AzTrials
AzTrials

ComplicationsNCT02510495

Effect of Endoscopic Papillary Balloon Dilation on ERCP Complications

A study testing 30" group, 60" group and 180" group in people with Complications, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Complications
What is being tested?
30" group, 60" group and 180" group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,920 participants
Where
15 sitesChina
Study dates
Feb 2016to 1 Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • Combined with Mirizzi syndrome and intrahepatic bile duct stones
  • Malignant disease
  • Biliary-duodenal fistula confirmed during ERCP
  • Pregnant women

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Second Xiangya Hospital, Central South University

    Changsha, Hunan, 410011

  • Third Military Medical University

    Chongqing, Chongqing Municipality, 400038

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Shandong jiaotong Hospital

    Jinan, Shandong, 250000

  • The first hospital of Lanzhou university

    Lanzhou, Gansu, 730000

  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Taiyuan Iron and Steel Corporation Hospital

    Taiyuan, Shanxi, 030008

  • Tianjin Nankai Hospital

    Tianjin, 300100

  • The First Teaching Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • Union hospital,Tongji medical collage,Huazhong University of science and technology

    Wuhan, Hubei, 430022

  • The first affiliated hospital of Xi 'an jiaotong university

    Xi'an, Shaanxi, 710061

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Complications
Being tested
30" group, 60" group, 180" group, 300" group
Keywords
Sphincterotomy, Dilatation, Common bile duct, Pancreatitis
Medical subject headings
Dilatation, Pathologic, Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 30" groupProcedure or surgery

    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" groupProcedure or surgery

    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" groupProcedure or surgery

    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" groupProcedure or surgery

    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.

Study groups in NCT02510495
Study groupRoleWhat they receive
0" groupNo interventionAfter a small sphincterotomy was performed, a controlled radial expansion (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 deflated immediately. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.
30" groupExperimentalAfter a small sphincterotomy was performed, a controlled radial expansion (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.
Receives: Procedure: 30" group
60" groupExperimentalAfter a small sphincterotomy was performed, a controlled radial expansion (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.
Receives: Procedure: 60" group
180" groupExperimentalAfter a small sphincterotomy was performed, a controlled radial expansion (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.
Receives: Procedure: 180" group
300" groupExperimentalAfter a small sphincterotomy was performed, a controlled radial expansion (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.
Receives: Procedure: 300" group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-ERCP pancreatitis

    Upper abdominal pain with serum amylase elevation no less than 462 U/L after the procedure

    Measured: Within 7 days after ERCP

Secondary outcomes (11)

  1. Hemorrhage

    Maintained positive fecal occult blood test appears

    Measured: Within 7 days after ERCP

  2. Perforation

    CT scan shows retroperitoneal space fluid or gas

    Measured: Within 7 days after ERCP

  3. Acute cholangitis

    Intermittent chills and fever after ERCP

    Measured: Within 7 days after ERCP

  4. Pain

    Upper abdominal pain after ERCP measured by Numerical Rating Scale

    Measured: Within 7 days after ERCP

  5. Operation time

    From successful biliary intubation to end of operation

    Measured: Up to 2 hours

  6. Average hospital stay

    Length of stay in hospital

    Measured: Up to 30 days

  7. Stone clearance rate

    The proportion of patients with all stones removed

    Measured: Up to 2 hours

  8. Success rate of stone extraction in the initial attempt

    The proportion of patients with all stones removed in first attempt after EPBD

    Measured: Up to 2 hours

  9. Rate of mechanical lithotripsy

    The proportion of patients whose stones need mechanical lithotripsy before removed

    Measured: Up to 2 hours

  10. X-ray exposure time

    The total radiography time during ERCP

    Measured: Up to 2 hours

  11. Pancreatic duct insertion times

    Times of any accessories goes into the pancreatic duct, no matter how depth

    Measured: Up to 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completion1 Nov 2017
  4. Study completion1 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,920 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02510495
Sponsor's protocol ID
ERCP Balloon Dilation
Status last verified
Jan 2019
First submitted
20 Jul 2015
Last updated
25 Jan 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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. No abstract available.

    PubMed 21944309

  • 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. doi: 10.1016/j.cgh.2006.10.013.

    PubMed 17234559

  • 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.

    PubMed 20830219

  • 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. No abstract available.

    PubMed 23490342

  • 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.

    PubMed 20869710

  • 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.

    PubMed 31003961

Questions about this trial

What is this clinical trial studying?

A study testing 30" group, 60" group and 180" group in people with Complications, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-ERCP pancreatitis (time frame: Within 7 days after ERCP). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02510495, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in