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Endoscopic Retrograde CholangiopancreatographyNCT06512246

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

An observational study of Endoscopic Retrograde Cholangiopancreatography, run by Beijing Friendship Hospital at 1 site in China.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
195 participants
Where
1 siteChina
Study dates
1 Apr 2024to 1 Jul 2024
Phase
Observational
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

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Beijing Friendship Hospital

    Beijing, Beijing Municipality, 100050

Other trials in China

About this study

Official title: 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.

Read the 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.

Keywords
Endoscopic Retrograde Cholangiopancreatography, Gastrointestinal Reconstruction, Remedial Measure

What is being measured

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

  1. Rate of Reaching Duodenal Papilla

    successfully reaching duodenal papilla during the endoscopic procedure

    Measured: during the operation

Secondary outcomes (4)
  1. Successful Intubation Rate

    successful intubation during the ERCP procedure

    Measured: during the operation

  2. Successful Endoscopic Treatment Rate

    successful endoscopic treatment during the ERCP procedure

    Measured: during the operation

  3. Effective Rate of Remedial Measures

    remedial measures successfully relief symptom

    Measured: during the operation

  4. 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.

    Measured: during the operation

Timeline

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

  1. First posted22 Jul 2024
  2. Study start1 Apr 2024
  3. Primary completion1 Jun 2024
  4. Study completion1 Jul 2024

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06512246
Sponsor's protocol ID
BFHHZS20240136
Status last verified
Jul 2024
First submitted
16 Jul 2024
Last updated
22 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Endoscopic Retrograde Cholangiopancreatography, run by Beijing Friendship Hospital at 1 site 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 3 inclusion and 2 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 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Rate of Reaching Duodenal Papilla (time frame: during the operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 22 Jul 2024.

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