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Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial.
BMC Gastroenterol. 2015 Jul 21; 15:85.BG

Abstract

BACKGROUND

Acute pancreatitis is the most common major complication after endoscopic retrograde cholangiopancreatography (ERCP). Many drugs have been evaluated for prophylaxis, including nonsteroidal anti-inflammatory drugs (NSAIDs), which are potent inhibitors of phospholipase A2 and play a role in the pathogenesis of acute pancreatitis. Rectal NSAIDs have been shown in prospective studies to decrease the incidence of this complication, but the indication is not generalized in clinical practice. The aim of this study was to evaluate the efficacy of rectal administration of indomethacin in reducing the incidence of post-ERCP pancreatitis in high-risk patients.

METHODS

This was a controlled clinical trial where patients with an elevated risk of developing post-ERCP pancreatitis were assigned to receive 100 mg of rectal indomethacin or a 2.6 g suppository of glycerin immediately after ERCP, without placement of a pancreatic stent. The patients were determined to be at high risk based on validated patient- and procedure-related risk factors. Post-ERCP pancreatitis was defined as the presence of new upper abdominal pain, hyperamylasemia/hyperlipasemia (at least three times the upper limit) 2 hours after the procedure and hospitalization at least 48 hours because of the complication. Pancreatitis severity was defined according to Cotton's criteria.

RESULTS

One hundred sixty-six patients were included; 82 in the study group and 84 in the placebo group. Patients had at least one major and/or two minor risk factors for developing post-ERCP pancreatitis. The incidence of the complication was 4.87% (4/82) in the study group and 20.23% (17/84) in the placebo group; this difference was significant (P = 0.01). According to Cotton's criteria, 17 patients (80.9%) developed mild pancreatitis and 4 (19.1%) had moderate pancreatitis; 3 of these 4 patients belonged to the placebo group (P = 0.60). Based on these results, an absolute risk reduction of 0.15 (15%), a relative risk reduction of 0.75 (75%) and a number needed to treat of 6.5 patients were calculated to prevent an episode of post-ERCP pancreatitis. There was no mortality.

CONCLUSIONS

Rectal indomethacin reduced the incidence of post-ERCP pancreatitis among patients at high risk of developing this complication.

TRIAL REGISTRATION

National Clinical Trials NCT02110810. Date April 7, 2014.

Authors+Show Affiliations

Department Gastrointestinal Endoscopy, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, México. avygail@terra.com.mx.Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México. ln.marianachavez@gmail.com.Department Gastrointestinal Endoscopy, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, México. cdavaloscobian@yahoo.com.mx.Department Gastrointestinal Endoscopy, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, México. uieccirugia@gmail.com.Department Gastrointestinal Endoscopy, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, México. compa07@gmail.com.Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México. clotilde.fuentes@gmail.com.Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México. mikedassaejv@gmail.com.Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México. md.jesus.garcia@gmail.com.Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México. jorefe12@gmail.com.Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México. jaclmed@hotmail.com.Department of Pediatric Surgery, Children's Hospital of the Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, México. ggaby03@yahoo.com.Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México. anacortes29@hotmail.com.Health Research Coordination, Mexican Institute of Social Security, Baja California Sur, Mexico. andrea_surgery@hotmail.com.Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México. avygail5@yahoo.com.mx.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26195123

Citation

Andrade-Dávila, Víctor Fernando, et al. "Rectal Indomethacin Versus Placebo to Reduce the Incidence of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: Results of a Controlled Clinical Trial." BMC Gastroenterology, vol. 15, 2015, p. 85.
Andrade-Dávila VF, Chávez-Tostado M, Dávalos-Cobián C, et al. Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial. BMC Gastroenterol. 2015;15:85.
Andrade-Dávila, V. F., Chávez-Tostado, M., Dávalos-Cobián, C., García-Correa, J., Montaño-Loza, A., Fuentes-Orozco, C., Macías-Amezcua, M. D., García-Rentería, J., Rendón-Félix, J., Cortés-Lares, J. A., Ambriz-González, G., Cortés-Flores, A. O., Alvarez-Villaseñor, A. d. e. l. . S., & González-Ojeda, A. (2015). Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial. BMC Gastroenterology, 15, 85. https://doi.org/10.1186/s12876-015-0314-2
Andrade-Dávila VF, et al. Rectal Indomethacin Versus Placebo to Reduce the Incidence of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: Results of a Controlled Clinical Trial. BMC Gastroenterol. 2015 Jul 21;15:85. PubMed PMID: 26195123.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial. AU - Andrade-Dávila,Víctor Fernando, AU - Chávez-Tostado,Mariana, AU - Dávalos-Cobián,Carlos, AU - García-Correa,Jesús, AU - Montaño-Loza,Alejandro, AU - Fuentes-Orozco,Clotilde, AU - Macías-Amezcua,Michel Dassaejv, AU - García-Rentería,Jesús, AU - Rendón-Félix,Jorge, AU - Cortés-Lares,José Antonio, AU - Ambriz-González,Gabriela, AU - Cortés-Flores,Ana Olivia, AU - Alvarez-Villaseñor,Andrea del Socorro, AU - González-Ojeda,Alejandro, Y1 - 2015/07/21/ PY - 2014/12/29/received PY - 2015/07/08/accepted PY - 2015/7/22/entrez PY - 2015/7/22/pubmed PY - 2016/5/14/medline SP - 85 EP - 85 JF - BMC gastroenterology JO - BMC Gastroenterol VL - 15 N2 - BACKGROUND: Acute pancreatitis is the most common major complication after endoscopic retrograde cholangiopancreatography (ERCP). Many drugs have been evaluated for prophylaxis, including nonsteroidal anti-inflammatory drugs (NSAIDs), which are potent inhibitors of phospholipase A2 and play a role in the pathogenesis of acute pancreatitis. Rectal NSAIDs have been shown in prospective studies to decrease the incidence of this complication, but the indication is not generalized in clinical practice. The aim of this study was to evaluate the efficacy of rectal administration of indomethacin in reducing the incidence of post-ERCP pancreatitis in high-risk patients. METHODS: This was a controlled clinical trial where patients with an elevated risk of developing post-ERCP pancreatitis were assigned to receive 100 mg of rectal indomethacin or a 2.6 g suppository of glycerin immediately after ERCP, without placement of a pancreatic stent. The patients were determined to be at high risk based on validated patient- and procedure-related risk factors. Post-ERCP pancreatitis was defined as the presence of new upper abdominal pain, hyperamylasemia/hyperlipasemia (at least three times the upper limit) 2 hours after the procedure and hospitalization at least 48 hours because of the complication. Pancreatitis severity was defined according to Cotton's criteria. RESULTS: One hundred sixty-six patients were included; 82 in the study group and 84 in the placebo group. Patients had at least one major and/or two minor risk factors for developing post-ERCP pancreatitis. The incidence of the complication was 4.87% (4/82) in the study group and 20.23% (17/84) in the placebo group; this difference was significant (P = 0.01). According to Cotton's criteria, 17 patients (80.9%) developed mild pancreatitis and 4 (19.1%) had moderate pancreatitis; 3 of these 4 patients belonged to the placebo group (P = 0.60). Based on these results, an absolute risk reduction of 0.15 (15%), a relative risk reduction of 0.75 (75%) and a number needed to treat of 6.5 patients were calculated to prevent an episode of post-ERCP pancreatitis. There was no mortality. CONCLUSIONS: Rectal indomethacin reduced the incidence of post-ERCP pancreatitis among patients at high risk of developing this complication. TRIAL REGISTRATION: National Clinical Trials NCT02110810. Date April 7, 2014. SN - 1471-230X UR - https://www.unboundmedicine.com/medline/citation/26195123/Rectal_indomethacin_versus_placebo_to_reduce_the_incidence_of_pancreatitis_after_endoscopic_retrograde_cholangiopancreatography:_results_of_a_controlled_clinical_trial_ L2 - https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-015-0314-2 DB - PRIME DP - Unbound Medicine ER -