UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029561 |
|---|---|
| Receipt number | R000033774 |
| Scientific Title | A randomized controlled phase III study comparing circular stapler vs modified Collard technique as esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer |
| Date of disclosure of the study information | 2017/10/16 |
| Last modified on | 2023/04/24 09:47:21 |
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Basic information
Public title
A randomized controlled phase III study comparing circular stapler vs modified Collard technique as esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer
Acronym
Comparision of esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer
Scientific Title
A randomized controlled phase III study comparing circular stapler vs modified Collard technique as esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer
Scientific Title:Acronym
Comparision of esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer
Region
| Japan |
Condition
Condition
Thoracic esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine optimal anastomosis after esophagectomy, we compare circular stapler and modified Collard technique
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Incidence of anastomotic stricture
Key secondary outcomes
Incidence of anastomotic leakage
Incidence of postoperative complication
Time of anastomosis
QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
anastomosis by circular stapler
Interventions/Control_2
modified Collard technique by linear stapler
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)thoracic esophageal cancer without infiltration to cervical esophagus
2)radical esophagectomy with lympha node dissection
3)gastric conduit reconstruction through posterior mediastinal route or retrosternal route
4)cervical anastmosis
5)ECOG Performance status 0 to 1
6)sufficient function of important organs
7)written informed consent
Key exclusion criteria
1)Salvage surgery
2)Patients performed preoperative chemoradiotherapy
3)severe complications
4)Patients judged inappropriate for the study by the physicians
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Hosoi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterological Surgery
Zip code
4640021
Address
1-1, Kanokoden, Chikusa-ku, Aichi
TEL
052-762-6111
thosoi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Hosoi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterological Surgery
Zip code
4640021
Address
1-1, Kanokoden, Chikusa-ku, Aichi
TEL
052-762-6111
Homepage URL
thosoi@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Department of Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
Department of Gastroenterological Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Hospital
Address
1-1, Kanokoden, Chikusa-ku, Aichi
Tel
052-762-6111
irb@aichi-cc.jp
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
愛知県がんセンター中央病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000033774
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000033774
Number of participants that the trial has enrolled
100
Results
Among 100 randomized patients (CS group, n =50; MC group, n =50), anastomotic strictures were observed in 18 (42%) patients in the CS group and in no patients in the MC group.
There were no significant between-group differences in anastomotic leakage (CS group, 7% vs MC group, 8%; P =0.94).
Quality of life domains of dysphagia and choking when swallowing at 3 months after surgery were significantly better in the MC group than in the CS group.
Results date posted
| 2023 | Year | 04 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In total, 157 patients were scheduled to undergo radical esophagectomy with cervical anastomosis using a gastric conduit for treatment of
thoracic esophageal cancer. Fifty-seven patients were excluded from the study because they did not meet the inclusion criteria (n = 47) or refused to participate (n = 10).
The remaining 100 patients were subsequently randomized to the CS group (n = 50) or the MC group (n = 50).
Seven patients in the CS group and 4 patients in the MC group were excluded because the primary endpoint was not available; the remaining 43 and 46 patients, respectively, were analyzed as the FAS.
Participant flow
The patients were randomly assigned (1:1) to either the CS or MC technique by the minimization method.
The patients was performed using either the CS technique or the MC technique.
The postoperative management was identical for the 2 groups.
After discharge, the patients returned for an outpatient visit once monthly for 3 months. They were thereafter examined at 3 and 6 months after surgery. Upper gastrointestinal
endoscopy was routinely performed at 6 months after surgery or whenever dysphagia developed. BWL and QOL (assessed by the European Organization for Research and Treatment of Cancer QOL
questionnaires, C30 and OES18 modules) were measured before surgery and at 1, 3, and 6 months after surgery.19,20 These measurements were discontinued when recurrence was observed.
Adverse events
no special instruction
Outcome measures
The primary endpoint was the incidence of anastomotic stricture. The secondary endpoints included the incidence of postoperative complications(including anastomotic leakage) and quality of life (QoL).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 28 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 15 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033774
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