Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: a multicentre, single-blinded, randomised controlled trial

Wenbo Meng, Joseph Leung, Kai Zhang, Wence Zhou, Zhenyu Wang, Leida Zhang, Hao Sun, Ping Xue, Wei Liu, Qi Wang, Jijun Zhang, Xuefeng Wang, Meng Wang, Yingmei Shao, Kailin Cai, Senlin Hou, Qiyong Li, Lei Zhang, Kexiang Zhu, Ping YueHaiping Wang, Ming Zhang, Xiangyu Sun, Zhiqing Yang, Jie Tao, Zilong Wen, Qunwei Wang, Bendong Chen, Quan Shao, Mingning Zhao, Ruoyan Zhang, Tiemin Jiang, Ke Liu, Lichao Zhang, Kangjie Chen, Xiaoliang Zhu, Hui Zhang, Long Miao, Zhengfeng Wang, Jiajia Li, Xiaowen Yan, Fangzhao Wang, Lingen Zhang, Azumi Suzuki, Kiyohito Tanaka, Ula Nur, Elisabete Weiderpass, Xun Li

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Endoscopic sphincterotomy is the established treatment for common bile duct stones. Balloon dilation offers an alternative. Prolonged dilation (300 s) with a 10 mm diameter balloon decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). We aimed to determine the optimal duration of dilation for combined endoscopic sphincterotomy and balloon dilation for the removal of common bile duct stones. Methods: We did a multicentre, single-blinded, randomised controlled trial at 15 tertiary surgical centres in China. Eligible patients (≥18 years) with native papilla and common bile duct stones (≤1·5 cm in size and <2 cm in diameter) undergoing ERCP were randomly assigned (1:1:1:1:1) to receive balloon dilation for 0, 30, 60, 180, or 300 s after deep bile duct cannulation. Randomisation was done by an independent statistician using a computer-generated randomisation list with a block size of ten, stratified by centre. Patients and outcome assessors, but not endoscopists and investigators, were masked to treatment allocation. Balloon dilation was done with controlled radial expansion balloons according to common bile duct stone size. Stones were removed using stone retrieval balloons or baskets. The primary endpoint was overall frequency of post-ERCP pancreatitis. The primary efficacy analysis and safety analyses were done in the modified intention-to-treat population, which included all randomly assigned patients with successful cannulation, but excluded those who withdrew consent after randomisation. This study was registered with ClinicalTrials.gov, number NCT02510495, and is complete. Findings: Between July 29, 2015, and Dec 1, 2017, 3721 consecutive patients with common bile duct stones were recruited, 1718 of whom were excluded. The remaining 2003 patients underwent a small (3–5 mm) endoscopic sphincterotomy. 83 patients withdrew consent after the ERCP procedure, thus 1920 patients were included in the modified intention-to-treat analysis (0 s [n=371], 30 s [n=384], 60 s [n=388], 180 s [n=390], and 300 s [n=387]). Overall, post-ERCP pancreatitis occurred in 199 (10%) of 1920 patients (44 [12%] patients in the 0 s group, 28 [7%] in the 30 s group, 32 [8%] in the 60 s group, 36 [9%] in the 180 s group, and 59 [15%] in the 300 s group). Prolonged dilation (300 s) significantly increased the occurrence of post-ERCP pancreatitis compared with shorter balloon dilation (p=0·002). The frequency of post-ERCP pancreatitis was significantly lower in the 30, 60, and 180 s groups than in the 300 s group (relative risk [RR] 0·48, 95% CI 0·31–0·73; p=0·0005 vs the 30 s group; 0·54, 0·36–0·81; p=0·003 vs the 60 s group; 0·61, 0·41–0·89; p=0·01 vs the 180 s group). The frequency of post-ERCP pancreatitis was significantly higher in the 0 s group than the 30 s group (RR 1·62, 1·04–2·56; p=0·03). No difference in stone extraction (all ≥90%) was observed between groups. Following ERCP, 90 (5%) of 1920 patients had acute cholangitis, 14 (<1%) had acute cholecystitis, and five (<1%) had gastrointestinal bleeding, with no significant differences between groups. One (<1%) patient had Stapfer II perforation, which resolved spontaneously with conservative treatment. Interpretation: A balloon dilation time of 30 s for combined endoscopic sphincterotomy and balloon dilation reduced the frequency of post-ERCP pancreatitis and was determined to be the optimum dilation time for the removal of common bile duct stones. Funding: National Natural Science Foundation of China, Gansu Competitive Foundation Projects for Technology Development and Innovation.

Original languageEnglish (US)
Pages (from-to)425-434
Number of pages10
JournalThe Lancet Gastroenterology and Hepatology
Volume4
Issue number6
DOIs
StatePublished - Jun 1 2019

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Endoscopic Sphincterotomy
Common Bile Duct
Endoscopic Retrograde Cholangiopancreatography
Dilatation
Randomized Controlled Trials
Pancreatitis
Random Allocation
Catheterization
China
Natural Science Disciplines
Intention to Treat Analysis
Acute Cholecystitis
Cholangitis
Bile Ducts
Research Personnel

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones : a multicentre, single-blinded, randomised controlled trial. / Meng, Wenbo; Leung, Joseph; Zhang, Kai; Zhou, Wence; Wang, Zhenyu; Zhang, Leida; Sun, Hao; Xue, Ping; Liu, Wei; Wang, Qi; Zhang, Jijun; Wang, Xuefeng; Wang, Meng; Shao, Yingmei; Cai, Kailin; Hou, Senlin; Li, Qiyong; Zhang, Lei; Zhu, Kexiang; Yue, Ping; Wang, Haiping; Zhang, Ming; Sun, Xiangyu; Yang, Zhiqing; Tao, Jie; Wen, Zilong; Wang, Qunwei; Chen, Bendong; Shao, Quan; Zhao, Mingning; Zhang, Ruoyan; Jiang, Tiemin; Liu, Ke; Zhang, Lichao; Chen, Kangjie; Zhu, Xiaoliang; Zhang, Hui; Miao, Long; Wang, Zhengfeng; Li, Jiajia; Yan, Xiaowen; Wang, Fangzhao; Zhang, Lingen; Suzuki, Azumi; Tanaka, Kiyohito; Nur, Ula; Weiderpass, Elisabete; Li, Xun.

In: The Lancet Gastroenterology and Hepatology, Vol. 4, No. 6, 01.06.2019, p. 425-434.

Research output: Contribution to journalArticle

Meng, W, Leung, J, Zhang, K, Zhou, W, Wang, Z, Zhang, L, Sun, H, Xue, P, Liu, W, Wang, Q, Zhang, J, Wang, X, Wang, M, Shao, Y, Cai, K, Hou, S, Li, Q, Zhang, L, Zhu, K, Yue, P, Wang, H, Zhang, M, Sun, X, Yang, Z, Tao, J, Wen, Z, Wang, Q, Chen, B, Shao, Q, Zhao, M, Zhang, R, Jiang, T, Liu, K, Zhang, L, Chen, K, Zhu, X, Zhang, H, Miao, L, Wang, Z, Li, J, Yan, X, Wang, F, Zhang, L, Suzuki, A, Tanaka, K, Nur, U, Weiderpass, E & Li, X 2019, 'Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: a multicentre, single-blinded, randomised controlled trial', The Lancet Gastroenterology and Hepatology, vol. 4, no. 6, pp. 425-434. https://doi.org/10.1016/S2468-1253(19)30075-5
Meng, Wenbo ; Leung, Joseph ; Zhang, Kai ; Zhou, Wence ; Wang, Zhenyu ; Zhang, Leida ; Sun, Hao ; Xue, Ping ; Liu, Wei ; Wang, Qi ; Zhang, Jijun ; Wang, Xuefeng ; Wang, Meng ; Shao, Yingmei ; Cai, Kailin ; Hou, Senlin ; Li, Qiyong ; Zhang, Lei ; Zhu, Kexiang ; Yue, Ping ; Wang, Haiping ; Zhang, Ming ; Sun, Xiangyu ; Yang, Zhiqing ; Tao, Jie ; Wen, Zilong ; Wang, Qunwei ; Chen, Bendong ; Shao, Quan ; Zhao, Mingning ; Zhang, Ruoyan ; Jiang, Tiemin ; Liu, Ke ; Zhang, Lichao ; Chen, Kangjie ; Zhu, Xiaoliang ; Zhang, Hui ; Miao, Long ; Wang, Zhengfeng ; Li, Jiajia ; Yan, Xiaowen ; Wang, Fangzhao ; Zhang, Lingen ; Suzuki, Azumi ; Tanaka, Kiyohito ; Nur, Ula ; Weiderpass, Elisabete ; Li, Xun. / Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones : a multicentre, single-blinded, randomised controlled trial. In: The Lancet Gastroenterology and Hepatology. 2019 ; Vol. 4, No. 6. pp. 425-434.
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abstract = "Background: Endoscopic sphincterotomy is the established treatment for common bile duct stones. Balloon dilation offers an alternative. Prolonged dilation (300 s) with a 10 mm diameter balloon decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). We aimed to determine the optimal duration of dilation for combined endoscopic sphincterotomy and balloon dilation for the removal of common bile duct stones. Methods: We did a multicentre, single-blinded, randomised controlled trial at 15 tertiary surgical centres in China. Eligible patients (≥18 years) with native papilla and common bile duct stones (≤1·5 cm in size and <2 cm in diameter) undergoing ERCP were randomly assigned (1:1:1:1:1) to receive balloon dilation for 0, 30, 60, 180, or 300 s after deep bile duct cannulation. Randomisation was done by an independent statistician using a computer-generated randomisation list with a block size of ten, stratified by centre. Patients and outcome assessors, but not endoscopists and investigators, were masked to treatment allocation. Balloon dilation was done with controlled radial expansion balloons according to common bile duct stone size. Stones were removed using stone retrieval balloons or baskets. The primary endpoint was overall frequency of post-ERCP pancreatitis. The primary efficacy analysis and safety analyses were done in the modified intention-to-treat population, which included all randomly assigned patients with successful cannulation, but excluded those who withdrew consent after randomisation. This study was registered with ClinicalTrials.gov, number NCT02510495, and is complete. Findings: Between July 29, 2015, and Dec 1, 2017, 3721 consecutive patients with common bile duct stones were recruited, 1718 of whom were excluded. The remaining 2003 patients underwent a small (3–5 mm) endoscopic sphincterotomy. 83 patients withdrew consent after the ERCP procedure, thus 1920 patients were included in the modified intention-to-treat analysis (0 s [n=371], 30 s [n=384], 60 s [n=388], 180 s [n=390], and 300 s [n=387]). Overall, post-ERCP pancreatitis occurred in 199 (10{\%}) of 1920 patients (44 [12{\%}] patients in the 0 s group, 28 [7{\%}] in the 30 s group, 32 [8{\%}] in the 60 s group, 36 [9{\%}] in the 180 s group, and 59 [15{\%}] in the 300 s group). Prolonged dilation (300 s) significantly increased the occurrence of post-ERCP pancreatitis compared with shorter balloon dilation (p=0·002). The frequency of post-ERCP pancreatitis was significantly lower in the 30, 60, and 180 s groups than in the 300 s group (relative risk [RR] 0·48, 95{\%} CI 0·31–0·73; p=0·0005 vs the 30 s group; 0·54, 0·36–0·81; p=0·003 vs the 60 s group; 0·61, 0·41–0·89; p=0·01 vs the 180 s group). The frequency of post-ERCP pancreatitis was significantly higher in the 0 s group than the 30 s group (RR 1·62, 1·04–2·56; p=0·03). No difference in stone extraction (all ≥90{\%}) was observed between groups. Following ERCP, 90 (5{\%}) of 1920 patients had acute cholangitis, 14 (<1{\%}) had acute cholecystitis, and five (<1{\%}) had gastrointestinal bleeding, with no significant differences between groups. One (<1{\%}) patient had Stapfer II perforation, which resolved spontaneously with conservative treatment. Interpretation: A balloon dilation time of 30 s for combined endoscopic sphincterotomy and balloon dilation reduced the frequency of post-ERCP pancreatitis and was determined to be the optimum dilation time for the removal of common bile duct stones. Funding: National Natural Science Foundation of China, Gansu Competitive Foundation Projects for Technology Development and Innovation.",
author = "Wenbo Meng and Joseph Leung and Kai Zhang and Wence Zhou and Zhenyu Wang and Leida Zhang and Hao Sun and Ping Xue and Wei Liu and Qi Wang and Jijun Zhang and Xuefeng Wang and Meng Wang and Yingmei Shao and Kailin Cai and Senlin Hou and Qiyong Li and Lei Zhang and Kexiang Zhu and Ping Yue and Haiping Wang and Ming Zhang and Xiangyu Sun and Zhiqing Yang and Jie Tao and Zilong Wen and Qunwei Wang and Bendong Chen and Quan Shao and Mingning Zhao and Ruoyan Zhang and Tiemin Jiang and Ke Liu and Lichao Zhang and Kangjie Chen and Xiaoliang Zhu and Hui Zhang and Long Miao and Zhengfeng Wang and Jiajia Li and Xiaowen Yan and Fangzhao Wang and Lingen Zhang and Azumi Suzuki and Kiyohito Tanaka and Ula Nur and Elisabete Weiderpass and Xun Li",
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TY - JOUR

T1 - Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones

T2 - a multicentre, single-blinded, randomised controlled trial

AU - Meng, Wenbo

AU - Leung, Joseph

AU - Zhang, Kai

AU - Zhou, Wence

AU - Wang, Zhenyu

AU - Zhang, Leida

AU - Sun, Hao

AU - Xue, Ping

AU - Liu, Wei

AU - Wang, Qi

AU - Zhang, Jijun

AU - Wang, Xuefeng

AU - Wang, Meng

AU - Shao, Yingmei

AU - Cai, Kailin

AU - Hou, Senlin

AU - Li, Qiyong

AU - Zhang, Lei

AU - Zhu, Kexiang

AU - Yue, Ping

AU - Wang, Haiping

AU - Zhang, Ming

AU - Sun, Xiangyu

AU - Yang, Zhiqing

AU - Tao, Jie

AU - Wen, Zilong

AU - Wang, Qunwei

AU - Chen, Bendong

AU - Shao, Quan

AU - Zhao, Mingning

AU - Zhang, Ruoyan

AU - Jiang, Tiemin

AU - Liu, Ke

AU - Zhang, Lichao

AU - Chen, Kangjie

AU - Zhu, Xiaoliang

AU - Zhang, Hui

AU - Miao, Long

AU - Wang, Zhengfeng

AU - Li, Jiajia

AU - Yan, Xiaowen

AU - Wang, Fangzhao

AU - Zhang, Lingen

AU - Suzuki, Azumi

AU - Tanaka, Kiyohito

AU - Nur, Ula

AU - Weiderpass, Elisabete

AU - Li, Xun

PY - 2019/6/1

Y1 - 2019/6/1

N2 - Background: Endoscopic sphincterotomy is the established treatment for common bile duct stones. Balloon dilation offers an alternative. Prolonged dilation (300 s) with a 10 mm diameter balloon decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). We aimed to determine the optimal duration of dilation for combined endoscopic sphincterotomy and balloon dilation for the removal of common bile duct stones. Methods: We did a multicentre, single-blinded, randomised controlled trial at 15 tertiary surgical centres in China. Eligible patients (≥18 years) with native papilla and common bile duct stones (≤1·5 cm in size and <2 cm in diameter) undergoing ERCP were randomly assigned (1:1:1:1:1) to receive balloon dilation for 0, 30, 60, 180, or 300 s after deep bile duct cannulation. Randomisation was done by an independent statistician using a computer-generated randomisation list with a block size of ten, stratified by centre. Patients and outcome assessors, but not endoscopists and investigators, were masked to treatment allocation. Balloon dilation was done with controlled radial expansion balloons according to common bile duct stone size. Stones were removed using stone retrieval balloons or baskets. The primary endpoint was overall frequency of post-ERCP pancreatitis. The primary efficacy analysis and safety analyses were done in the modified intention-to-treat population, which included all randomly assigned patients with successful cannulation, but excluded those who withdrew consent after randomisation. This study was registered with ClinicalTrials.gov, number NCT02510495, and is complete. Findings: Between July 29, 2015, and Dec 1, 2017, 3721 consecutive patients with common bile duct stones were recruited, 1718 of whom were excluded. The remaining 2003 patients underwent a small (3–5 mm) endoscopic sphincterotomy. 83 patients withdrew consent after the ERCP procedure, thus 1920 patients were included in the modified intention-to-treat analysis (0 s [n=371], 30 s [n=384], 60 s [n=388], 180 s [n=390], and 300 s [n=387]). Overall, post-ERCP pancreatitis occurred in 199 (10%) of 1920 patients (44 [12%] patients in the 0 s group, 28 [7%] in the 30 s group, 32 [8%] in the 60 s group, 36 [9%] in the 180 s group, and 59 [15%] in the 300 s group). Prolonged dilation (300 s) significantly increased the occurrence of post-ERCP pancreatitis compared with shorter balloon dilation (p=0·002). The frequency of post-ERCP pancreatitis was significantly lower in the 30, 60, and 180 s groups than in the 300 s group (relative risk [RR] 0·48, 95% CI 0·31–0·73; p=0·0005 vs the 30 s group; 0·54, 0·36–0·81; p=0·003 vs the 60 s group; 0·61, 0·41–0·89; p=0·01 vs the 180 s group). The frequency of post-ERCP pancreatitis was significantly higher in the 0 s group than the 30 s group (RR 1·62, 1·04–2·56; p=0·03). No difference in stone extraction (all ≥90%) was observed between groups. Following ERCP, 90 (5%) of 1920 patients had acute cholangitis, 14 (<1%) had acute cholecystitis, and five (<1%) had gastrointestinal bleeding, with no significant differences between groups. One (<1%) patient had Stapfer II perforation, which resolved spontaneously with conservative treatment. Interpretation: A balloon dilation time of 30 s for combined endoscopic sphincterotomy and balloon dilation reduced the frequency of post-ERCP pancreatitis and was determined to be the optimum dilation time for the removal of common bile duct stones. Funding: National Natural Science Foundation of China, Gansu Competitive Foundation Projects for Technology Development and Innovation.

AB - Background: Endoscopic sphincterotomy is the established treatment for common bile duct stones. Balloon dilation offers an alternative. Prolonged dilation (300 s) with a 10 mm diameter balloon decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). We aimed to determine the optimal duration of dilation for combined endoscopic sphincterotomy and balloon dilation for the removal of common bile duct stones. Methods: We did a multicentre, single-blinded, randomised controlled trial at 15 tertiary surgical centres in China. Eligible patients (≥18 years) with native papilla and common bile duct stones (≤1·5 cm in size and <2 cm in diameter) undergoing ERCP were randomly assigned (1:1:1:1:1) to receive balloon dilation for 0, 30, 60, 180, or 300 s after deep bile duct cannulation. Randomisation was done by an independent statistician using a computer-generated randomisation list with a block size of ten, stratified by centre. Patients and outcome assessors, but not endoscopists and investigators, were masked to treatment allocation. Balloon dilation was done with controlled radial expansion balloons according to common bile duct stone size. Stones were removed using stone retrieval balloons or baskets. The primary endpoint was overall frequency of post-ERCP pancreatitis. The primary efficacy analysis and safety analyses were done in the modified intention-to-treat population, which included all randomly assigned patients with successful cannulation, but excluded those who withdrew consent after randomisation. This study was registered with ClinicalTrials.gov, number NCT02510495, and is complete. Findings: Between July 29, 2015, and Dec 1, 2017, 3721 consecutive patients with common bile duct stones were recruited, 1718 of whom were excluded. The remaining 2003 patients underwent a small (3–5 mm) endoscopic sphincterotomy. 83 patients withdrew consent after the ERCP procedure, thus 1920 patients were included in the modified intention-to-treat analysis (0 s [n=371], 30 s [n=384], 60 s [n=388], 180 s [n=390], and 300 s [n=387]). Overall, post-ERCP pancreatitis occurred in 199 (10%) of 1920 patients (44 [12%] patients in the 0 s group, 28 [7%] in the 30 s group, 32 [8%] in the 60 s group, 36 [9%] in the 180 s group, and 59 [15%] in the 300 s group). Prolonged dilation (300 s) significantly increased the occurrence of post-ERCP pancreatitis compared with shorter balloon dilation (p=0·002). The frequency of post-ERCP pancreatitis was significantly lower in the 30, 60, and 180 s groups than in the 300 s group (relative risk [RR] 0·48, 95% CI 0·31–0·73; p=0·0005 vs the 30 s group; 0·54, 0·36–0·81; p=0·003 vs the 60 s group; 0·61, 0·41–0·89; p=0·01 vs the 180 s group). The frequency of post-ERCP pancreatitis was significantly higher in the 0 s group than the 30 s group (RR 1·62, 1·04–2·56; p=0·03). No difference in stone extraction (all ≥90%) was observed between groups. Following ERCP, 90 (5%) of 1920 patients had acute cholangitis, 14 (<1%) had acute cholecystitis, and five (<1%) had gastrointestinal bleeding, with no significant differences between groups. One (<1%) patient had Stapfer II perforation, which resolved spontaneously with conservative treatment. Interpretation: A balloon dilation time of 30 s for combined endoscopic sphincterotomy and balloon dilation reduced the frequency of post-ERCP pancreatitis and was determined to be the optimum dilation time for the removal of common bile duct stones. Funding: National Natural Science Foundation of China, Gansu Competitive Foundation Projects for Technology Development and Innovation.

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