Pancreaticobiilary DiseasesNCT03550768
Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography
An observational study of Pancreaticobiilary Diseases and Endoscopic Retrograde Cholangiopancreatography, run by Air Force Military Medical University, China at 4 sites in China.
Trial summary
Selective cannulation is an essential step for the success of ERCP. The successful cannulation is influenced by types of disease (such as Sphincter of Oddi Dysfunction and duodenal stricture), the experience of endoscopists and the anatomy of papilla. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreaticobiilary Diseases, Endoscopic Retrograde Cholangiopancreatography
- What is being tested?
- MDP
- How many people
- 658 participants
- Where
- 4 sitesChina
- Study dates
- 7 May 2018to 30 Apr 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with native papilla who underwent ERCP
Who may be able to join
- age 18-80
- Patients with native papilla who underwent ERCP
Who cannot join
- Prior endoscopic sphincterotomy
- Minor pancreatic duct as the targeted duct
- History of prior upper gastrointestinal surgery, such as Billroth I, II and Roux-en-Y
- Fistula of MDP
- Papillary carcinoma or adenoma
- Duodenal obstruction, type II
Show all 9Show fewer
- Prior stent placement in common bile duct or pancreatic duct
- Pregnant or breastfeeding women
- Unwilling or inability to provide consent
Trial locations and contacts
4 sites in 1 country.
China4 sites
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400010
Huaihe Hospital of Henan University
Kaifeng, Henan, 475000
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Department of gastroenterology, Successful Hospital of Xiamen university
Xiamen, Fujian, 361001
About this study
Official title: Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Selective cannulation is an essential step for the success of ERCP. The successful cannulation is influenced by types of disease (such as Sphincter of Oddi Dysfunction and duodenal stricture), the experience of endoscopists and the anatomy of papilla. It is suggested that the size, morphology, orientation and location of major duodenal papilla (MDP), could cause a difficult cannulation (Endoscopy 2016; 48: 657-683). However, the related evidences are limited. The investigators hypothesized that special anatomy of papilla, such as a lanky shape (defined by the higher ratio of length to width) and a deeper location, could increase the difficulty of cannulation. Here the investigators investigated the effects of the anatomy of major duodenal papilla on post-ERCP pancreatitis and the procedure of cannulation in patients undergoing ERCP.
- Being tested
- MDP
- Keywords
- ERCP, anatomy of major duodenal papilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDPOther
evaluate the anatomy of each major duodenal papilla before selective cannulation during ERCP
| Study group | Role | What they receive |
|---|---|---|
| MDP | ERCP was performed by trainees or trainers. Before the cannulation, the photo of major duodenal papilla will be taken carefully to evaluate its size, morphology, orientation and location. All patients initially received wire-guided cannulation with a sphincterotome, If cannulation failed, precut sphincterotomy or the double-wire technique was performed when appropriate. Therapeutic manipulation (eg, sphincterotomy, balloon dilation, stone extraction, and stenting) was done when appropriate. Pancreatic duct stent placement was performed at the discretion of the endoscopists. Receives: Other: MDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-ERCP pancreatitis incidence
frequency of post-ERCP pancreatitis
Measured: 48 hours
Secondary outcomes (5)
Rate of difficult cannulation
difficult cannulation was defined as when total cannulation time was more than 5minutes, total cannulation attempts more than 5 times or inadvertent pancreatic duct cannulation more than 1 time.
Measured: 3 hours
Cannulation attempts
the sphincterotome touching the papilla for at least 5 seconds will be considered as one attempt.
Measured: 3 hours
Total cannulation time
the time from the moment the sphincterotome touch the papilla to the guide wire advance into the target duct.
Measured: 3 hours
Unintended pancreatic duct cannulation
the guide wire unintentionally entered into the undesired pancreatic duct
Measured: 3 hours
Complication rate
frequency of any adverse outcome that required hospital admission or prolonged hospital stay necessary for management of the complication, including pancreatitis, bleeding, biliary infection or perforation.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start7 May 2018
- Primary completion20 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreaticobiilary DiseasesStudies 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
- Prospective
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Huaihe Hospital of Henan University, Successful Hospital of Xiamen university
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550768
- Sponsor's protocol ID
- KY20180081-2
- Status last verified
- Dec 2019
- First submitted
- 16 May 2018
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Zhao J, Wang L, Ning B, Zeng W, Tao Q, Ren G, Liang S, Luo H, Wang B, Farrell JJ, Pan Y, Guo X, Wu K. Relationship between papilla-related variables and post endoscopic retrograde cholangiopancreatography pancreatitis: A multicenter, prospective study. J Gastroenterol Hepatol. 2020 Dec;35(12):2184-2191. doi: 10.1111/jgh.15135. Epub 2020 Jun 29.
PubMed 32511794
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
- ClinicalTrials.gov ID
- NCT03550768
- Acronym / sponsor ID
- KY20180081-2
- Keywords
- ERCP, anatomy of major duodenal papilla
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Huaihe Hospital of Henan University, Successful Hospital of Xiamen university
- Study start
- 7 May 2018 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 8 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.
Selective cannulation is an essential step for the success of ERCP. The successful cannulation is influenced by types of disease (such as Sphincter of Oddi Dysfunction and duodenal stricture), the experience of endoscopists and the anatomy of papilla. It is suggested that the size, morphology, orientation and location of major duodenal papilla (MDP), could cause a difficult cannulation (Endoscopy 2016; 48: 657-683). However, the related evidences are limited. The investigators hypothesized that special anatomy of papilla, such as a lanky shape (defined by the higher ratio of length to width) and a deeper location, could increase the difficulty of cannulation. Here the investigators investigated the effects of the anatomy of major duodenal papilla on post-ERCP pancreatitis and the procedure of cannulation in patients undergoing ERCP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDP | – | Other: MDPERCP was performed by trainees or trainers. Before the cannulation, the photo of major duodenal papilla will be taken carefully to evaluate its size, morphology, orientation and location. All patients initially received wire-guided cannulation with a sphincterotome, If cannulation failed, precut sphincterotomy or the double-wire technique was performed when appropriate. Therapeutic manipulation (eg, sphincterotomy, balloon dilation, stone extraction, and stenting) was done when appropriate. Pancreatic duct stent placement was performed at the discretion of the endoscopists. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with native papilla who underwent ERCP
Key inclusion criteria (2 listed)
- age 18-80
- Patients with native papilla who underwent ERCP
Key exclusion criteria (9 listed)
- Prior endoscopic sphincterotomy
- Minor pancreatic duct as the targeted duct
- History of prior upper gastrointestinal surgery, such as Billroth I, II and Roux-en-Y
- Fistula of MDP
- Papillary carcinoma or adenoma
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 |
|---|---|---|
| MDPevaluate the anatomy of each major duodenal papilla before selective cannulation during ERCP | Other | MDP |
Primary outcome
post-ERCP pancreatitis incidence
Time frame: 48 hours
frequency of post-ERCP pancreatitis
5 secondary outcomes
Rate of difficult cannulation
Time frame: 3 hours
Cannulation attempts
Time frame: 3 hours
Total cannulation time
Time frame: 3 hours
Unintended pancreatic duct cannulation
Time frame: 3 hours
Complication rate
Time frame: 48 hours
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 26 Dec 2019.
- Derived from this study: PubMed 32511794Wang X, Zhao J, Wang L, Ning B, Zeng W, Tao Q, Ren G, Liang S, Luo H, Wang B, Farrell JJ, Pan Y, Guo X, Wu K. Relationship between papilla-related variables and post endoscopic retrograde cholangiopancreatography pancreatitis: A multicenter, prospective study. J Gastroenterol Hepatol. 2020 Dec;35(12):2184-2191. doi: 10.1111/jgh.15135. Epub 2020 Jun 29.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreaticobiilary Diseases and Endoscopic Retrograde Cholangiopancreatography, run by Air Force Military Medical University, China at 4 sites 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 9 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 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
post-ERCP pancreatitis incidence (time frame: 48 hours). 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 NCT03550768, which also lists 1 linked publication.
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 26 Dec 2019.