BACKGROUND: Non steroidal anti-inflammatory drugs (NSAIDs) have been shown to reduce the incidence of post endoscopic retrograde cholangiopancreatography pancreatitis (PEP). There were various trials using different routes and dosages of NSAIDs but meta-analysis revealed inconsistent results. AIMS: The aims of this study were to determine the efficacy of rectal diclofenac in preventing PEP and to evaluate any adverse events. METHODS: This was a randomized, open-label, two-arm, prospective clinical trial. Only patients at high risk of developing PEP were recruited. They received 100 mg rectal diclofenac or no intervention immediately after ERCP. The patients were reviewed 30 days after discharge to evaluate any adverse event. RESULTS: Among 144 recruited patients, 69 (47.9%) receiveddiclofenac and 75 (52.1%) had no intervention. Eleven patients (7.6%) developed PEP, in which seven were from the diclofenac group and four were in the control group. Eight cases of PEP (5.5%) were mild and three cases (2.1%) were moderate. The differences in pancreatitis incidence and severity between both groups were not statistically significant. There were 11 adverse events reported. Clinically significant bleeding happened in four patients (2.8%): one from the diclofenac group and three from the control group. Other events included cholangitis: two patients (2.9%) from the diclofenac group and four (5.3%) from the control group. One patient from the diclofenac group (1.4%) had a perforation which was treated conservatively. CONCLUSIONS: In summary, prophylactic rectal diclofenac did not significantly decrease the incidence of PEP among patients at high risk for developing PEP. However, the administration of diclofenac was fairly safe with few clinical adverse events.
RCT Entities:
BACKGROUND: Non steroidal anti-inflammatory drugs (NSAIDs) have been shown to reduce the incidence of post endoscopic retrograde cholangiopancreatography pancreatitis (PEP). There were various trials using different routes and dosages of NSAIDs but meta-analysis revealed inconsistent results. AIMS: The aims of this study were to determine the efficacy of rectal diclofenac in preventing PEP and to evaluate any adverse events. METHODS: This was a randomized, open-label, two-arm, prospective clinical trial. Only patients at high risk of developing PEP were recruited. They received 100 mg rectal diclofenac or no intervention immediately after ERCP. The patients were reviewed 30 days after discharge to evaluate any adverse event. RESULTS: Among 144 recruited patients, 69 (47.9%) received diclofenac and 75 (52.1%) had no intervention. Eleven patients (7.6%) developed PEP, in which seven were from the diclofenac group and four were in the control group. Eight cases of PEP (5.5%) were mild and three cases (2.1%) were moderate. The differences in pancreatitis incidence and severity between both groups were not statistically significant. There were 11 adverse events reported. Clinically significant bleeding happened in four patients (2.8%): one from the diclofenac group and three from the control group. Other events included cholangitis: two patients (2.9%) from the diclofenac group and four (5.3%) from the control group. One patient from the diclofenac group (1.4%) had a perforation which was treated conservatively. CONCLUSIONS: In summary, prophylactic rectal diclofenac did not significantly decrease the incidence of PEP among patients at high risk for developing PEP. However, the administration of diclofenac was fairly safe with few clinical adverse events.
Authors: Vilja Koskensalo; Andrea Tenca; Marianne Udd; Outi Lindström; Mia Rainio; Kalle Jokelainen; Leena Kylänpää; Martti Färkkilä Journal: United European Gastroenterol J Date: 2020-03-08 Impact factor: 4.623
Authors: Mohamed M Abdelfatah; Eric Gochanour; Nicholas J Koutlas; Ahmed Hamed; Glenn Harvin; Mohamed O Othman Journal: Ann Gastroenterol Date: 2020-05-15
Authors: Basile Njei; Thomas R McCarty; Thiruvengadam Muniraj; Prabin Sharma; Priya A Jamidar; Harry R Aslanian; Shyam Varadarajulu; Udayakumar Navaneethan Journal: Endosc Int Open Date: 2020-01-08