Cholecystitis, AcuteNCT02394327
Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy
A study testing 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA) and 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA) in people with Cholecystitis, Acute and Common Bile Duct Calculi, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis, but temporary decompression of the gallbladder (GB) through percutaneous or endoscopic route can be required to alleviate inflammatory process and reach an appropriate time for elective surgery in patients with high operative… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cholecystitis, Acute, Common Bile Duct Calculi
- What is being tested?
- 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA) and 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- grade II or III acute cholecystitis met Tokyo 13 diagnostic criteria
- a high suspicion of CBD stone based on laboratory and imaging study
- informed consent given.
Who cannot join
- bilo-pancreatic malignancy or surgically altered enteric anatomy
- subsequent elective surgery is expected to be impossible even after GB decompression based on American Society of Anesthesiologist class
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Naso-gallbladder Drainage Versus Gallbladder Stenting Before Elective Cholecystectomy in Patients With Acute Cholecystitis and a High Suspicion of Common Bile Duct Stone; A Prospective Randomized Preliminary Study
Early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis, but temporary decompression of the gallbladder (GB) through percutaneous or endoscopic route can be required to alleviate inflammatory process and reach an appropriate time for elective surgery in patients with high operative risk or marked local inflammation or organ dysfunction. Also preoperative endoscopic retrograde cholangiopancreatography (ERCP) is often needed because common bile duct (CBD) stone is accompanied in patients with acute cholecystitis at reported rate from 7-20%.
Two-steps approach of percutaneous transhepatic GB drainage (PTGBD) followed by ERCP or vice versa has been performed for the treatment of acute cholecystitis with concomitant CBD stone who are not suitable for urgent cholecystectomy. However single-step drainage of CBD and GB through ERCP and endoscopic transpapillary GB drainage (ETGD) using nasocystic tube or plastic stent has alternatively been attempted in patients who have contraindications for PTGBD. In clinical practice, many endoscopists have hesitated to perform ETGD because of its relatively low technical success rate and specific concern about post-ERCP adverse event but it minimizes catheter keeping duration, and provides effective clinical improvement via physiologic route.
Currently there are scarce data on if ETGD using nasocystic tube or plastic stent are comparable in terms of clinical efficacy and safety.
- Conditions
- Cholecystitis, Acute, Common Bile Duct Calculi
- Being tested
- 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA), 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)
- Medical subject headings
- Cholecystitis, Acute, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)Device
Endoscopic
7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)Device
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic nasogallbladder drainage | Active comparator | If GB cannulation was achieved and the wire was coiled in the GB, 5 to 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA) was placed into the GB Receives: Device: 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA) |
| Endoscopic gallbladder stenting | Active comparator | If GB cannulation was achieved and the wire was coiled in the GB, 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA) was placed into the GB Receives: Device: 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Techncal success rate
This outcome was defined as successful deep GB cannulation and placement of assigned drainage device by randomization, and determined by the operator based on the fluoroscoic images of the procedures.
Measured: From the time of randomization until the time when the endoscopic procedure is ended, assessed up to 24hours
Secondary outcomes (2)
Clinical success rate
This outcome was defined as improvement of three clinical parameters of acute cholecystitis (fever, abdominal pain, leukocytosis) within 72 hours following either type of ETGD procedure, and assessed by the review of patient's mediacal records.
Measured: From the date of randomization until the date of clinical improvement (fever, leukocytosis, abdominal pain), assessed up to 72 hours
early adverse event
This outcome was defined as any procedure related event occurring between the endoscopic procedure and elective cholecystectomy, and assessed by the patient's medical records.
Measured: From the date of the randomization until the date of the elective cholecystectomy, assessed up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoo Byung Moo, Ajou University School of Medicine
- Investigators
- Byung Moo Yoo, MD, Study director, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394327
- Sponsor's protocol ID
- AJIRB-MED-MDB-11-318
- Status last verified
- Jan 2016
- First submitted
- 18 Feb 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Naso-gallbladder Drainage Versus Gallbladder Stenting Before Elective Cholecystectomy in Patients With Acute Cholecystitis and a High Suspicion of Common Bile Duct Stone; A Prospective Randomized Preliminary Study
- ClinicalTrials.gov ID
- NCT02394327
- Acronym / sponsor ID
- AJIRB-MED-MDB-11-318
- Conditions
- Cholecystitis, Acute, Common Bile Duct Calculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Mar 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.
Early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis, but temporary decompression of the gallbladder (GB) through percutaneous or endoscopic route can be required to alleviate inflammatory process and reach an appropriate time for elective surgery in patients with high operative risk or marked local inflammation or organ dysfunction. Also preoperative endoscopic retrograde cholangiopancreatography (ERCP) is often needed because common bile duct (CBD) stone is accompanied in patients with acute cholecystitis at reported rate from 7-20%.
Two-steps approach of percutaneous transhepatic GB drainage (PTGBD) followed by ERCP or vice versa has been performed for the treatment of acute cholecystitis with concomitant CBD stone who are not suitable for urgent cholecystectomy. However single-step drainage of CBD and GB through ERCP and endoscopic transpapillary GB drainage (ETGD) using nasocystic tube or plastic stent has alternatively been attempted in patients who have contraindications for PTGBD. In clinical practice, many endoscopists have hesitated to perform ETGD because of its relatively low technical success rate and specific concern about post-ERCP adverse event but it minimizes catheter keeping duration, and provides effective clinical improvement via physiologic route.
Currently there are scarce data on if ETGD using nasocystic tube or plastic stent are comparable in terms of clinical efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic nasogallbladder drainage | Active comparator | Device: 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)If GB cannulation was achieved and the wire was coiled in the GB, 5 to 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA) was placed into the GB |
| Endoscopic gallbladder stenting | Active comparator | Device: 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)If GB cannulation was achieved and the wire was coiled in the GB, 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA) was placed into the GB |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- grade II or III acute cholecystitis met Tokyo 13 diagnostic criteria
- a high suspicion of CBD stone based on laboratory and imaging study
- informed consent given.
Key exclusion criteria (2 listed)
- bilo-pancreatic malignancy or surgically altered enteric anatomy
- subsequent elective surgery is expected to be impossible even after GB decompression based on American Society of Anesthesiologist class
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 |
|---|---|---|
| 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)Endoscopic | Device | Endoscopic nasogallbladder drainage |
| 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA) | Device | Endoscopic gallbladder stenting |
Primary outcome
Techncal success rate
Time frame: From the time of randomization until the time when the endoscopic procedure is ended, assessed up to 24hours
This outcome was defined as successful deep GB cannulation and placement of assigned drainage device by randomization, and determined by the operator based on the fluoroscoic images of the procedures.
2 secondary outcomes
Clinical success rate
Time frame: From the date of randomization until the date of clinical improvement (fever, leukocytosis, abdominal pain), assessed up to 72 hours
early adverse event
Time frame: From the date of the randomization until the date of the elective cholecystectomy, assessed up to 2 weeks
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 5 Jan 2016.
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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.
Byung Moo Yoo, MD study director
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA) and 7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA) in people with Cholecystitis, Acute and Common Bile Duct Calculi, run by Ajou University School of Medicine at 1 site in South Korea.
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 5 Jan 2016. 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 South Korea. 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?
Techncal success rate (time frame: From the time of randomization until the time when the endoscopic procedure is ended, assessed up to 24hours). 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 5 Jan 2016.