UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016949 |
|---|---|
| Receipt number | R000019668 |
| Scientific Title | Randomized control study comparing reconstruction procedures after esophagectomy -gastric tube reconstruction vs gastric tube reconstruction with duodenal diversion plus Roux-en Y anastomosis- |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2019/10/01 10:16:55 |
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Basic information
Public title
Randomized control study comparing reconstruction procedures after esophagectomy -gastric tube reconstruction vs gastric tube reconstruction with duodenal diversion plus Roux-en Y anastomosis-
Acronym
Randomized control study comparing reconstruction procedures after esophagectomy -gastric tube reconstruction vs gastric tube reconstruction with duodenal diversion plus Roux-en Y anastomosis-
Scientific Title
Randomized control study comparing reconstruction procedures after esophagectomy -gastric tube reconstruction vs gastric tube reconstruction with duodenal diversion plus Roux-en Y anastomosis-
Scientific Title:Acronym
Randomized control study comparing reconstruction procedures after esophagectomy -gastric tube reconstruction vs gastric tube reconstruction with duodenal diversion plus Roux-en Y anastomosis-
Region
| Japan |
Condition
Condition
Patients with resectable thoracic esophageal cancer who are planned to undergo esophagectomy with gastric tube reconstruction and 2 or 3 field lymphadenectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether gastric tube reconstruction with duodenal diversion plus Roux-en Y anastomosis is more effective than conventional gastric tube reconstruction in preventing postoperative gastroduodenal content reflux and delayed gastric emptying
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative QOL at 1year assessed by DAUGS-32 questionare
Key secondary outcomes
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
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After patients are randomly allocated to RY and Non-RY groups, RY group undergo gastric tube reconstruction with duodenal diversion plus Roux-en anastomosis.
Interventions/Control_2
After patients are randomly allocated to RY and Non-RY groups, Non-RY group undergo conventional gastric tube reconstruction after esophagectomy.
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
| Not applicable |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. histologically proven esophageal cancer by endoscopic biopsy
2. resectable cases, cT1b-3,Nany,M0 by preoperative staging,
3. preserve normal swallowing function and can eat and drink
4. 80 years old or younger
5. PS 0-2
6. Vital organ functions within 7days before entry are preserved.
7. Written informed consentis ontained from each patient.
Key exclusion criteria
1. synchronous other malignant cancer within 1 year
2. Miocardial infarction, Master two steppositive on ECG
3. preoperative respiratory test, FEV1.0 is less than 50%
4. prior chemotherapy or radiationtherapy within 6 months
5. prior gastric or intestinal resection
6. severe absorptive disturbance
7. severe postoperative complications (anastomotic leakage, ileus, intraabdominal abcess, pneumonia, etc)
8. pregnant
9. other severe co-morbidities
10. In case where surgeon judge that entry to the study is impossible.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Yano |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastroenterological Surgery
Zip code
537-8511
Address
Nakamichi 1-3-3, Higashinari-ku, Osaka
TEL
06-6972-1181
yano-ma@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Itoh |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Research Institute
Zip code
537-8511
Address
Nakamichi 1-3-3, Higashinari-ku, Osaka
TEL
06-6977-6151
Homepage URL
kbyori01@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases, IRB
Address
Nakamichi 1-3-3, Higashinari-ku, Osaka
Tel
06-6972-1181
nakatah@opho.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000019668
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_view.cgi?recptno=R000019668
Number of participants that the trial has enrolled
60
Results
Operation time and blood loss volume were higher in the RY group. Pancreatic amylase concentrations in the gastric conduit were higher in the non-RY group. Endoscopic examination showed residual gastric content in 7/17 patients in the non-RY group but in none in the RY group. QOL was significantly favorable in the RY group with regard to reflux symptoms and food passage dysfunction. Body weight changes, serum albumin levels, and peripheral blood lymphocyte counts were not significantly different.
Results date posted
| 2019 | Year | 10 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 08 | Month | 12 | Day |
Baseline Characteristics
The background characteristics of patients were not significantly different between the groups.
Participant flow
Sixty patients with thoracic esophageal cancer scheduled to undergo esophagectomy with retrosternal gastric tube reconstruction were randomly allocated to standard gastric reconstruction (non-RY, n=31) or gastric reconstruction with duodenal diversion plus Roux-en-Y anastomosis (RY, n=29) groups.
Adverse events
Incidences of postoperative complications, such as anastomotic leakage, pneumonia, ileus, and hemorrhage, did not significantly differ. Postoperative death did not occur in any group.
Outcome measures
Primary endpoint was quality of life assessed by DAUGS-32 score 1 year after surgery. Secondary endpoints were the extent of postoperative duodenal juice reflux into the gastric tube, postoperative morbidity, endoscopic findings, body weight changes, and nutritional status.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 27 | Day |
Last modified on
| 2019 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019668
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/03/28 | ③医学研究計画書（RY vs non-RY）延長.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
