UMIN-CTR Clinical Trial

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
Email	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
Email	susomkia@medicine.psu.ac.th

Sponsor
Institute	Faculty of Medicine, Prince of Sonkla university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044119