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Endoscopic retrograde cholangiopancreatography (ERCP) is a key procedure for managing biliopancreatic diseases, although it is associated with complications such as post-ERCP pancreatitis. This study assessed the efficacy of a prophylactic protocol combining rectal indomethacin with aggressive hydration to reduce the incidence of post-ERCP pancreatitis and serum amylase and lipase levels.
A randomized controlled trial was conducted with 60 patients undergoing ERCP at a secondary-care teaching public hospital. Patients were divided into two groups: With and without prophylaxis. Differences in post-ERCP pancreatitis incidence and pancreatic enzyme levels before and after the procedure were analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | The control group underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) without prophylactic treatment | |
| Prophylaxis Group | Experimental | The prophylaxis group received 100 mg of rectal indomethacin 30 minutes before the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, combined with intravenous Hartmann's solution administered at 3 mL/kg/hr during the procedure, plus a 20 mL/kg bolus given post-procedure, followed by continuous hydration at 3 mL/kg/hr for 8 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal Indometacin | Drug | The gold standard for treating diseases affecting the biliopancreatic ducts, choledocholithiasis being the most common indication, for which sphincterotomy is the most frequently performed procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-ERCP pancreatitis | Pancreas inflammation after the ERCP procedure | From the end of the ERCP procedure through 24 hours |
| Post-ERCP pancreatitis | Pancreas inflammation due to the ERCP procedure | Ocurring in the first 24 hours posterior to the ERCP |
| Measure | Description | Time Frame |
|---|---|---|
| Post-ERCP Pancreatic enzyme elevation | Elevation of the amylase and/or lipase after the ERCP procedure | Ocurring in the first 24 hours posterior to the ERCP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rubén Cuevas-MartÃnez, MD, MSc | Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo" | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo" | Chihuahua City | Chihuahua | 31000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33585008 | Background | Aghajanpoor Pasha M, Eslami P, Dooghaie Moghadam A, Moazzami B, Shojaee S, Almasi F, Tavakolikia N, Norouzinia M, Radinnia E, Sadeghi A. The synergistic impact of NSAIDs and aggressive hydration therapy on the rate of post-ERCP pancreatitis in high -risk and low -risk patients. Gastroenterol Hepatol Bed Bench. 2020 Winter;13(Suppl1):S81-S88. | |
| 34109084 |
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Out of respect for Mexican legislation regarding the confidentiality of information of private individuals
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2026 | May 11, 2026 | Prot_SAP_000.pdf |
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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 |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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To determine if a prophylactic dose of rectal indomethacin plus an aggressive hydration scheme reduces the incidence of post-ERCP pancreatitis, a randomized controlled study (RCT) was designed in the surgery department of a secondary-care teaching hospital.
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|
| Aljohani S, Mirghani H. Aggressive Hydration With Ringer's Lactate in the Prevention of Post-ERCP Pancreatitis: A Meta-Analysis. Cureus. 2021 May 7;13(5):e14897. doi: 10.7759/cureus.14897. |
| 28298192 | Background | Wan J, Ren Y, Zhu Z, Xia L, Lu N. How to select patients and timing for rectal indomethacin to prevent post-ERCP pancreatitis: a systematic review and meta-analysis. BMC Gastroenterol. 2017 Mar 15;17(1):43. doi: 10.1186/s12876-017-0599-4. |
| 35845027 | Background | Goyal H, Sachdeva S, Sherazi SAA, Gupta S, Perisetti A, Ali A, Chandan S, Tharian B, Sharma N, Thosani N. Early prediction of post-ERCP pancreatitis by post-procedure amylase and lipase levels: A systematic review and meta-analysis. Endosc Int Open. 2022 Jul 15;10(7):E952-E970. doi: 10.1055/a-1793-9508. eCollection 2022 Jul. |
| 36143938 | Background | Cahyadi O, Tehami N, de-Madaria E, Siau K. Post-ERCP Pancreatitis: Prevention, Diagnosis and Management. Medicina (Kaunas). 2022 Sep 12;58(9):1261. doi: 10.3390/medicina58091261. |
| 33740414 | Background | Easler JJ, Fogel EL. Prevention of post-ERCP pancreatitis: the search continues. Lancet Gastroenterol Hepatol. 2021 May;6(5):336-337. doi: 10.1016/S2468-1253(21)00063-7. Epub 2021 Mar 19. No abstract available. |
| 36895283 | Background | Borrelli de Andreis F, Mascagni P, Schepis T, Attili F, Tringali A, Costamagna G, Boskoski I. Prevention of post-ERCP pancreatitis: current strategies and novel perspectives. Ther Adv Gastroenterol. 2023 Mar 6;16:17562848231155984. doi: 10.1177/17562848231155984. eCollection 2023. |
| 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 |