UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045104 |
|---|---|
| Receipt number | R000051346 |
| Scientific Title | Pyloroplasty vs No Intervention in Gastric Remnant Reconstruction after Oesophagectomy |
| Date of disclosure of the study information | 2021/08/24 |
| Last modified on | 2024/02/18 22:25:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pyloroplasty vs No Intervention in Gastric Remnant Reconstruction after Oesophagectomy
Acronym
GAREREO study
Scientific Title
Pyloroplasty vs No Intervention in Gastric Remnant Reconstruction after Oesophagectomy
Scientific Title:Acronym
PYNI GAREREO study
Region
| Japan |
Condition
Condition
esophageal cancer and esophagogastric junction cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Esophagectomy and reconstruction are necessary for radical treatment for esophageal cancer or esophagogasritc junction cancer. The most common reconstruction organ is gastric remnant. Delayed pyloric outlet and pyloric stenosis was potentially caused by gastric remnant mobilization and cutting vagus nerves.
Delayed pyloric outlet might induce anastomotic leakage by negative impact pressure from gastric contents. In the long term outcome, small oral intake might worse nutritional status and result decreasing cancer immunity. However, there is no evidence of efficient ways for prevention of the delayed pyloric outlet.
For prevention of pyloric stenosis and/or delayed pyloric outlet after esophagectomy, we routinely perform pyloroplasty; modified Horsley method. The object is analysis for clinical efficiency of postoperative oral intake and nutritional status by modified Horsley pyloroplasty method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
body weight change at postoperative 6 month
Key secondary outcomes
Nutritional status(body composition, laboratory data),gastric outlet tube amount, pH and billirubin of gastric outlet tube, oral intake energy, timing of enteral tube removal, pyloric outlet evaluation on postoperative day 7, perioperative complications, quetionare for gastrointestinal symptoms, recurrence free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In the esophagectomy and gastric remnant reconstruction, we perfumed new pyroloplasty; modified Horsley.
Interventions/Control_2
No pyroloplasty
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Reconstruction by the posterior sternal route
2. No previous laparotomy with high degree of adhesion (e.g., traumatic incision for trauma surgery, duodenal ulcer perforation, or gastrectomy)
3.Age of over 18 years at the time of providing informed consent
4. Eastern Cooperative Oncology Group performance status of 0 or 1
5.Treatment by thoracoscopic or robot-assisted thoracic MIE
6. Abdominal operation by manual laparoscopy or laparoscopy
7. Anastomosis by the cervical anastomosis technique
8. Full understanding of the study and voluntary provision of written consent to participate in the study
Key exclusion criteria
1. Swallowing problems and poor oral intake associated with swallowing dysfunction
2. Weight loss of over 20 percentage within 6 months before surgery
3. Any synchronous active advanced cancer or diseases that affect the nutritional status
4. Medical history of DGE
5. Simultaneous resection for gastric cancer, other pyloroplasty procedures, for example, finger bougie technique, Heineke Mikulicz strictureplasty, or botulinum toxin injection, or Roux en Y reconstruction during the trial
6. Clinical condition inappropriate for participation in this study as judged by patient's physician
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kinoshita |
Organization
Teine Keijinkai Hospital
Division name
Department of Surgery & Center of Esophageal Center
Zip code
006-8555
Address
1-40 Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL
+81-11-681-8111
okada-na@keijinkai.or.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Okada |
Organization
Teine Keijinkai Hospital
Division name
Department of Surgery & Center of Esophageal Center
Zip code
006-8555
Address
1-40 Maeda, Teine-ku, Sapporo, Hokkaido, Japan
TEL
+81-11-681-8111
Homepage URL
okada-na@keijinkai.or.jp
Sponsor or person
Institute
Teine Keijinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Teine Keijinkai Hospital clinical research and clinical trial office
Address
1-40 Maeda, Teine-ku, Sapporo, Hokkaido, Japan
Tel
+81-11-681-8111
tkh-edures@keijinkai.or.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
| 2021 | Year | 08 | Month | 24 | 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
| 2021 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 09 | Day |
Last modified on
| 2024 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051346
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
