Clinical trial NCT06512246: Failure Factors of ERCP After Gastrointestinal Reconstruction and Effectiveness Analysis of Remedial Measures
Official title: Failure Factors of Endoscopic Retrograde Cholangiopancreatography After Gastrointestinal Reconstruction and Effectiveness of Remedial Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Retrograde Cholangiopancreatography
Keywords: Endoscopic Retrograde Cholangiopancreatography
Gastrointestinal Reconstruction
Remedial Measure
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who diagnosed with gastrointestinal reconstruction underwent ERCP at Beijing Friendship Hospital.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Reaching Duodenal Papilla
timeFrame: during the operation
Secondary outcomes:
measure: Successful Intubation Rate
timeFrame: during the operation
measure: Successful Endoscopic Treatment Rate
timeFrame: during the operation
measure: Effective Rate of Remedial Measures
timeFrame: during the operation
measure: ERCP-related complication rate
timeFrame: during the operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Fujing Lv
role: PRINCIPAL_INVESTIGATOR
References: