Failure Factors of ERCP After Gastrointestinal Reconstruction and Effectiveness Analysis of Remedial Measures

Failure Factors of Endoscopic Retrograde Cholangiopancreatography After Gastrointestinal Reconstruction and Effectiveness of Remedial Measures

This is a retrospective study, including 195 patients with gastrointestinal reconstruction, who treated with Endoscopic Retrograde Cholangiopancreatography (ERCP) at Beijing friendship hospital. The investigators assessed the outcomes of failure factors of ERCP and effectiveness of remedial measures.

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography

Detailed Description

Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive procedure in which an endoscope is inserted into the descending part of the duodenum through the duodenal papilla, and special instruments are used to enter the bile duct or pancreatic duct for examination and treatment with the assistance of X-ray.

For normal upper digestive tract anatomy, the technical success rate of ERCP was 97.6% and the treatment success rate was 95.2%. But when the upper GI tract anatomy is altered due to surgery, standard ERCP is operationally challenging and sometimes impossible. For the treatment of gastroduodenal malignant tumors, obesity and peptic ulcer, subtotal gastrectomy and total gastrectomy are often used in combination with gastrointestinal reconstruction. The most common gastrointestinal reconstruction procedures include Billroth I, Billroth II, Roux-en-Y and so on. Billroth I is a gastroduodenal anastomosis, which is more consistent with the original physiological condition of the gastrointestinal tract, and usually does not increase the difficulty of ERCP operation. Billroth II closed the duodenal end and anastomosed the stomach and jejunum to form an input loop and an output loop behind the gastrointestinal anastomosis. Roux-en-Y is to close the duodenal end and transect the jejunum with Treitz ligament at a distance of 10-15cm. The distal end is anastomosed with the remnant stomach, and the proximal end is anastomosed with the jejunum at a distance of 45-60cm from the gastrointestinal anastomosis. Due to the change of gastrointestinal structure after gastrointestinal reconstruction, patients may be complicated with cholelithiasis, pancreaticobile duct stenosis and other diseases, requiring ERCP to assist in diagnosis and treatment. However, the alteration of digestive tract anatomical structure and possible postoperative complications, including anastomotic fistula and anastomotic stenosis, may lead to certain difficulty in ERCP operation. The success of ERCP includes the success of ERCP implantation, ERCP intubation and ERCP treatment. According to previous studies at home and abroad, the relevant success rates of ERCP after gastrointestinal reconstruction are 82.3%-90.5%, 77.5%-88.6% and 46.3%-88.6%, respectively. Current studies suggest that the gastrointestinal remodeling procedure, the type of operating endoscope, and the experience of operating physicians are related to the success rate of ERCP operation. When ERCP fails, it can be treated with ERCP again, percutaneous hepatic puncture biliary drainage (PTCD), endoscopic ultrasound, and surgery.

In a retrospective analysis, 195 patients with gastrointestinal reconstruction, who treated with Endoscopic Retrograde Cholangiopancreatography (ERCP) at Beijing Friendship Hospital were studied. The investigators assessed the outcomes of failure factors of ERCP and effectiveness of remedial measures.

• Study Type: Observational
• Enrollment (Actual): 195

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who diagnosed with gastrointestinal reconstruction underwent ERCP at Beijing Friendship Hospital.

Description

Inclusion Criteria:

• Age ≥18 years old.
• After gastrointestinal reconstruction (Billroth Ⅱ Anastomosis, Roux-en-Y Anastomosis).
• Endoscopic retrograde cholangiopancreatography (ERCP) was performed for common bile duct stone with choledocholithiasis, pancreatic duct stenosis, or obstructive jaundice with endoscopic indication.

Exclusion Criteria:

• After Billroth I Anastomosis.
• Accompanied by serious cardiopulmonary disease or coagulation dysfunction.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Reaching Duodenal Papilla	successfully reaching duodenal papilla during the endoscopic procedure	during the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Intubation Rate	successful intubation during the ERCP procedure	during the operation
Successful Endoscopic Treatment Rate	successful endoscopic treatment during the ERCP procedure	during the operation
Effective Rate of Remedial Measures	remedial measures successfully relief symptom	during the operation
ERCP-related complication rate	The complications include pancreatitis, hemorrhage, perforation, pneumonia, etc. The results of intraoperative endoscopic observation, postoperative symptoms and signs, blood routine examination, amylase, lipase, and imaging and endoscopic examination were measured.	during the operation

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Fujing Lv, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopic Retrograde Cholangiopancreatography; Gastrointestinal Reconstruction; Remedial Measure
• Other Study ID Numbers: BFHHZS20240136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No