Outcome of Carbon Dioxide Versus Air Insufflations During... | NCT01321203

Studies
Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)

NCT01321203

Sponsor

Asian Institute of Gastroenterology, India

Status

Completed

Last Update Posted

Jul 19, 2011Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Obstructive Jaundice

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jan 28, 2011

First Submission Date that Met QC Criteria

Mar 22, 2011

First Posted Date

Mar 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2011

Last Update Posted Date

Jul 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient comfort post ERCP	the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )	1 hour

Secondary Outcomes

Measure	Description	Time Frame
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.	5 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All consecutive adult patients referred for ERCP to AIG Hyderabad

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study population age group 18yrs and above

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Saravanan Arjuanan, MD	Asian Institute of Gastroenterology, India	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asian Institute Of Gastroenterology India		Hyderabad	Andhra Pradesh	500082	India

Condition Browse Module

MeSH Terms

ID	Term
D041781	Jaundice, Obstructive

Ancestor Terms

ID	Term
D007565	Jaundice
D006932	Hyperbilirubinemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Group-A, use of air;
Group-B use of CO2