UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038698 |
|---|---|
| Receipt number | R000044119 |
| Scientific Title | Esophageal dilation and percutaneous endoscopic gastrostomy: RCT study between intravenous sedation vs general anesthesia |
| Date of disclosure of the study information | 2019/11/27 |
| Last modified on | 2019/11/27 16:03:56 |
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Basic information
Public title
Esophageal dilation and percutaneous endoscopic gastrostomy: RCT study between intravenous sedation vs general anesthesia
Acronym
Esophageal dilation and percutaneous endoscopic gastrostomy: RCT study between intravenous sedation vs general anesthesia
Scientific Title
Esophageal dilation and percutaneous endoscopic gastrostomy: RCT study between intravenous sedation vs general anesthesia
Scientific Title:Acronym
Esophageal dilation and percutaneous endoscopic gastrostomy: RCT study between intravenous sedation vs general anesthesia
Region
| Asia(except Japan) |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Most of esophageal cancer patients have dysphagia and weight loss from tumor obstruction. The NCCN guidelines suggest percutaneous endoscopic gastrostomy (PEG) feeding before neoadjuvant or definitive chemoradiotherapy.1 Previously, general anesthesia is used for most patients who undergo esophageal dilation (with Savary-Gilliard dilators) and percutaneous endoscopic gastrostomy in esophageal cancer. Recently, intravenous sedation with local anesthesia is accepted as another option. In Songklanagarind Hospital, we have performed both techniques up to surgeon preference. However, no study was compared between both techniques. We wanted to determine whether these procedures could be performed with similar results and cost under intravenous sedation with local anesthesia versus general anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total procedure time (from the time patient arrived in the operating room to the time the patient left) and actual procedure time (from endoscopy to wound closure) are recorded. Patients are reevaluated at 24 hours, 2 weeks, and 30 days after the procedure for postoperative complications and outcomes. Length of hospitalization after the procedure is also recorded. These charges are converted to cost and then analyzed. We only calculate the cost for the procedure and not that for total hospitalization. The cost is analyzed from the perspective of the hospital.
Key secondary outcomes
The cost is analyzed from the perspective of the hospital.
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
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
GA
Interventions/Control_2
IV
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
| 20 | years-old | < |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
esophageal cancer
Key exclusion criteria
benign disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Somkiat |
| Middle name | |
| Last name | Sunpaweravong |
Organization
Department of Surgery, Faculty of Medicine, Prince of Sonkla university
Division name
general surgery
Zip code
90110
Address
Hat Yai, Songkhla, Thailand
TEL
66869663780
susomkia@medicine.psu.ac.th
Public contact
Name of contact person
| 1st name | Somkiat |
| Middle name | |
| Last name | Sunpaweravong |
Organization
Department of Surgery, Faculty of Medicine, Prince of Sonkla university
Division name
general surgery
Zip code
90110
Address
Hat Yai, Songkhla, Thailand
TEL
66869663780
Homepage URL
susomkia@medicine.psu.ac.th
Sponsor or person
Institute
Faculty of Medicine, Prince of Sonkla university
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Prince of Sonkla university
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Prince of Sonkla university
Address
Hat Yai, Songkhla, Thailand
Tel
6674455000
medpsu.ec@gmail.com
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
| 2019 | Year | 11 | Month | 27 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 27 | Day |
Last modified on
| 2019 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044119
