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.
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
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography
- 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.
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.
Rate of Reaching Duodenal Papilla
successfully reaching duodenal papilla during the endoscopic procedure
Measured: during the operation
Secondary outcomes (4)
Successful Intubation Rate
successful intubation during the ERCP procedure
Measured: during the operation
Successful Endoscopic Treatment Rate
successful endoscopic treatment during the ERCP procedure
Measured: during the operation
Effective Rate of Remedial Measures
remedial measures successfully relief symptom
Measured: 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.
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.
- First posted22 Jul 2024
- Study start1 Apr 2024
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Retrograde CholangiopancreatographyStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fujing Lv, Principal investigator, Beijing Friendship Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Failure Factors of Endoscopic Retrograde Cholangiopancreatography After Gastrointestinal Reconstruction and Effectiveness of Remedial Measures
- ClinicalTrials.gov ID
- NCT06512246
- Acronym / sponsor ID
- BFHHZS20240136
- Keywords
- Endoscopic Retrograde Cholangiopancreatography, Gastrointestinal Reconstruction, Remedial Measure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who diagnosed with gastrointestinal reconstruction underwent ERCP at Beijing Friendship Hospital.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- After Billroth I Anastomosis.
- Accompanied by serious cardiopulmonary disease or coagulation dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Reaching Duodenal Papilla
Time frame: during the operation
successfully reaching duodenal papilla during the endoscopic procedure
4 secondary outcomes
Successful Intubation Rate
Time frame: during the operation
Successful Endoscopic Treatment Rate
Time frame: during the operation
Effective Rate of Remedial Measures
Time frame: during the operation
ERCP-related complication rate
Time frame: during the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fujing Lv principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
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.