Effect of Endoscopic Papillary Balloon Dilation on ERCP Complications

Complications Clinical Trial

Official title:

Effect of Different Endoscopic Papillary Balloon Dilation Duration Time on Complications of Common Bile Duct Stone Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510495
• Other study ID #: ERCP Balloon Dilation
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 1, 2017

Study information

• Verified date: January 2019
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1920
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ? 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

Related Conditions & MeSH terms

• Complications

Intervention

Procedure:
• 30" group
A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 30 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.
• 60" group
A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 60 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.
• 180" group
A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 180 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.
• 300" group
A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 300 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin
China	Second Xiangya Hospital, Central South University	Changsha	Hunan
China	Third Military Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Shandong jiaotong Hospital	Jinan	Shandong
China	The first hospital of Lanzhou university	Lanzhou	Gansu
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Taiyuan Iron and Steel Corporation Hospital	Taiyuan	Shanxi
China	Tianjin Nankai Hospital	Tianjin
China	The First Teaching Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Union hospital,Tongji medical collage,Huazhong University of science and technology	Wuhan	Hubei
China	The first affiliated hospital of Xi 'an jiaotong university	Xian	Shaanxi
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (5)

Bang BW, Jeong S, Lee DH, Lee JI, Lee JW, Kwon KS, Kim HG, Shin YW, Kim YS. The ballooning time in endoscopic papillary balloon dilation for the treatment of bile duct stones. Korean J Intern Med. 2010 Sep;25(3):239-45. doi: 10.3904/kjim.2010.25.3.239. Epub 2010 Aug 31. — View 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. — View Citation

Meine GC, Baron TH. Endoscopic papillary large-balloon dilation combined with endoscopic biliary sphincterotomy for the removal of bile duct stones (with video). Gastrointest Endosc. 2011 Nov;74(5):1119-26; quiz 1115.e1-5. doi: 10.1016/j.gie.2011.06.042. Epub 2011 Sep 23. Review. — View Citation

Ozaslan E. Comment to "Sixty- versus thirty-seconds papillary balloon dilation after sphincterotomy for the treatment of large bile duct stones: a randomized controlled trial". Dig Liver Dis. 2013 Aug;45(8):700. doi: 10.1016/j.dld.2013.02.004. Epub 2013 Mar 13. — View Citation

Tsujino T, Kawabe T, Komatsu Y, Yoshida H, Isayama H, Sasaki T, Kogure H, Togawa O, Arizumi T, Matsubara S, Ito Y, Nakai Y, Yamamoto N, Sasahira N, Hirano K, Toda N, Tada M, Omata M. Endoscopic papillary balloon dilation for bile duct stone: immediate and long-term outcomes in 1000 patients. Clin Gastroenterol Hepatol. 2007 Jan;5(1):130-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ERCP pancreatitis	Upper abdominal pain with serum amylase elevation no less than 462 U/L after the procedure	Within 7 days after ERCP
Secondary	Hemorrhage	Maintained positive fecal occult blood test appears	Within 7 days after ERCP
Secondary	Perforation	CT scan shows retroperitoneal space fluid or gas	Within 7 days after ERCP
Secondary	Acute cholangitis	Intermittent chills and fever after ERCP	Within 7 days after ERCP
Secondary	Pain	Upper abdominal pain after ERCP measured by Numerical Rating Scale	Within 7 days after ERCP
Secondary	Operation time	From successful biliary intubation to end of operation	Up to 2 hours
Secondary	Average hospital stay	Length of stay in hospital	Up to 30 days
Secondary	Stone clearance rate	The proportion of patients with all stones removed	Up to 2 hours
Secondary	Success rate of stone extraction in the initial attempt	The proportion of patients with all stones removed in first attempt after EPBD	Up to 2 hours
Secondary	Rate of mechanical lithotripsy	The proportion of patients whose stones need mechanical lithotripsy before removed	Up to 2 hours
Secondary	X-ray exposure time	The total radiography time during ERCP	Up to 2 hours
Secondary	Pancreatic duct insertion times	Times of any accessories goes into the pancreatic duct, no matter how depth	Up to 2 hours