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Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial.
Lancet 2016; 387(10035):2293-2301Lct

Abstract

BACKGROUND

Rectal indometacin decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, the population most at risk and the optimal timing of administration require further investigation. We aimed to assess whether pre-procedural administration of rectal indometacin in all patients is more effective than post-procedural use in only high-risk patients to prevent post-ERCP pancreatitis.

METHODS

We did a multicentre, single-blinded, randomised controlled trial at six centres in China. Eligible patients with native papilla undergoing ERCP were randomly assigned in a 1:1 ratio (with a computer-generated list) to universal pre-procedural indometacin or post-procedural indometacin in only high-risk patients, with stratification by trial centres and block size of ten. In the universal indometacin group, all patients received a single dose (100 mg) of rectal indometacin within 30 min before ERCP. In the risk-stratified, post-procedural indometacin group, only patients at predicted high risk received rectal indometacin, immediately after ERCP. Investigators, but not patients, were masked to group allocation. The primary outcome was overall ocurrence of post-ERCP pancreatitis. The analysis followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT02002650.

FINDINGS

Between Dec 15, 2013, and Sept 21, 2015, 2600 patients were randomly assigned to universal, pre-procedural indometacin (n=1297) or risk-stratified, post-procedural indometacin (n=1303). Overall, post-ERCP pancreatitis occurred in 47 (4%) of 1297 patients assigned to universal indometacin and 100 (8%) of 1303 patients assigned to risk-stratified indometacin (relative risk 0·47; 95% CI 0·34-0·66; p<0·0001). Post-ERCP pancreatitis occurred in 18 (6%) of 305 high-risk patients in the universal group and 35 (12%) of 281 high-risk patients in the risk-stratified group (p=0·0057). Post-ERCP pancreatitis was also less frequent in average-risk patients in the universal group (3% [29/992]), in which they received indometacin, than in the risk-stratified group (6% [65/1022]), in which they did not receive the drug (p=0·0003). Other than pancreatitis, adverse events occurred in 41 (3%; two severe) patients in the universal indometacin group and 48 (4%; one severe) patients in the risk-stratified group. The most common adverse events were biliary infection (22 [2%] patients vs 33 [3%] patients) and gastrointestinal bleeding (13 [1%] vs ten [1%]).

INTERPRETATION

Compared with a risk-stratified, post-procedural strategy, pre-procedural administration of rectal indometacin in unselected patients reduced the overall occurrence of post-ERCP pancreatitis without increasing risk of bleeding. Our results favour the routine use of rectal indometacin in patients without contraindications before ERCP.

FUNDING

National Key Technology R&D Program, National Natural Science Foundation of China.

Authors+Show Affiliations

Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.Department of Radiotherapy, Xijing Hospital, Fourth Military Medical University, Xi'an, China.Gastroenterology, Sacramento VA Medical Center, VANCHCS, Mather, and UC Davis Medical Center, Sacramento, CA, USA.Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region, Urumqi, China.Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region, Urumqi, China.The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China.The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China.The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China.Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.Department of Gastroenterology, No 451 Military Hospital, Xi'an, China.Department of Gastroenterology, No 451 Military Hospital, Xi'an, China.Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China. Electronic address: yanglinpan@hotmail.com.Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China. Electronic address: xuegangguo@gmail.com.Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.

Pub Type(s)

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

Language

eng

PubMed ID

27133971

Citation

Luo, Hui, et al. "Routine Pre-procedural Rectal Indometacin Versus Selective Post-procedural Rectal Indometacin to Prevent Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: a Multicentre, Single-blinded, Randomised Controlled Trial." Lancet (London, England), vol. 387, no. 10035, 2016, pp. 2293-2301.
Luo H, Zhao L, Leung J, et al. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet. 2016;387(10035):2293-2301.
Luo, H., Zhao, L., Leung, J., Zhang, R., Liu, Z., Wang, X., ... Fan, D. (2016). Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet (London, England), 387(10035), pp. 2293-2301. doi:10.1016/S0140-6736(16)30310-5.
Luo H, et al. Routine Pre-procedural Rectal Indometacin Versus Selective Post-procedural Rectal Indometacin to Prevent Pancreatitis in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: a Multicentre, Single-blinded, Randomised Controlled Trial. Lancet. 2016 Jun 4;387(10035):2293-2301. PubMed PMID: 27133971.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. AU - Luo,Hui, AU - Zhao,Lina, AU - Leung,Joseph, AU - Zhang,Rongchun, AU - Liu,Zhiguo, AU - Wang,Xiangping, AU - Wang,Biaoluo, AU - Nie,Zhanguo, AU - Lei,Ting, AU - Li,Xun, AU - Zhou,Wence, AU - Zhang,Lingen, AU - Wang,Qi, AU - Li,Ming, AU - Zhou,Yi, AU - Liu,Qian, AU - Sun,Hao, AU - Wang,Zheng, AU - Liang,Shuhui, AU - Guo,Xiaoyang, AU - Tao,Qin, AU - Wu,Kaichun, AU - Pan,Yanglin, AU - Guo,Xuegang, AU - Fan,Daiming, Y1 - 2016/04/28/ PY - 2016/5/3/entrez PY - 2016/5/3/pubmed PY - 2016/6/28/medline SP - 2293 EP - 2301 JF - Lancet (London, England) JO - Lancet VL - 387 IS - 10035 N2 - BACKGROUND: Rectal indometacin decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, the population most at risk and the optimal timing of administration require further investigation. We aimed to assess whether pre-procedural administration of rectal indometacin in all patients is more effective than post-procedural use in only high-risk patients to prevent post-ERCP pancreatitis. METHODS: We did a multicentre, single-blinded, randomised controlled trial at six centres in China. Eligible patients with native papilla undergoing ERCP were randomly assigned in a 1:1 ratio (with a computer-generated list) to universal pre-procedural indometacin or post-procedural indometacin in only high-risk patients, with stratification by trial centres and block size of ten. In the universal indometacin group, all patients received a single dose (100 mg) of rectal indometacin within 30 min before ERCP. In the risk-stratified, post-procedural indometacin group, only patients at predicted high risk received rectal indometacin, immediately after ERCP. Investigators, but not patients, were masked to group allocation. The primary outcome was overall ocurrence of post-ERCP pancreatitis. The analysis followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT02002650. FINDINGS: Between Dec 15, 2013, and Sept 21, 2015, 2600 patients were randomly assigned to universal, pre-procedural indometacin (n=1297) or risk-stratified, post-procedural indometacin (n=1303). Overall, post-ERCP pancreatitis occurred in 47 (4%) of 1297 patients assigned to universal indometacin and 100 (8%) of 1303 patients assigned to risk-stratified indometacin (relative risk 0·47; 95% CI 0·34-0·66; p<0·0001). Post-ERCP pancreatitis occurred in 18 (6%) of 305 high-risk patients in the universal group and 35 (12%) of 281 high-risk patients in the risk-stratified group (p=0·0057). Post-ERCP pancreatitis was also less frequent in average-risk patients in the universal group (3% [29/992]), in which they received indometacin, than in the risk-stratified group (6% [65/1022]), in which they did not receive the drug (p=0·0003). Other than pancreatitis, adverse events occurred in 41 (3%; two severe) patients in the universal indometacin group and 48 (4%; one severe) patients in the risk-stratified group. The most common adverse events were biliary infection (22 [2%] patients vs 33 [3%] patients) and gastrointestinal bleeding (13 [1%] vs ten [1%]). INTERPRETATION: Compared with a risk-stratified, post-procedural strategy, pre-procedural administration of rectal indometacin in unselected patients reduced the overall occurrence of post-ERCP pancreatitis without increasing risk of bleeding. Our results favour the routine use of rectal indometacin in patients without contraindications before ERCP. FUNDING: National Key Technology R&D Program, National Natural Science Foundation of China. SN - 1474-547X UR - https://www.unboundmedicine.com/medline/citation/27133971/Routine_pre_procedural_rectal_indometacin_versus_selective_post_procedural_rectal_indometacin_to_prevent_pancreatitis_in_patients_undergoing_endoscopic_retrograde_cholangiopancreatography:_a_multicentre_single_blinded_randomised_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(16)30310-5 DB - PRIME DP - Unbound Medicine ER -