CholedocholithiasisNCT00173368
Study of Endoscopic Sphincterotomy With Needle Knife Papillotome in Patients of Ampullary Impacted Stone
An observational study of Choledocholithiasis and Endoscopy, run by National Taiwan University Hospital.
Trial summary
Using a needle knife papillotome by an experienced endoscopist, endoscopic sphincterotomies were performed in difficult cannulation cases. In a prospectively collected database, we investigate the complications of those with ampullary impacted stone. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Choledocholithiasis, Endoscopy
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Mar 2005
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- choledocholithiasis patients and an ampullary impacted stone
Who cannot join
- patients with liver cirrhosis , pregnancy, history of abdominal malignancy, bleeding diathesis, ileus, renal failure
About this study
Using a needle knife papillotome by an experienced endoscopist, endoscopic sphincterotomies were performed in difficult cannulation cases. In a prospectively collected database, we investigate the complications of those with ampullary impacted stone.
Read the detailed description
The endoscopic sphincterotomy with needle knife papillotome is a well-established advanced endoscopic technique in difficult cannulation cases. Choledocholithiasis impacted at the ampulla of Vater is occasionally seen. Inflammed surrounding mucosa frequently accompanies. Whether sphincterotomy with a needle knife increases the bleeding complications is to be elucidated in this study.
- Conditions
- Choledocholithiasis, Endoscopy
- Keywords
- Sphincterotomy, needle knife, hemorrhage, complication
- Medical subject headings
- Choledocholithiasis, Hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Defined population
- Time perspective
- Other
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hsiu-Po Wang, MD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173368
- Sponsor's protocol ID
- 9461700651
- Status last verified
- Aug 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Endoscopic Sphincterotomy With Needle Knife Papillotome in Patients of Ampullary Impacted Stone
- ClinicalTrials.gov ID
- NCT00173368
- Acronym / sponsor ID
- 9461700651
- Conditions
- Choledocholithiasis, Endoscopy
- Keywords
- Sphincterotomy, needle knife, hemorrhage, complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Mar 2005
- First posted
- 15 Sep 2005 (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.
Using a needle knife papillotome by an experienced endoscopist, endoscopic sphincterotomies were performed in difficult cannulation cases. In a prospectively collected database, we investigate the complications of those with ampullary impacted stone.
Detailed description
The endoscopic sphincterotomy with needle knife papillotome is a well-established advanced endoscopic technique in difficult cannulation cases. Choledocholithiasis impacted at the ampulla of Vater is occasionally seen. Inflammed surrounding mucosa frequently accompanies. Whether sphincterotomy with a needle knife increases the bleeding complications is to be elucidated in this study.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- choledocholithiasis patients and an ampullary impacted stone
Key exclusion criteria (1 listed)
- patients with liver cirrhosis , pregnancy, history of abdominal malignancy, bleeding diathesis, ileus, renal failure
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
Not reported in the source record.
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 15 Sep 2005.
Related trials for Choledocholithiasis
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Recruiting
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Cholecystectomy, Laparoscopic, Choledocholithiasis
Recruiting
Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
Choledocholithiasis, Common Bile Duct Stones
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
RecruitingObservational study
Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis
Cholelithiasis Associated With Common Bile Duct Stones
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.
Hsiu-Po Wang, MD study chair
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Choledocholithiasis and Endoscopy, run by National Taiwan University Hospital.
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 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
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 15 Sep 2005.