Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05731388
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-02
First Post:
2022-10-28
Brief Title:
Assessing Depth of Small Bowel Insertion at Push Enteroscopy by Using Capsule Endoscopy
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
Assessing Depth of Small Bowel Insertion at Push Enteroscopy by Using Capsule Endoscopy to Determine Best Diagnostic Approach for Patients With Obscure Gastrointestinal Bleeding
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
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:
Bleeding from the gastrointestinal tract can originate from the small bowel Typically upper and lower endoscopies are unable to identify the site of bleeding and patients need to undergo special endoscopies with longer cameras to examine the small bowel and find the bleeding site One of the most commonly used scopes to investigate the first part of the small intestinal is called push enteroscopy This is an upper endoscopy that uses a pediatric colonoscope which is longer To date it is unknown what percentage of small bowel can be observed with this technique Hence this study aimed to determine the extent of small bowel examined by push enteroscopy Consecutive patients with suspected bleeding from the small intestine will undergo a push enteroscopy and the depth of the examination will be marked with metallic clips Subsequently patients will have a capsule endoscopy which is a little camera that will take multiple pictures of the whole small intestine The percentage of small bowel that the push enteroscopy examined will be determined by the percentage of small bowel corresponding to the location of the clips visualized on capsule endoscopy
Detailed Description:
Consecutive adult patients aged 18 years referred to a single tertiary referral center for investigation of OGIB will be prospectively recruited Patients will be included if they had overt signs of GI bleeding hematochezia or melena with an associated drop in hemoglobin or occult signs of GI bleeding in the form of persistent or recurrent iron deficiency anemia and had undergone esophagogastroduodenoscopy EGD and colonoscopy that were negative for a source of bleeding Exclusion criteria include significant cardiopulmonary disease an implanted electromedical device pregnancy previous gastrectomy extensive Crohns disease with suspicion for stricturing or fistulizing small bowel disease All patients will provide informed consent before enrollment
The study protocol was approved by the Institutional Review Board IRB at our institution and was conducted in accordance with ethical guidelines of the Helsinki Declaration Procedures Patients will undergo bowel preparation by oral ingestion of 2L of polyethylene glycol solution 12 hours before the study Push enteroscopy PE will be performed in an endoscopy theater with patients under conscious sedation using intravenous injections of midazolam 005-01mgkg and fentanyl 1-2 mcgkg with dimenhydrinate 25-50mgbody added in the case of insufficient sedation Cardiorespiratory function will be monitored during the procedure Antiplatelet and anticoagulant medications will be discontinued 3-7 days before the procedure No intravenous antispasmodic will be used during the PE in efforts to preserve normal gut motility for the passage of the subsequent capsule endoscopy CE A pediatric colonoscope furnished with a water-jet system PCF-TYPE H190L Olympus Co Tokyo Japan and distal transparent attachment cap will be inserted through the mouth and be advanced as far as possible into the small bowel using a water immersion technique and aided by multiple reduction maneuvers No overtube will be used and carbon dioxide will be used for insufflation in all cases Two endoscopic clips SureClip Micro-Tech Co Nanjin China will be placed at the maximal distal insertion point to mark this location for identification by CE The endoscope will be then withdrawn gradually as per our standard practice for direct examination of the small bowel traversed by the PE The presence of any vascular or non-vascular lesions will be recorded and endoscopic treatments such as argon plasma coagulation APC endoscopic clips or biopsies will be performed as clinically appropriate depending on the nature of the lesions found In particular the number of vascular lesions seen and how many of these lesions were treated with APC will be recorded After PE is completed the capsule PillCam TM SB3 capsule Medtronic Dublin Ireland synchronized with the recording device will be deployed into the first part of the duodenum by using a gastroscope GIF-HQ190 Olympus Tokyo Japan and capsule deployment device AdvanCE Endoscope Delivery Device STERIS OH USA Capsule recording devices will be retrieved 8-12 hours after capsule deployment and images read by two separate endoscopists trained in reporting CE CE recordings will be reviewed using the RAPID 80 software The location of the clip placed at the deepest insertion point of the PE as seen by CE will be quantified by the percentage of small bowel progress SBP and small bowel transit time SBTT from the duodenal bulb to the clip relative to the entire length of the small intestine from the duodenal bulb to the cecum Any bleeding lesions and their respective locations will also be recorded Furthermore the number of angioectasias treated during PE that were seen again on CE will be recorded to calculate the detection rates of these lesions
The primary outcome of the study is to estimate the proportion of the small intestine that can be evaluated by using the PE technique Secondary outcomes include the diagnostic yield of CE and PE in identifying the cause of obscure gastrointestinal bleeding comparison of the detection rates between the two modalities and adverse events related to these procedures Statistical analyses will be performed using JMP Pro 15 SAS Institute Cary NC USA Continuous variables will be expressed as a mean with standard deviation SD or 95 confidence interval CI or median with interquartile range IQR according to distribution
The study protocol was approved by the Institutional Review Board IRB at our institution and was conducted in accordance with ethical guidelines of the Helsinki Declaration Procedures Patients will undergo bowel preparation by oral ingestion of 2L of polyethylene glycol solution 12 hours before the study Push enteroscopy PE will be performed in an endoscopy theater with patients under conscious sedation using intravenous injections of midazolam 005-01mgkg and fentanyl 1-2 mcgkg with dimenhydrinate 25-50mgbody added in the case of insufficient sedation Cardiorespiratory function will be monitored during the procedure Antiplatelet and anticoagulant medications will be discontinued 3-7 days before the procedure No intravenous antispasmodic will be used during the PE in efforts to preserve normal gut motility for the passage of the subsequent capsule endoscopy CE A pediatric colonoscope furnished with a water-jet system PCF-TYPE H190L Olympus Co Tokyo Japan and distal transparent attachment cap will be inserted through the mouth and be advanced as far as possible into the small bowel using a water immersion technique and aided by multiple reduction maneuvers No overtube will be used and carbon dioxide will be used for insufflation in all cases Two endoscopic clips SureClip Micro-Tech Co Nanjin China will be placed at the maximal distal insertion point to mark this location for identification by CE The endoscope will be then withdrawn gradually as per our standard practice for direct examination of the small bowel traversed by the PE The presence of any vascular or non-vascular lesions will be recorded and endoscopic treatments such as argon plasma coagulation APC endoscopic clips or biopsies will be performed as clinically appropriate depending on the nature of the lesions found In particular the number of vascular lesions seen and how many of these lesions were treated with APC will be recorded After PE is completed the capsule PillCam TM SB3 capsule Medtronic Dublin Ireland synchronized with the recording device will be deployed into the first part of the duodenum by using a gastroscope GIF-HQ190 Olympus Tokyo Japan and capsule deployment device AdvanCE Endoscope Delivery Device STERIS OH USA Capsule recording devices will be retrieved 8-12 hours after capsule deployment and images read by two separate endoscopists trained in reporting CE CE recordings will be reviewed using the RAPID 80 software The location of the clip placed at the deepest insertion point of the PE as seen by CE will be quantified by the percentage of small bowel progress SBP and small bowel transit time SBTT from the duodenal bulb to the clip relative to the entire length of the small intestine from the duodenal bulb to the cecum Any bleeding lesions and their respective locations will also be recorded Furthermore the number of angioectasias treated during PE that were seen again on CE will be recorded to calculate the detection rates of these lesions
The primary outcome of the study is to estimate the proportion of the small intestine that can be evaluated by using the PE technique Secondary outcomes include the diagnostic yield of CE and PE in identifying the cause of obscure gastrointestinal bleeding comparison of the detection rates between the two modalities and adverse events related to these procedures Statistical analyses will be performed using JMP Pro 15 SAS Institute Cary NC USA Continuous variables will be expressed as a mean with standard deviation SD or 95 confidence interval CI or median with interquartile range IQR according to distribution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None