Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464022
Status:
COMPLETED
Last Update Posted:
2007-10-17
First Post:
2007-04-18
Brief Title:
CO2 Insufflation During Double Balloon Enteroscopy
Sponsor:
Rikshospitalet University Hospital
Organization:
Rikshospitalet University Hospital
Study Overview
Official Title:
Carbon Dioxide Versus Air Insufflation in Double-Balloon Endoscopy -a Randomised Controlled Multicentre Trial
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Double-balloon enteroscopy DBE is a novel endoscopic procedure for visualising the entire small bowel In any GI endoscopy procedure it is mandatory to insufflate gas into the bowel to secure good visualisation All endoscopes used for GI endoscopy provide a gas insufflation unit Currently air is used for this purpose in more than 90 of centres throughout the world The use of air however is far from ideal to use for insufflation in GI endoscopy After GI endoscopy significant amounts of air are usually retained in the bowel segment inspected 5 This air has to pass the GI tract and exit physiologically through the rectum Thus abdominal pain and discomfort during and after the examination due to the retention of air has been shown to be very common during and after endoscopic procedures 5-9
Carbon dioxide gas CO2 unlike air is rapidly absorbed from the bowel Within minutes several litres of CO2 can be absorbed from the GI tract The use of CO2 has been shown to result in more comfortable examinations in both colonoscopy and flexible sigmoidoscopy in several randomised trials 6-9 In these studies CO2 insufflation almost completely reduced procedure-related pain and discomfort
To our knowledge no research has been performed investigating the use of CO2 in DBE DBE is a long-lasting procedure mean examination time 75 minutes 4 Large volumes of air are insufflated during the procedure leading to significant distension of the small bowel during and after the examination
One of the main technical difficulties in DBE is the formation of small bowel loops and scarp angels during deep intubation of the endoscope These loops and angels are the major restriction to deep intubation of the endoscope Loops and scarp angels are more pronounced in air-distended bowel segments
The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in DBE patients Furthermore we want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope and thus a more complete examination of the small bowel mucosa
The study is designed as a two-centre randomised controlled trial Randomisation to the two treatment groups CO2 or air insufflation is performed on basis of the individual participant
Carbon dioxide gas CO2 unlike air is rapidly absorbed from the bowel Within minutes several litres of CO2 can be absorbed from the GI tract The use of CO2 has been shown to result in more comfortable examinations in both colonoscopy and flexible sigmoidoscopy in several randomised trials 6-9 In these studies CO2 insufflation almost completely reduced procedure-related pain and discomfort
To our knowledge no research has been performed investigating the use of CO2 in DBE DBE is a long-lasting procedure mean examination time 75 minutes 4 Large volumes of air are insufflated during the procedure leading to significant distension of the small bowel during and after the examination
One of the main technical difficulties in DBE is the formation of small bowel loops and scarp angels during deep intubation of the endoscope These loops and angels are the major restriction to deep intubation of the endoscope Loops and scarp angels are more pronounced in air-distended bowel segments
The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in DBE patients Furthermore we want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope and thus a more complete examination of the small bowel mucosa
The study is designed as a two-centre randomised controlled trial Randomisation to the two treatment groups CO2 or air insufflation is performed on basis of the individual participant
Detailed Description:
Background The small bowel has been a large blind spot for gastrointestinal GI endoscopy as until recently the small bowel was not accessible with conventional endosocopes
Double-balloon enteroscopy DBE is a novel endoscopic procedure for visualising the entire small bowel The method was first described by Yamamoto et al and May et al in 2001 and 2003 respectively 12 Since then DBE has spread to a rising number of centres around the world Both endoscopic diagnosis eg by biopsy and treatment can be easily performed using DBE The first larger series recently published demonstrate that DBE is feasible in scoping large parts of the small bowel with total small intubation possible in about 30-40 of cases 34
In any GI endoscopy procedure it is mandatory to insufflate gas into the bowel to secure good visualisation All endoscopes used for GI endoscopy provide a gas insufflation unit The gas is pumped on demand into the area examined by the endoscopist via a gas tube incorporated in the endoscope Currently air is used for this purpose in more than 90 of centres throughout the world The use of air however is far from ideal to use for insufflation in GI endoscopy After GI endoscopy significant amounts of air are usually retained in the bowel segment inspected 5 This air has to pass the GI tract and exit physiologically through the rectum Thus abdominal pain and discomfort during and after the examination due to the retention of air has been shown to be very common during and after endoscopic procedures 5-9
Carbon dioxide gas CO2 unlike air is rapidly absorbed from the bowel Within minutes several litres of CO2 can be absorbed from the GI tract The use of CO2 has been shown to result in more comfortable examinations in both colonoscopy and flexible sigmoidoscopy in several randomised trials 6-9 In these studies CO2 insufflation almost completely reduced procedure-related pain and discomfort
To our knowledge no research has been performed investigating the use of CO2 in DBE DBE is a long-lasting procedure mean examination time 75 minutes 4 Large volumes of air are insufflated during the procedure leading to significant distension of the small bowel during and after the examination
One of the main technical difficulties in DBE is the formation of small bowel loops and scarp angels during deep intubation of the endoscope These loops and angels are the major restriction to deep intubation of the endoscope Loops and scarp angels are more pronounced in air-distended bowel segments
The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in DBE patients Furthermore we want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope and thus a more complete examination of the small bowel mucosa
Hypothesis
1 The use of CO2 in DBE leads to a reduction in abdominal pain for the patient when compared with the use of air
2 The use of CO2 in DBE leads to deeper intubation when compared to air insufflation
Methods Study design The study is designed as a two-centre randomised controlled trial The participating centres are Rikshospitalet University Hospital Oslo Norway and University Hospital Muenster Germany
Randomisation to the two treatment groups CO2 or air insufflation is performed on basis of the individual participant Equally large groups are randomised using block randomisation blocks of six patients for each of the participating centres Randomisation using SPSS statistical software package is performed by an independent researcher who is not part of the DBE team
Individuals eligible for inclusion are patients referred for DBE at the trial centres who do not fulfil one of the following exclusion criteria
Age under 16 years
Inability to understand information for participation
Refusal of participation
All eligible individuals are informed about the nature of the study All individuals provide written informed consent before entering the trial Patients who do not wish to participate in the present trial are treated according to standard procedures using air insufflation
All procedures are performed by experienced endoscopists Both patients and endoscopists are blinded with regard to type of gas used for any particular patient
Sedation is performed according to current standards at the centres
Double-balloon procedure DBE is performed using the DBE endoscope system Fujinon Inc Japan as described in the literature 1-4 The DBE endoscope consist of a 200-cm long video endoscope with an outer diameter of 85 mm and a flexible overtube with a length of 145 cm and an outer diameter of 12 mm Latex balloons are attached to both the endoscope and the overtube These balloons are inflated and deflated during insertion as described elsewhere in detail 12
Gas insufflation CO2 is insufflated using Fujinons equipment or other to be specified Air is insufflated using the ordinary air inlet system of the endoscope rack The air inlet button is hidden from the view of the endoscopist to prevent unblinding technical details to be specified in cooperation with company
Evaluation of pain and discomfort A questionnaire is used to classify patient pain during and after the procedure Visual analogue scales 100-mm are used to quantify abdominal pain during the examination and at 1 3 6 and 24 hours after the procedure as validated in recent studies 78 The questionnaire is given to every participant after the procedure to be filled in the next day and mailed back to the respective trial centre using prepaid envelopes
Evaluation of ERCP examination parameters All procedure parameters of interest eg duration depth of insertion use of sedatives are registered by the endoscopist immediately after the examination using the existing GI lab databases
Ethics The regional ethics committees of the participating centres will be asked for approval of the study protocol
Power analysis A 15 reduction in mean pain score on VAS is considered to be clinically important to detect There are no studies available regarding this outcome in DBE Therefore pilot study will be performed with 20 included patients in every group airCO2 The results of the pilot study will estimate the standard deviation needed to calculate power and thus size of the study
Ownership Data are owned by the respective centres Publication of the study results is planned in a peer-reviewed journal Michael Bretthauer and Dirk Domagk will co-ordinate study design data generation and analysis and a first manuscript draft Michael Bretthauer and Dirk Domagk will be the first authors of the planned publication the other members of the study groups will be co-authors
Budget All procedures in the present study are performed in ordinary patients with ordinary staff and endoscopists Therefore no extra costs occur for personal For the purpose of the present study however some technical equipment has to be purchased to be specified
Financial funding is needed for meetings of the study group and prepaid envelopes
References
1 Yamamoto Sekine Y Saito Y et al Total enteroscopy with a non-surgical steerable double-balloon method Gatrointest Endosc 200153216-20
2 May A Nachbar L Wardak A et al Double-balloon enteroscopy preliminary experience in patients with obscure gastrointestinal bleeding or chronic abdominal pain Endoscopy 200335985-91
3 May A Nachbar L Ell C Double-balloon enteroscopy push-and-pull enteroscopy of the small bowel feasibility and diagnostic and therapeutic yield in patients with suspected small bowel disease Gastrointest Endoc 20056262-70
4 Ell C May A Nachbar L et al Push-and pull enteroscopy in the small bowel using the double-balloon technique results of a prospective European multicenter study Endoscopy 200537613-6
5 Hussein AMJ Carbon dioxide insufflation for more comfortable colonoscopy Gastrointest Endosc 1984 3068-70
6 Stevensen GW et al Pain following colonoscopy elimination with carbon dioxide Gastrointet Endosc 199238564-567
7 Bretthauer M Thiis-Evensen E Hoff G et al A randomized controlled trial to assess the safety and efficacy of carbon dioxide insufflation in colonoscopy Gut 2002 50604-607
8 Bretthauer M Hoff G Thiis-Evensen E et al Carbon dioxide insufflation reduces discomfort due to flexible sigmoidoscopy in colorectal cancer screening Scand J Gastroenterol 2002 371103-8
9 Sumanac K Zealley I Fox B et al Minimizing postcolonoscopy abdominal pain by using CO2 insufflation a prospective randomized double blind controlled trial evaluating a new commercially available CO2 delivery system Gastrointest Endosc 200256190-4
Information and consent Research study Insuflation of carbon dioxideCO2 in double balloon enteroscopy
Dear patient
You are hereby kindly invited to participate in a research study while undergoing your planned endoscopic investigation of the small bowel DBE double balloon enteroscopy
During this examination it is common practice to insufflate gas into the small bowel to provide the examiner with an adequate view At the vast majority of hospitals around the world ordinary room air is used for insufflation However the insufflated air can produce pain and abdominal discomfort for patients during and in the hours after the examination
There is some evidence that the use of carbon dioxide gas CO2 instead of air can reduce abdominal pain after examination In this study we would like to find out if this is true
Study participants will be divided by random into a group that receives CO2 during the DBE examination and one group that receives air
Both the endoscopist and you as a patient do not know which gas is being used Only the endoscopy assistant knows the type of gas used during your examination After the examination you will receive a short questionnaire about any complaints or discomfort which we would like to ask you to fill in at home and mail back to the hospital
If you decide not to participate in the study your examination will be performed with the use of air insufflation standard method
The present study has been approved by the ethics committee All information will be treated strictly confidential and only for research purposes within this study Participation is free of charge and not mandatory You may decline your participation at any time
Yours sincerely
Dr med Michael Bretthauer tlf
Written informed consent I hereby declare my participation in the abovementioned research study I am aware of that participation is voluntary
Date Signature
Vedlegg C
Carbon dioxide versus air insufflation in double-balloon endoscopy
Patient questionnaire Version 300606 Michael Bretthauer
This questionnaire is to be filled in the day after the procedure and to be mailed back to the GI lab
Patient ID
1 Was the examination any painful
Please score the degree of pain with a vertical dash on the scale below between No pain left margin and very heavy pain right margin
No pain Very heavy pain
2 Did you have any abdominal pain or distension after the examination
Please score the degree of pain with a vertical dash on the scale below between No pain left margin and very heavy pain right margin
No pain Very heavy pain
1 hour after the exam
3 hours after the exam
6 hours after the exam
24 hours after the exam
Please use the back of the questionnaire for any comments
Double-balloon enteroscopy DBE is a novel endoscopic procedure for visualising the entire small bowel The method was first described by Yamamoto et al and May et al in 2001 and 2003 respectively 12 Since then DBE has spread to a rising number of centres around the world Both endoscopic diagnosis eg by biopsy and treatment can be easily performed using DBE The first larger series recently published demonstrate that DBE is feasible in scoping large parts of the small bowel with total small intubation possible in about 30-40 of cases 34
In any GI endoscopy procedure it is mandatory to insufflate gas into the bowel to secure good visualisation All endoscopes used for GI endoscopy provide a gas insufflation unit The gas is pumped on demand into the area examined by the endoscopist via a gas tube incorporated in the endoscope Currently air is used for this purpose in more than 90 of centres throughout the world The use of air however is far from ideal to use for insufflation in GI endoscopy After GI endoscopy significant amounts of air are usually retained in the bowel segment inspected 5 This air has to pass the GI tract and exit physiologically through the rectum Thus abdominal pain and discomfort during and after the examination due to the retention of air has been shown to be very common during and after endoscopic procedures 5-9
Carbon dioxide gas CO2 unlike air is rapidly absorbed from the bowel Within minutes several litres of CO2 can be absorbed from the GI tract The use of CO2 has been shown to result in more comfortable examinations in both colonoscopy and flexible sigmoidoscopy in several randomised trials 6-9 In these studies CO2 insufflation almost completely reduced procedure-related pain and discomfort
To our knowledge no research has been performed investigating the use of CO2 in DBE DBE is a long-lasting procedure mean examination time 75 minutes 4 Large volumes of air are insufflated during the procedure leading to significant distension of the small bowel during and after the examination
One of the main technical difficulties in DBE is the formation of small bowel loops and scarp angels during deep intubation of the endoscope These loops and angels are the major restriction to deep intubation of the endoscope Loops and scarp angels are more pronounced in air-distended bowel segments
The aim of the present study is to examine whether CO2 insufflation leads to a reduction of abdominal pain in DBE patients Furthermore we want to investigate if CO2 insufflation facilities a deeper intubation of the endoscope and thus a more complete examination of the small bowel mucosa
Hypothesis
1 The use of CO2 in DBE leads to a reduction in abdominal pain for the patient when compared with the use of air
2 The use of CO2 in DBE leads to deeper intubation when compared to air insufflation
Methods Study design The study is designed as a two-centre randomised controlled trial The participating centres are Rikshospitalet University Hospital Oslo Norway and University Hospital Muenster Germany
Randomisation to the two treatment groups CO2 or air insufflation is performed on basis of the individual participant Equally large groups are randomised using block randomisation blocks of six patients for each of the participating centres Randomisation using SPSS statistical software package is performed by an independent researcher who is not part of the DBE team
Individuals eligible for inclusion are patients referred for DBE at the trial centres who do not fulfil one of the following exclusion criteria
Age under 16 years
Inability to understand information for participation
Refusal of participation
All eligible individuals are informed about the nature of the study All individuals provide written informed consent before entering the trial Patients who do not wish to participate in the present trial are treated according to standard procedures using air insufflation
All procedures are performed by experienced endoscopists Both patients and endoscopists are blinded with regard to type of gas used for any particular patient
Sedation is performed according to current standards at the centres
Double-balloon procedure DBE is performed using the DBE endoscope system Fujinon Inc Japan as described in the literature 1-4 The DBE endoscope consist of a 200-cm long video endoscope with an outer diameter of 85 mm and a flexible overtube with a length of 145 cm and an outer diameter of 12 mm Latex balloons are attached to both the endoscope and the overtube These balloons are inflated and deflated during insertion as described elsewhere in detail 12
Gas insufflation CO2 is insufflated using Fujinons equipment or other to be specified Air is insufflated using the ordinary air inlet system of the endoscope rack The air inlet button is hidden from the view of the endoscopist to prevent unblinding technical details to be specified in cooperation with company
Evaluation of pain and discomfort A questionnaire is used to classify patient pain during and after the procedure Visual analogue scales 100-mm are used to quantify abdominal pain during the examination and at 1 3 6 and 24 hours after the procedure as validated in recent studies 78 The questionnaire is given to every participant after the procedure to be filled in the next day and mailed back to the respective trial centre using prepaid envelopes
Evaluation of ERCP examination parameters All procedure parameters of interest eg duration depth of insertion use of sedatives are registered by the endoscopist immediately after the examination using the existing GI lab databases
Ethics The regional ethics committees of the participating centres will be asked for approval of the study protocol
Power analysis A 15 reduction in mean pain score on VAS is considered to be clinically important to detect There are no studies available regarding this outcome in DBE Therefore pilot study will be performed with 20 included patients in every group airCO2 The results of the pilot study will estimate the standard deviation needed to calculate power and thus size of the study
Ownership Data are owned by the respective centres Publication of the study results is planned in a peer-reviewed journal Michael Bretthauer and Dirk Domagk will co-ordinate study design data generation and analysis and a first manuscript draft Michael Bretthauer and Dirk Domagk will be the first authors of the planned publication the other members of the study groups will be co-authors
Budget All procedures in the present study are performed in ordinary patients with ordinary staff and endoscopists Therefore no extra costs occur for personal For the purpose of the present study however some technical equipment has to be purchased to be specified
Financial funding is needed for meetings of the study group and prepaid envelopes
References
1 Yamamoto Sekine Y Saito Y et al Total enteroscopy with a non-surgical steerable double-balloon method Gatrointest Endosc 200153216-20
2 May A Nachbar L Wardak A et al Double-balloon enteroscopy preliminary experience in patients with obscure gastrointestinal bleeding or chronic abdominal pain Endoscopy 200335985-91
3 May A Nachbar L Ell C Double-balloon enteroscopy push-and-pull enteroscopy of the small bowel feasibility and diagnostic and therapeutic yield in patients with suspected small bowel disease Gastrointest Endoc 20056262-70
4 Ell C May A Nachbar L et al Push-and pull enteroscopy in the small bowel using the double-balloon technique results of a prospective European multicenter study Endoscopy 200537613-6
5 Hussein AMJ Carbon dioxide insufflation for more comfortable colonoscopy Gastrointest Endosc 1984 3068-70
6 Stevensen GW et al Pain following colonoscopy elimination with carbon dioxide Gastrointet Endosc 199238564-567
7 Bretthauer M Thiis-Evensen E Hoff G et al A randomized controlled trial to assess the safety and efficacy of carbon dioxide insufflation in colonoscopy Gut 2002 50604-607
8 Bretthauer M Hoff G Thiis-Evensen E et al Carbon dioxide insufflation reduces discomfort due to flexible sigmoidoscopy in colorectal cancer screening Scand J Gastroenterol 2002 371103-8
9 Sumanac K Zealley I Fox B et al Minimizing postcolonoscopy abdominal pain by using CO2 insufflation a prospective randomized double blind controlled trial evaluating a new commercially available CO2 delivery system Gastrointest Endosc 200256190-4
Information and consent Research study Insuflation of carbon dioxideCO2 in double balloon enteroscopy
Dear patient
You are hereby kindly invited to participate in a research study while undergoing your planned endoscopic investigation of the small bowel DBE double balloon enteroscopy
During this examination it is common practice to insufflate gas into the small bowel to provide the examiner with an adequate view At the vast majority of hospitals around the world ordinary room air is used for insufflation However the insufflated air can produce pain and abdominal discomfort for patients during and in the hours after the examination
There is some evidence that the use of carbon dioxide gas CO2 instead of air can reduce abdominal pain after examination In this study we would like to find out if this is true
Study participants will be divided by random into a group that receives CO2 during the DBE examination and one group that receives air
Both the endoscopist and you as a patient do not know which gas is being used Only the endoscopy assistant knows the type of gas used during your examination After the examination you will receive a short questionnaire about any complaints or discomfort which we would like to ask you to fill in at home and mail back to the hospital
If you decide not to participate in the study your examination will be performed with the use of air insufflation standard method
The present study has been approved by the ethics committee All information will be treated strictly confidential and only for research purposes within this study Participation is free of charge and not mandatory You may decline your participation at any time
Yours sincerely
Dr med Michael Bretthauer tlf
Written informed consent I hereby declare my participation in the abovementioned research study I am aware of that participation is voluntary
Date Signature
Vedlegg C
Carbon dioxide versus air insufflation in double-balloon endoscopy
Patient questionnaire Version 300606 Michael Bretthauer
This questionnaire is to be filled in the day after the procedure and to be mailed back to the GI lab
Patient ID
1 Was the examination any painful
Please score the degree of pain with a vertical dash on the scale below between No pain left margin and very heavy pain right margin
No pain Very heavy pain
2 Did you have any abdominal pain or distension after the examination
Please score the degree of pain with a vertical dash on the scale below between No pain left margin and very heavy pain right margin
No pain Very heavy pain
1 hour after the exam
3 hours after the exam
6 hours after the exam
24 hours after the exam
Please use the back of the questionnaire for any comments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None