UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024441 |
|---|---|
| Receipt number | R000028130 |
| Scientific Title | Endoscopic evaluation for predicting the complications related to gastric conduit after esophagectomy |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2023/04/23 10:31:58 |
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Basic information
Public title
Endoscopic evaluation for predicting the complications related to gastric conduit after esophagectomy
Acronym
Endoscopic Evaluation After Esophagectomy
Scientific Title
Endoscopic evaluation for predicting the complications related to gastric conduit after esophagectomy
Scientific Title:Acronym
Endoscopic Evaluation After Esophagectomy
Region
| Japan |
Condition
Condition
Malignant or end-stage benign esophageal disease.
Classification by specialty
| Psychosomatic Internal Medicine | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The classification of gastric conduit ischemia by endoscopic findings predicts the major complications of gastric conduit (strictures, leakage, necrosis)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Malignant or end-stage benign esophageal disease.
Esophagectomy with reconstruction by a gastric pull-up.
Key exclusion criteria
Severe heart failure and pulmonary dysfunction
Severe renal and liver dysfunction
Allergenic history
Pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Eguchi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
8528501
Address
sakamoto 1-7-1
TEL
0958197316
skobayashi1980@gmail.com
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Kobayashi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
8528501
Address
sakamoto 1-7-1
TEL
095-819-7316
Homepage URL
shinichirokobayashi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Clinical research center, Hagasaki university hospital
Address
Sakamoto 1-7-1, Nagasaki city
Tel
095-819-7726
gaibushikin@ml.nagasaki-u.ac.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
| 2017 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00423-023-02783-x
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00423-023-02783-x
Number of participants that the trial has enrolled
58
Results
A greater than 2/3 circumference and lesion length greater than 20 mm of anastomotic ischemic area on POD 1 were associated with developing anastomotic leakage after esophagectomy OR:14.5; 95% CI:1.8-306.5; P = 0.03, OR:19.4; 95% CI: 1.7-536.8; P = 0.03.
Results date posted
| 2023 | Year | 04 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The clinical characteristics of the 58 patients, which included 9 females and 49 males, are summarized in Table 1. The median age of all patients was 68.0 years (IQR 62.8 - 73.0). Preoperative chemotherapy was performed in 39 patients (67.2%). MIE was performed in 54 patients (93.1%). Necklymphodectomy was performed in 33 patients (56.9%). The average operating time was 506 min (IQR 453 - 592). The median estimated blood loss was 160 g(IQR 103 - 273). Fifteen patients (25.9%) developed anastomotic complications related to gastric conduit reconstruction after esophagectomy. Anastomotic leakage occurred in 6 patients who required drainage to manage infectious conditions. No patients died within 30 days after the operation due to anastomotic leakage. A stricture occurred in 12 patients who required endoscopic balloon dilation. Four patients developed anastomotic leakage followed by refractory esophageal strictures. The median length of the postoperative hospital stay was 22 days (IQR 17 - 30).
Participant flow
Endoscopic examinations were performed by one surgeon on the postoperative days (POD) 1 and 8 after esophagectomy.
Adverse events
No event
Outcome measures
The purpose of this study was to prospectively evaluate the safety and efficacy of endoscopic examinations of the anastomotic region in the acute period after esophagectomy.
Endoscopic examinations were performed on postoperative days (PODs) 1 and 8. The severity of ischemia was prospectively validated according to the endoscopic mucosal ischemic index (EMII).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Endoscopic examinations are performed at 1, 8, and 15 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated.
Management information
Registered date
| 2016 | Year | 10 | Month | 17 | Day |
Last modified on
| 2023 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028130
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