NCT01321203

Brief Summary

To assess the safety and efficacy of CO2 insufflations during ERCP

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
Last Updated

July 19, 2011

Status Verified

July 1, 2011

Enrollment Period

7 months

First QC Date

January 28, 2011

Last Update Submit

July 16, 2011

Conditions

Obstructive Jaundice

Keywords

carbon dioxide insufflation

Outcome Measures

Primary Outcomes (1)

  • Patient comfort post ERCP

    the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )

    1 hour

Secondary Outcomes (1)

  • Abdominal distention prior and post ERCP

    5 minutes

Study Arms (2)

Group-A, use of air;

Group-B use of CO2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population age group 18yrs and above

You may qualify if:

  • All consecutive adult patients referred for ERCP to AIG Hyderabad

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institute Of Gastroenterology India

Hyderabad, Andhra Pradesh, 500082, India

Location

MeSH Terms

Conditions

Jaundice, Obstructive

Condition Hierarchy (Ancestors)

JaundiceHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Saravanan Arjuanan, MD

    Asian Institute of Gastroenterology, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2011

First Posted

March 23, 2011

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 19, 2011

Record last verified: 2011-07

Locations

IN(1)