Clinical trial NCT02510495: Effect of Endoscopic Papillary Balloon Dilation on ERCP Complications
Official title: Effect of Different Endoscopic Papillary Balloon Dilation Duration Time on Complications of Common Bile Duct Stone Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications
Keywords: Sphincterotomy
Dilatation
Common bile duct
Pancreatitis
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 1920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how different endoscopic papillary balloon dilatation (EPBD) duration time affects the complications after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of common bile duct stones.

Detailed description: Common bile duct (CBD) stone is a common disease with high morbidity. Half century ago, surgery with bile duct exploration and T-tube drainage was the only radical treatment for the stones until a revolutionary technique was reported in 1970, which possible to remove stone by means of endoscopic sphincterotomy (EST) during endoscopic retrograde cholangiopancreatography (ERCP). Since then, EST became a very promising measure for both patients and doctors to meet the purpose of minimally invasive treatment. However, EST remains an advanced technique which requires high skills of the endoscopist. As far as patients who have anatomical biliary abnormalities, such as papillary diverticulum, are more likely to end up with severe complications such as bleeding and perforation during EST procedure. On the other hand, EST may also lead to permanent dysfunction of the Oddi's sphincter. It is currently reported that a growing number of young patients, even some children are managed with EST which is still debated due to the existence of some long-term complications.

Endoscopic papillary balloon dilatation (EPBD) is an alternative technique developed to achieve the same purpose as EST but preserving Oddi's sphincter' function partially, and more than that, EPBD is easy to grasp for endoscopist. By using a columnar balloon, Oddi's sphincter can be expanded without direct transection, and the temporary relaxation of Oddi's sphincter makes it possible to remove the stones and the rest of the procedures as well. Removing common bile duct stone by EPBD was firstly reported in 1982 and proved to be safe and efficient. However, clinical observations have been found that simple EPBD has a higher incidence of developing acute pancreatitis after ERCP, especially in patients with intact papilla. The speculated reason for high post-ERCP pancreatitis (PEP) rate might be pancreatic duct orifice edema resulted from inadequate destroy of Oddi's sphincter during a balloon dilatation, leading the pancreatic duct obstructed and high ductal pressure afterward. Retrospective study has indicated the PEP rate of post-EPBD by 10% which was considered slightly higher than ordinary EST before a new modified method has been introduced by a small EST prior to EPBD. Currently small EST plus EPBD has been increasingly used in clinical and proven to be an effective treatment for improving the success rate of the common bile duct stone removal, preserving Oddi's sphincter function and lowering long-term complications.

Dedicate practitioners conducted many kinds of studies about reducing post-ERCP complications, and nowadays, some of them focus on the dilation time of EPBD which would be suspected as the key point of the issues. Nonetheless, more institutes are willing to join in EPBD research as the universal concerns for post-ERCP complications increases, no common agreements achieved at present.

From some prospected data, we might see confused results. Slowly inject balloon with a contrast agent and keep dilating for 1-2 minutes, until 15 seconds after the image of papilla and balloon waist disappeared is able to get the same stone removal rate as regular procedure does, and a slower balloon filling performance is helpful to protect the Oddi's sphincter function and reduce post-ERCP complications. However, other studies conclude there are no difference no matter in stone removal rate or post-ERCP pancreatitis instead of blood amylase, in which arms are 20 seconds compared 60 seconds and 30 seconds compared 60 seconds. Interestingly, there is another inspiring randomized controlled trial (RCT) study which prolong the dilation time up to 5 minutes. The author figured that PEP rate of five minutes group is smaller than that of the 1-minute group as well as stone removal.

Few studies concerning the optimal duration time of EPBD which is very important to patients' safety and maximum utilization of the easier handled EPBD procedure compared to EST. Therefore this large volume multicenter prospective randomize control study targets on how different EPBD duration management affect the complications after ERCP which attempts to discover a promising method for safe therapy in common bile duct stones.

Eligibility criteria: Inclusion Criteria:

* Age≥18 years
* CBD stone patients, stone diameter≤1.5cm, CBD diameter≤2cm

Exclusion Criteria:

* Unwillingness or inability to consent for the study
* Coagulation dysfunction (INR\> 1.3) and low peripheral blood platelet count (\<50×109 / L) or using anti-coagulation drugs
* Previous EST or EPBD
* Prior surgery of Bismuth Ⅱ and Roux-en-Y
* Benign or malignant CBD stricture
* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock
* Combined with Mirizzi syndrome and intrahepatic bile duct stones
* Malignant disease
* Biliary-duodenal fistula confirmed during ERCP
* Pregnant women

Primary outcomes:
measure: Post-ERCP pancreatitis
timeFrame: Within 7 days after ERCP
Secondary outcomes:
measure: Hemorrhage
timeFrame: Within 7 days after ERCP
measure: Perforation
timeFrame: Within 7 days after ERCP
measure: Acute cholangitis
timeFrame: Within 7 days after ERCP
measure: Pain
timeFrame: Within 7 days after ERCP
measure: Operation time
timeFrame: Up to 2 hours
measure: Average hospital stay
timeFrame: Up to 30 days
measure: Stone clearance rate
timeFrame: Up to 2 hours
measure: Success rate of stone extraction in the initial attempt
timeFrame: Up to 2 hours
measure: Rate of mechanical lithotripsy
timeFrame: Up to 2 hours
measure: X-ray exposure time
timeFrame: Up to 2 hours
measure: Pancreatic duct insertion times
timeFrame: Up to 2 hours
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Third Military Medical University
state: Chongqing
city: Lanzhou
country: China
facility: The first hospital of Lanzhou university
state: Gansu
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: Union hospital,Tongji medical collage,Huazhong University of science and technology
state: Hubei
city: Changsha
country: China
facility: Second Xiangya Hospital, Central South University
state: Hunan
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xian
country: China
facility: The first affiliated hospital of Xi 'an jiaotong university
state: Shaanxi
city: Jinan
country: China
facility: Shandong jiaotong Hospital
state: Shandong
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Taiyuan Iron and Steel Corporation Hospital
state: Shanxi
city: Ürümqi
country: China
facility: The First Teaching Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Xun Li, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Liao WC, Lee CT, Chang CY, Leung JW, Chen JH, Tsai MC, Lin JT, Wu MS, Wang HP. Randomized trial of 1-minute versus 5-minute endoscopic balloon dilation for extraction of bile duct stones. Gastrointest Endosc. 2010 Dec;72(6):1154-62. doi: 10.1016/j.gie.2010.07.009. Epub 2010 Sep 25.
citation: Meng W, Leung JW, 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. Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: a multicentre, single-blinded, randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Jun;4(6):425-434. doi: 10.1016/S2468-1253(19)30075-5. Epub 2019 Apr 16.