A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP

NCT03416205 | Unknown

• 1 other identifier: 2017-XHNK-001
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed to remove bile duct stones.Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) are 3 methods used to enlarge the papillary orifice, but their efficacy and safety remains controversial. This study aimed to compare these methods for treating common bile duct (CBD) stones.

Conditions

ERCP

Outcome Measures

Primary Outcomes (1)

• the incidence of composite events of infection, hemorrhage, perforation, pancreatitis

  Investigators comprehensively assess whether the hemorrhage, perforation, pancreatitis and other complications of retrograde cholangiopancreatography (ERCP) happen or not by clinical sympton and blood index 1 day after the ERCP. The blood index includes CRP, amylase,lipase,leukocyte,red blood cell,hemoglobin.Besides,CT will be done if necessary.Finally investigators use statistical method to analyse the incidence of composite events of infection, hemorrhage, perforation, pancreatitis.

  3 and 24 hours after the ERCP

Secondary Outcomes (1)

• Recurrence rate of bile duct stones

  1 year after the ERCP.

Study Arms (3)

EST

EXPERIMENTAL

EST is an operation using the Erbao electric knife and Three-cavity incision knife to make a large incision to the duodenal nipples，and the incision scope is the nipple mouth uplift length of 4/5. It has been used since 1974. The technique is intuitive and intact. However, EST cut too small to achieve the purpose of treatment and will affect the next step, and if the incision is too large it may be easier to occur gastrointestinal perforation and bleeding.The EST will also damage the anatomy of the Oddi sphincter structure,which causes bacterial reflux to the bile duct, the recurrence of CBD.Some surgeons prefer it because it's postoperative pancreatitis rate is lower and it may be easier to find the lesion position if bleeding or perforation occurs.

Device: Erbao electric knife; Device: Three-cavity incision knife

EPBD

EXPERIMENTAL

EPBD is an operation using the Columnar expansion balloon to expand duodenal to achieve the purpose of using the basket and other instruments to take stone out. Balloon expansion may retain part of the sphincter not destroyed, and basically retain the normal physiological function of the nipple sphincter.Thus it may reduce the risk of recurrence of stones and bacterial reflux. However,the postoperative pancreatitis rate is high(4.8% -19.5% ), and nipple sphincter tear is uncontrollable in EPBD.If the digestive tract perforation or bleeding occur after EPBD,it is hard to accurately find the lesion position.Some surgeons prefer it for it's lower bleeding and perforation rate.

Device: Columnar expansion balloon

sEST+EPBD

EXPERIMENTAL

sEST+EPBD is an operation combining EST and EPBD. Investigators use the Erbao electric knife and Three-cavity incision knife to make a small incision to the duodenal nipples, and the incision length is less than 5mm while the incision scope is less than the nipple mouth uplift length of 1/2. Then, Investigators match the appropriate Columnar expansion balloon according to the diameter of the common bile duct and gradually expand the duodenal nipples.This method allows the nipple sphincter to be cut in a small range, then the balloon can guide the direction of the nipple sphincter tearing after the expansion , so that the digestive tract bleeding, perforation may be smaller and more controllable. Besides,it may reduce postoperative pancreatitis rate and the recurrence rate of stones.

Device: Erbao electric knife; Device: Three-cavity incision knife; Device: Columnar expansion balloon

Interventions

Erbao electric knife DEVICE

Erbao electric knife is used to cut the Duodenal sphincter

EST; sEST+EPBD

Three-cavity incision knife DEVICE

Three-cavity incision knife is used to cut the Duodenal sphincter

EST; sEST+EPBD

Columnar expansion balloon DEVICE

Columnar expansion balloon is used to expand the the Duodenal sphincter

EPBD; sEST+EPBD

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-80 years old
• CT or MRCP diagnose the patients with Common bile duct stones
• The diameter of the stone is less than or equal to 1.5cm
• Patients with the indications for ERCP
• Patients and their families agree to participate in the trial

You may not qualify if:

• Stones are too large (\> 1.5cm)
• A history of gastrointestinal surgery
• ERCP and EST or EPBD surgery history
• Patients generally poor, total bilirubin\> 200umol / L or PT time extension\> 3s
• Patients with mental illness or other serious heart and lung disease

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, 510282, China

Location

Study Officials

• Changhui Yu, Doctor

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: January 31, 2018
• Study Start: July 20, 2017
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 19, 2018

Record last verified: 2017-05

Locations

CN (1)