Intubation;DifficultNCT03556072
If Different Types of Periampullary Diverticula Affect ERCP Cannulation?
An observational study of Intubation;Difficult, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
To study the influence of different types of periampullary diverticulum(PAD) on ERCP difficult cannulation and postoperative complications. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- Routine ERCP
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 1 Oct 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-90 years old patients with ERCP indications
Who may be able to join
- 18-90 years old ERCP patients
- With native papilla
Who cannot join
- Unwillingness or inability to consent for the study
- Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 / L) or using anti-coagulation drugs
- Previous ERCP
- Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock
- Biliary-duodenal fistula confirmed during ERCP
- Pregnant women or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
About this study
To study the influence of different types of periampullary diverticulum(PAD) on ERCP difficult cannulation and postoperative complications.
Read the detailed description
Periampullary diverticula (PAD) are extraluminal out-pouching of the duodenum mucosa often occurring within a radius of 2-3 cm from the ampulla of Vater or hepatopancreatic ampulla. More PAD cases have been identified over recent years, and it's generally believed that up to 27% of elderly cases may have PAD. Several classifications of PAD have been proposed, and the most commonly used distinguishes intraluminal and extraluminal diverticula. Recent studies suggest that PAD is a risk factor for the development of bile duct diseases, and it may cause endoscopic retrograde cholangiopancreatography (ERCP) procedures to fail, but some other studies have come to the opposite conclusion.
During ERCP procedures, the investigators found that different types of PAD seem to have some differences in the size of the diverticulum, difficulty in intubation, and complications. The investigators plan to this retrospectively study collecting 4 years of cases to evaluate the clinical features of different types of PAD in terms of difficult cannulation and complications.
- Conditions
- Intubation;Difficult
- Being tested
- Routine ERCP
- Keywords
- ERCP, periampullary diverticula, difficulty cannulation, complication, biliary disorder
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine ERCPOther
| Study group | Role | What they receive |
|---|---|---|
| Intradiverticular papilla (IDP) group | Routine ERCP, recording the endoscopic procedures and observing the intra- and post-operative parameters Receives: Other: Routine ERCP | |
| Juxtapapillary diverticulum (JPD) group | Routine ERCP, recording the endoscopic procedures and observing the intra- and post-operative parameters Receives: Other: Routine ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulty cannulation
The inability to achieve selective biliary cannulation by the standard ERCP technique within 10 minutes or 5 attempts or failure of access to the major papilla.
Measured: 1 month
Secondary outcomes (10)
Diameter of diverticulum
Maximum diameter of PAD observed during ERCP
Measured: 1 month
Diameter of common bile duct
Maximum diameter of common bile duct observed during ERCP
Measured: 1 month
X-ray exposure time
The total radiography time during ERCP
Measured: 1 month
Pancreatic duct insertion times
Times of any accessories goes into the pancreatic duct, no matter how depth
Measured: 1 month
Post-ERCP pancreatitis
Upper abdominal pain with serum amylase elevation more than 3 times after the procedure
Measured: 1 month
Perforation
CT scan shows retroperitoneal space fluid or gas
Measured: 1 month
Acute cholangitis
Intermittent chills and fever after ERCP
Measured: 1 month
Operation time
From successful biliary intubation to end of operation
Measured: 1 month
Secondary treatment rate
Some patients require secondary treatment, including management of primary diseases and complications
Measured: 1 month
Hospital stay
Length of stay in hospital
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Jan 2014
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- 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
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xun Li, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Xun Li, M.D., Principal investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556072
- Sponsor's protocol ID
- PAD affects ERCP cannulation
- Status last verified
- Oct 2018
- First submitted
- 2 Jun 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lobo DN, Balfour TW, Iftikhar SY. Periampullary diverticula: consequences of failed ERCP. Ann R Coll Surg Engl. 1998 Sep;80(5):326-31.
PubMed 9849331Cappell MS, Mogrovejo E, Manickam P, Batke M. Endoclips to facilitate cannulation and sphincterotomy during ERCP in a patient with an ampulla within a large duodenal diverticulum: case report and literature review. Dig Dis Sci. 2015 Jan;60(1):168-73. doi: 10.1007/s10620-014-3321-1. Epub 2014 Aug 20. No abstract available.
PubMed 25138902Kim KY, Han J, Kim HG, Kim BS, Jung JT, Kwon JG, Kim EY, Lee CH. Late Complications and Stone Recurrence Rates after Bile Duct Stone Removal by Endoscopic Sphincterotomy and Large Balloon Dilation are Similar to Those after Endoscopic Sphincterotomy Alone. Clin Endosc. 2013 Nov;46(6):637-42. doi: 10.5946/ce.2013.46.6.637. Epub 2013 Nov 19.
PubMed 24340257Katsinelos P, Chatzimavroudis G, Tziomalos K, Zavos C, Beltsis A, Lazaraki G, Terzoudis S, Kountouras J. Impact of periampullary diverticula on the outcome and fluoroscopy time in endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int. 2013 Aug;12(4):408-14. doi: 10.1016/s1499-3872(13)60063-6.
PubMed 23924499Tyagi P, Sharma P, Sharma BC, Puri AS. Periampullary diverticula and technical success of endoscopic retrograde cholangiopancreatography. Surg Endosc. 2009 Jun;23(6):1342-5. doi: 10.1007/s00464-008-0167-7. Epub 2008 Sep 26.
PubMed 18818967
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- If Different Types of Periampullary Diverticula Affect ERCP Cannulation?
- ClinicalTrials.gov ID
- NCT03556072
- Acronym / sponsor ID
- PAD affects ERCP cannulation
- Conditions
- Intubation;Difficult
- Keywords
- ERCP, periampullary diverticula, difficulty cannulation, complication, biliary disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 14 Jun 2018 (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.
To study the influence of different types of periampullary diverticulum(PAD) on ERCP difficult cannulation and postoperative complications.
Detailed description
Periampullary diverticula (PAD) are extraluminal out-pouching of the duodenum mucosa often occurring within a radius of 2-3 cm from the ampulla of Vater or hepatopancreatic ampulla. More PAD cases have been identified over recent years, and it's generally believed that up to 27% of elderly cases may have PAD. Several classifications of PAD have been proposed, and the most commonly used distinguishes intraluminal and extraluminal diverticula. Recent studies suggest that PAD is a risk factor for the development of bile duct diseases, and it may cause endoscopic retrograde cholangiopancreatography (ERCP) procedures to fail, but some other studies have come to the opposite conclusion.
During ERCP procedures, the investigators found that different types of PAD seem to have some differences in the size of the diverticulum, difficulty in intubation, and complications. The investigators plan to this retrospectively study collecting 4 years of cases to evaluate the clinical features of different types of PAD in terms of difficult cannulation and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradiverticular papilla (IDP) group | – | Other: Routine ERCPRoutine ERCP, recording the endoscopic procedures and observing the intra- and post-operative parameters |
| Juxtapapillary diverticulum (JPD) group | – | Other: Routine ERCPRoutine ERCP, recording the endoscopic procedures and observing the intra- and post-operative parameters |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-90 years old patients with ERCP indications
Key inclusion criteria (2 listed)
- 18-90 years old ERCP patients
- With native papilla
Key exclusion criteria (7 listed)
- Unwillingness or inability to consent for the study
- Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 / L) or using anti-coagulation drugs
- Previous ERCP
- Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy
- Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine ERCP | Other | Intradiverticular papilla (IDP) group, Juxtapapillary diverticulum (JPD) group |
Primary outcome
Difficulty cannulation
Time frame: 1 month
The inability to achieve selective biliary cannulation by the standard ERCP technique within 10 minutes or 5 attempts or failure of access to the major papilla.
10 secondary outcomes
Diameter of diverticulum
Time frame: 1 month
Diameter of common bile duct
Time frame: 1 month
X-ray exposure time
Time frame: 1 month
Pancreatic duct insertion times
Time frame: 1 month
Post-ERCP pancreatitis
Time frame: 1 month
Perforation
Time frame: 1 month
Acute cholangitis
Time frame: 1 month
Operation time
Time frame: 1 month
Secondary treatment rate
Time frame: 1 month
Hospital stay
Time frame: 1 month
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 9 Oct 2018.
- Results publication: PubMed 9849331Lobo DN, Balfour TW, Iftikhar SY. Periampullary diverticula: consequences of failed ERCP. Ann R Coll Surg Engl. 1998 Sep;80(5):326-31.
- Results publication: PubMed 25138902Cappell MS, Mogrovejo E, Manickam P, Batke M. Endoclips to facilitate cannulation and sphincterotomy during ERCP in a patient with an ampulla within a large duodenal diverticulum: case report and literature review. Dig Dis Sci. 2015 Jan;60(1):168-73. doi: 10.1007/s10620-014-3321-1. Epub 2014 Aug 20. No abstract available.
- Results publication: PubMed 24340257Kim KY, Han J, Kim HG, Kim BS, Jung JT, Kwon JG, Kim EY, Lee CH. Late Complications and Stone Recurrence Rates after Bile Duct Stone Removal by Endoscopic Sphincterotomy and Large Balloon Dilation are Similar to Those after Endoscopic Sphincterotomy Alone. Clin Endosc. 2013 Nov;46(6):637-42. doi: 10.5946/ce.2013.46.6.637. Epub 2013 Nov 19.
- Results publication: PubMed 23924499Katsinelos P, Chatzimavroudis G, Tziomalos K, Zavos C, Beltsis A, Lazaraki G, Terzoudis S, Kountouras J. Impact of periampullary diverticula on the outcome and fluoroscopy time in endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int. 2013 Aug;12(4):408-14. doi: 10.1016/s1499-3872(13)60063-6.
- Results publication: PubMed 18818967Tyagi P, Sharma P, Sharma BC, Puri AS. Periampullary diverticula and technical success of endoscopic retrograde cholangiopancreatography. Surg Endosc. 2009 Jun;23(6):1342-5. doi: 10.1007/s00464-008-0167-7. Epub 2008 Sep 26.
- Individual participant dataSharing planned: No
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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.
Xun Li, M.D. principal investigator
Hepatopancreatobiliary Surgery Institute of Gansu Province
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 Intubation;Difficult, run by Hepatopancreatobiliary Surgery Institute of Gansu Province 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 2 inclusion and 7 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 9 Oct 2018. 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?
Difficulty cannulation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03556072, which also lists 5 linked publications.
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 9 Oct 2018.