Jaundice, ObstructiveERCPNCT02477228
Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation
A study testing conventional ERCP and Precut ERCP in people with Jaundice, Obstructive, run by Mansoura University at 1 site in Egypt.
Trial summary
Endoscopic sphincterotomy is now an established method for removal of common bile duct calculi and treatment of papillary stenosis, the sump syndrome and certain cases of ampullary carcinoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Jaundice, Obstructive
- What is being tested?
- conventional ERCP and Precut ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2014to Dec 2014
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients (no limit of age) required ERCP calculator and malignant obstructive jaundice
Who cannot join
- unfit patients history of gastrectomy bleeding tendency larg tumour infiltrating the duodenum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation. A Prospective Randomized Study
Endoscopic sphincterotomy is now an established method for removal of common bile duct calculi and treatment of papillary stenosis, the sump syndrome and certain cases of ampullary carcinoma. It is also generally performed prior to biliary stent placement .Anatomical variations, papillary stenosis, impacted stones, ampullary tumors, duodenal diverticula, and post-gastrojejunostomy states are some of the reasons behind difficult common bile duct (CBD) cannulations . In these situations, the success of CBD cannulation can be enhanced slightly by using the various accessories designed for this purpose.The aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication
Read the detailed description
The aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication This a prospective randomized controlled trial comparing two groups of patients who undergo endoscopic retrograde cholangiopancreatography for obstructive jaundice in Gastrointestinal Surgical center, Mansoura University, Egypt. From January 2014 to December 2014.
Group A consists of 50 patients who will undergo conventional approach and group B consists of 50 patients who undergo needle knife fistulotomy for cannulation of the ampulla of Vater. Randomization was done by paramedical personnel in the ERCP unit by taking a number from an envelope.
Data will be registered in a specially prepared sheet for the purpose of the study. Registered data will include: duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation.
Data also included postoperative hospital stay, serum amylase level and postoperative complications as pancreatitis, perforation, bleeding and cholecystitis. Pancreatitis will be also graded according to its severity depending on the duration of hospital stay.
- Conditions
- Jaundice, Obstructive
- Being tested
- conventional ERCP, Precut ERCP
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional ERCPProcedure or surgery
Also called G1
ERCP was done through the papilla. duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation.
Precut ERCPProcedure or surgery
Also called G 2
ERCP was done through precut from the start duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation.
| Study group | Role | What they receive |
|---|---|---|
| conventional ERCP | Active comparator | ERCP was done through the papilla. duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation. Receives: Procedure: conventional ERCP |
| Precut ERCP | Active comparator | ERCP was done through precut from the start duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation. Receives: Procedure: Precut ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful biliary cannulations
Successful cannulations of biliary system if the guide wire enter the common bile duct
Measured: 1 Day
Secondary outcomes (2)
postprocedure pancreatitis
elevated serum amylase with abdominal pain
Measured: 30 day
postprocedure perforation
duodenal perforation
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Jaundice, ObstructiveStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman El Nakeeb, Mansoura University
- Investigators
- ayman el nakeeb, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477228
- Sponsor's protocol ID
- Biliary cannulation
- Acronym
- ERCP
- Status last verified
- Jun 2015
- First submitted
- 13 Jun 2015
- Last updated
- 22 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
PubMed 2070995Cortas GA, Mehta SN, Abraham NS, Barkun AN. Selective cannulation of the common bile duct: a prospective randomized trial comparing standard catheters with sphincterotomes. Gastrointest Endosc. 1999 Dec;50(6):775-9. doi: 10.1016/s0016-5107(99)70157-4.
PubMed 10570335Swan MP, Alexander S, Moss A, Williams SJ, Ruppin D, Hope R, Bourke MJ. Needle knife sphincterotomy does not increase the risk of pancreatitis in patients with difficult biliary cannulation. Clin Gastroenterol Hepatol. 2013 Apr;11(4):430-436.e1. doi: 10.1016/j.cgh.2012.12.017. Epub 2013 Jan 11.
PubMed 23313840Carr-Locke DL. Biliary access during endoscopic retrograde cholangiopancreatography. Can J Gastroenterol. 2004 Apr;18(4):251-4. doi: 10.1155/2004/364056.
PubMed 15054501
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biliary Cannulation During Endoscopic Retrograde Cholangiopancreatography: Precut Versus Conventional Cannulation. A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02477228
- Acronym / sponsor ID
- ERCP / Biliary cannulation
- Conditions
- Jaundice, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Jun 2015 (estimated)
- 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.
Endoscopic sphincterotomy is now an established method for removal of common bile duct calculi and treatment of papillary stenosis, the sump syndrome and certain cases of ampullary carcinoma. It is also generally performed prior to biliary stent placement .Anatomical variations, papillary stenosis, impacted stones, ampullary tumors, duodenal diverticula, and post-gastrojejunostomy states are some of the reasons behind difficult common bile duct (CBD) cannulations . In these situations, the success of CBD cannulation can be enhanced slightly by using the various accessories designed for this purpose.The aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication
Detailed description
The aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of Vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication This a prospective randomized controlled trial comparing two groups of patients who undergo endoscopic retrograde cholangiopancreatography for obstructive jaundice in Gastrointestinal Surgical center, Mansoura University, Egypt. From January 2014 to December 2014.
Group A consists of 50 patients who will undergo conventional approach and group B consists of 50 patients who undergo needle knife fistulotomy for cannulation of the ampulla of Vater. Randomization was done by paramedical personnel in the ERCP unit by taking a number from an envelope.
Data will be registered in a specially prepared sheet for the purpose of the study. Registered data will include: duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation.
Data also included postoperative hospital stay, serum amylase level and postoperative complications as pancreatitis, perforation, bleeding and cholecystitis. Pancreatitis will be also graded according to its severity depending on the duration of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional ERCP | Active comparator | Procedure: conventional ERCPERCP was done through the papilla. duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation. |
| Precut ERCP | Active comparator | Procedure: Precut ERCPERCP was done through precut from the start duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients (no limit of age) required ERCP calculator and malignant obstructive jaundice
Key exclusion criteria (1 listed)
- unfit patients history of gastrectomy bleeding tendency larg tumour infiltrating the duodenum
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 |
|---|---|---|
| conventional ERCPAlso: G1ERCP was done through the papilla. duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation. | Procedure or surgery | conventional ERCP |
| Precut ERCPAlso: G 2ERCP was done through precut from the start duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation. | Procedure or surgery | Precut ERCP |
Primary outcome
Successful biliary cannulations
Time frame: 1 Day
Successful cannulations of biliary system if the guide wire enter the common bile duct
2 secondary outcomes
postprocedure pancreatitis
Time frame: 30 day
postprocedure perforation
Time frame: 30 day
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 Jun 2015.
- Results publication: PubMed 2070995Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
- Results publication: PubMed 10570335Cortas GA, Mehta SN, Abraham NS, Barkun AN. Selective cannulation of the common bile duct: a prospective randomized trial comparing standard catheters with sphincterotomes. Gastrointest Endosc. 1999 Dec;50(6):775-9. doi: 10.1016/s0016-5107(99)70157-4.
- Results publication: PubMed 23313840Swan MP, Alexander S, Moss A, Williams SJ, Ruppin D, Hope R, Bourke MJ. Needle knife sphincterotomy does not increase the risk of pancreatitis in patients with difficult biliary cannulation. Clin Gastroenterol Hepatol. 2013 Apr;11(4):430-436.e1. doi: 10.1016/j.cgh.2012.12.017. Epub 2013 Jan 11.
- Results publication: PubMed 15054501Carr-Locke DL. Biliary access during endoscopic retrograde cholangiopancreatography. Can J Gastroenterol. 2004 Apr;18(4):251-4. doi: 10.1155/2004/364056.
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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.
ayman el nakeeb, MD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional ERCP and Precut ERCP in people with Jaundice, Obstructive, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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 Jun 2015. 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 Egypt. 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?
Successful biliary cannulations (time frame: 1 Day). 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 NCT02477228, which also lists 4 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 22 Jun 2015.