UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001314 |
|---|---|
| Receipt number | R000001601 |
| Scientific Title | Randomized control trial on long-intestinal-tube insertion with the ropeway method facilitated by a guidewire placed by transnasal ultrathin endoscopy for bowel obstruction |
| Date of disclosure of the study information | 2008/08/15 |
| Last modified on | 2008/08/15 13:23:45 |
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Basic information
Public title
Randomized control trial on long-intestinal-tube insertion with the ropeway method facilitated by a guidewire placed by transnasal ultrathin endoscopy for bowel obstruction
Acronym
Randomized control trial on long-intestinal-tube insertion with the ropeway method facilitated by a guidewire placed by transnasal ultrathin endoscopy for bowel obstruction
Scientific Title
Randomized control trial on long-intestinal-tube insertion with the ropeway method facilitated by a guidewire placed by transnasal ultrathin endoscopy for bowel obstruction
Scientific Title:Acronym
Randomized control trial on long-intestinal-tube insertion with the ropeway method facilitated by a guidewire placed by transnasal ultrathin endoscopy for bowel obstruction
Region
| Japan |
Condition
Condition
small bowel obstruction
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bowel obstruction, which is caused by various diseases, can follow a critical course, such as rupture of the intestine, sepsis, and multi-organ failure, without adequate treatment. A long tube is placed for the purpose of decompression of the obstructed intestine by aspiration of the intestinal contents, leading to favorable outcomes including a decrease in edema, improvement of the circulation of the involved intestine, and correction of intestinal kinking.
Although long-tube insertion is widely used in clinical practice, it is sometimes difficult to intubate the small bowel with a long tube, resulting in long procedure time, severe patient distress, and increased exposure to X-ray when the procedure is performed under fluoroscopy.
We conducted a prospective randomized controlled trial to evaluate a novel technique for long-tube insertion, namely, a ropeway method employing a guidewire, placed by transnasal ultrathin endoscopy, in the treatment of bowel obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the time required by the procedure until the long tube passed through the duodenojejunal flexure in successful cases
Key secondary outcomes
the success rate, the total procedure time, the total X-ray exposure time, the intensity of patient distress on a visual analogue scale of 1 to 5, and complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ILTR (Intervention group):
For local anesthesia, application of a nose drop of naphazolone nitrate and spraying of a mixture of 4% lidocain and 0.1% epinephrine solution (9:1) to the nostrils were performed. Diazepam and/or pentazocine were administered as necessary. The scope (GIF-XP260N; Olympus, Tokyo, Japan) was inserted transnasally with the patient in the left lateral decubitus position. For insertion of the long tube, the patient was kept in the supine position. After aspiration of fluid and air in the stomach via its working channel, the scope was advanced to the duodenum. A guidewire (Jagwire, 0.035 inch, 450 cm long; Boston Scientific, U.S.A) was then inserted via the working channel of the scope into the small bowel beyond the duodenojejunal flexure, which was confirmed fluoroscopically. The scope was withdrawn while the guidewire was kept in place. The guidewire was passed through the tip hole of the long tube (Hydrophilic long tube; Create Medic, Tokyo, Japan) to the most distal side hole (4 cm from the tip). In order to reduce patient pain and friction between the tube and its pathway, lidocain jelly was applied to the tube, and the tube with a splinting guidewire (Create Medic, 1.24 mm, 3500 mm-long) was gently inserted into the naris. When the tube reached the small intestine, the guidewire for guidance was removed and the tube was advanced as anally as possible to the dilated bowel with postural change of the patient and transabdominal manipulation. Finally, the positioning balloon was inflated and the splinting guidewire was withdrawn.
Interventions/Control_2
Conventional long-tube insertion under fluoroscopy (Control group):
In the conventional method, a long tube was inserted under fluoroscopic guidance without endoscopy. When intubation of the small bowel was unsuccessful even with postural change of the patient and transabdominal manipulations, a conventional endoscope for esophagogastroduodenoscopy was inserted perorally to facilitate passage of the tube through the pylorus. Insertion of the tube as deep as possible was attempted even after it had reached the duodenojejunal flexure.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who had been diagnosed as suffering from bowel obstruction requiring decompression with a long tube placement
Key exclusion criteria
(1) those who had undergone previous gastrectomy, (2) those with contraindications for placement of a long tube such as previous otorhinolaryngological or esophageal diseases, (3) class IV patients as defined by the American Society of Anesthesiologists, (4) pregnant patients, (5) those younger than 18 years of age, and (6) those with a possible risk of aspiration during the procedure.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihide Kanno |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL
022-252-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihide Kanno |
Organization
Sendai City Medical Center
Division name
Department of Gastroenterology
Zip code
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL
022-252-1111
Homepage URL
Sponsor or person
Institute
Sendai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
single center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The mean (+/- SD) duration of the procedure in the successful cases in the ILTR group and the C group was 16.1 +/- 5.6 minutes and 26.4 +/- 13.8 minutes, respectively (P = 0.010). The success rate was 100% in the ILTR group and 88% in the C group (P = 0.48). The mean X-ray exposure time and intensity of patient distress were 16.4 +/- 8.7 minutes vs. 33.2 +/- 12.3 minutes (P < 0.001) and 2.6 +/- 0.7 vs. 3.7 +/- 1.2 (P = 0.016), respectively.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 15 | Day |
Last modified on
| 2008 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001601
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| Registered date | File name |
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