Effect of Endoscopic Papillary Balloon Dilation on ERCP Complications

NACompletedINTERVENTIONAL
Enrollment

1,920

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

November 1, 2017

Study Completion Date

November 1, 2017

Conditions
Complications
Interventions
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.

PROCEDURE

"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.

PROCEDURE

"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.

PROCEDURE

"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.

Trial Locations (15)

130021

The First Hospital of Jilin University, Changchun

200092

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

250000

Shandong jiaotong Hospital, Jinan

300100

Tianjin Nankai Hospital, Tianjin

310003

The First Affiliated Hospital, Zhejiang University, Hangzhou

400038

Third Military Medical University, Chongqing

410011

Second Xiangya Hospital, Central South University, Changsha

430022

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

510260

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

710061

The first affiliated hospital of Xi 'an jiaotong university, Xi'an

730000

The first hospital of Lanzhou university, Lanzhou

750004

General Hospital of Ningxia Medical University, Yinchuan

830054

The First Teaching Hospital of Xinjiang Medical University, Ürümqi

050000

The Second Hospital of Hebei Medical University, Shijiazhuang

030008

Taiyuan Iron and Steel Corporation Hospital, Taiyuan

All Listed Sponsors
lead

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

NCT02510495 - Effect of Endoscopic Papillary Balloon Dilation on ERCP Complications | Biotech Hunter | Biotech Hunter