Obstructive JaundiceNCT01321203
Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)
An observational study of Obstructive Jaundice, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
To assess the safety and efficacy of CO2 insufflations during ERCP 1. Primary objective: To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Jaundice
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2010to Mar 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population age group 18yrs and above
Who may be able to join
- All consecutive adult patients referred for ERCP to AIG Hyderabad
Who cannot join
- Age < 18 years old excluded from the study.
- Patients with COPD.
- Patients with poor ejection fractions and decompensated heart failure.
- Patients with acute illness that require emergency ERCP and not fit for pre procedure and post procedure assessments.
- Patients with recent endoscopic procedure within 24 hours.
- Patient with history of recent surgery within 7 days of duration.
- Pregnant patients.
- Patients not keen to give consent for the study.
Trial locations and contacts
1 site in 1 country.
India1 site
Asian Institute Of Gastroenterology India
Hyderabad, Andhra Pradesh, 500082
About this study
Official title: A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).
To assess the safety and efficacy of CO2 insufflations during ERCP
- Primary objective: To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group.
- Secondary objective:
Endoscopist:
- To assess the adequacy of bowel distension for adequate luminal visualization
- To assess the peristaltic movement during the ERCP
Anesthetist:
- To measure the PCO2 level in patient post procedure.
- To assess the amount of sedation required during the procedure.
- To assess saturation and vital signs through out the procedure.
- To assess requirement of buscopan.
Read the detailed description
mentioned in complete
- Conditions
- Obstructive Jaundice
- Keywords
- carbon dioxide insufflation
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group-A, use of air; | Not described | |
| Group-B use of CO2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort post ERCP
the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )
Measured: 1 hour
Secondary outcomes (1)
Abdominal distention prior and post ERCP
The abdominal girth was measured prior to patient shifted to ERCP table. The immdiately post ERCP the abdominal girth measured. A fixed point is marked at the umblical regiem to maintain the site of abdominal girth.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive JaundiceStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Investigators
- Saravanan Arjuanan, MD, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321203
- Sponsor's protocol ID
- AIG-GI2010-02
- Status last verified
- Jul 2011
- First submitted
- 28 Jan 2011
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).
- ClinicalTrials.gov ID
- NCT01321203
- Acronym / sponsor ID
- AIG-GI2010-02
- Conditions
- Obstructive Jaundice
- Keywords
- carbon dioxide insufflation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Mar 2011 (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.
To assess the safety and efficacy of CO2 insufflations during ERCP
- Primary objective: To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group.
- Secondary objective:
Endoscopist:
- To assess the adequacy of bowel distension for adequate luminal visualization
- To assess the peristaltic movement during the ERCP
Anesthetist:
- To measure the PCO2 level in patient post procedure.
- To assess the amount of sedation required during the procedure.
- To assess saturation and vital signs through out the procedure.
- To assess requirement of buscopan.
Detailed description
mentioned in complete
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A, use of air; | – | – |
| Group-B use of CO2 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population age group 18yrs and above
Key inclusion criteria (1 listed)
- All consecutive adult patients referred for ERCP to AIG Hyderabad
Key exclusion criteria (8 listed)
- Age < 18 years old excluded from the study.
- Patients with COPD.
- Patients with poor ejection fractions and decompensated heart failure.
- Patients with acute illness that require emergency ERCP and not fit for pre procedure and post procedure assessments.
- Patients with recent endoscopic procedure within 24 hours.
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
Patient comfort post ERCP
Time frame: 1 hour
the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )
1 secondary outcome
Abdominal distention prior and post ERCP
Time frame: 5 minutes
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 19 Jul 2011.
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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.
Saravanan Arjuanan, MD principal investigator
Asian Institute of Gastroenterology, India
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 Obstructive Jaundice, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 8 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 19 Jul 2011. 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 India. 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?
Patient comfort post ERCP (time frame: 1 hour). 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 19 Jul 2011.