UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054597 |
|---|---|
| Receipt number | R000062207 |
| Scientific Title | A Prospective Observational Study on Characteristic Endoscopic Findings in Anastomotic Leakage after Esophagectomy |
| Date of disclosure of the study information | 2024/06/06 |
| Last modified on | 2024/06/06 22:33:33 |
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Basic information
Public title
A Prospective Observational Study on Characteristic Endoscopic Findings in Anastomotic Leakage after Esophagectomy
Acronym
A Observational Study on Characteristic Endoscopic Findings in Anastomotic Leakage after Esophagectomy
Scientific Title
A Prospective Observational Study on Characteristic Endoscopic Findings in Anastomotic Leakage after Esophagectomy
Scientific Title:Acronym
A Observational Study on Characteristic Endoscopic Findings in Anastomotic Leakage after Esophagectomy
Region
| Japan |
Condition
Condition
Esophageal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
One of the complications of esophagectomy performed for esophageal cancer is anastomotic leakage. If the diagnosis is delayed and the condition worsens, it can lead to fatal complications such as mediastinitis, mediastinal abscess, and sepsis. This study aims to clarify the relationship between endoscopic findings and the occurrence of anastomotic leakage by performing regular postoperative endoscopic examinations and observing the reconstructed organ from the lumen.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of anastomotic leakage
Definition of anastomotic leakage in this study: Cases where a fistula is endoscopically confirmed at the anastomotic site, and classified as Clavien-Dindo Grade II (requiring pharmacological therapy with antibiotics) or higher.
Presence of mucosal defect
Definition of mucosal defect in this study: Cases where a mucosal defect is endoscopically observed at the anastomotic site but does not meet the definition of anastomotic leakage.
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
(1) Men and women aged 20-85 diagnosed with cervical and thoracic esophageal cancer or esophagogastric junction cancer.
(2) Clinical Stage I-IVA (UICC TNM Classification 8th edition), excluding T4b.
(3) Cases undergoing thoracoscopic esophagectomy (including robot-assisted) with reconstruction using a gastric tube through the posterior mediastinal or retrosternal route, at Tohoku University Hospital, Department of General Surgery (Esophageal Surgery Group) from May 2024 to March 2026.
(4) Individuals who have provided written informed consent to participate in the study.
Key exclusion criteria
For effectiveness evaluation:
1. Cases reconstructed using the small intestine or colon, and cases reconstructed via the anterior thoracic route.
For safety evaluation:
2. Patients with allergies to medications used during endoscopic examination (e.g., Xylocaine spray, midazolam, flumazenil).
3. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
From the perspective of risk/benefit balance:
4. Patients with a history of clinically significant mental disorders or central nervous system disorders.
5. Patients deemed unsuitable for this study by the responsible (or participating) physician.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kamei |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi, Japan
TEL
+81-227177214
tkamei@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Ishida |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
TEL
+81-227177214
Homepage URL
h-ishida@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
the Ethics Committee of Tohoku University School of Medicine
Address
1-1, Seiryo-machi, Aoba-ku, Sendai-shi, Miyagi
Tel
+81-227284105
ec@rinri.hosp.tohoku.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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062207
