---|---|---|
| prevention of pancreatitis, |
| within a week after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasser Abu-Safieh, MD, AGAF | Specialized Arab Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SAH hospital | Nablus | West Bank | 970 | Palestinian Territories |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| C064142 | diclofenac hydroxyethylpyrrolidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| Diclofenac hydroxyethylpyrrolidine | Drug |
|
| Normal Saline | Drug |
|
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |