UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057262 |
|---|---|
| Receipt number | R000065455 |
| Scientific Title | A Retrospective Study on the Utility of Mechanical Gastrointestinal Anastomosis in Free Jejunal Reconstruction |
| Date of disclosure of the study information | 2025/03/11 |
| Last modified on | 2026/03/12 00:12:58 |
* 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
A Retrospective Study on the Utility of Mechanical Gastrointestinal Anastomosis in Free Jejunal Reconstruction
Acronym
A Retrospective Study on the Utility of Mechanical Gastrointestinal Anastomosis in Free Jejunal Reconstruction
Scientific Title
A Retrospective Study on the Utility of Mechanical Gastrointestinal Anastomosis in Free Jejunal Reconstruction
Scientific Title:Acronym
A Retrospective Study on the Utility of Mechanical Gastrointestinal Anastomosis in Free Jejunal Reconstruction
Region
| Japan |
Condition
Condition
Free Jejunal Reconstruction
Classification by specialty
| Gastrointestinal surgery | Oto-rhino-laryngology | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the utility of mechanical anastomosis by comparing the group that underwent mechanical anastomosis with the group that underwent hand-sewn anastomosis in free jejunal reconstruction following total pharyngolaryngoesophagectomy, with the primary evaluation criteria being the incidence of anastomotic stenosis on the cervical esophageal side, the number of reoperations, and the assessment of swallowing function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The incidence of anastomotic stenosis, the number of reoperations, and the assessment of swallowing function in cervical esophageal anastomosis beyond 6 months postoperatively.
Key secondary outcomes
The number of anastomotic leaks, cervical abscesses, cervical fistulas, cerebrocardiovascular complications, and cases of cervical skin necrosis; dietary status beyond 6 months postoperatively; Functional Oral Intake Scale (FOIS); the number of cases with nasal regurgitation symptoms and dysphagia symptoms; and the number of endoscopic dilatation procedures performed
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who meet all of the following selection criteria will be included in the study:
(1) Patients who underwent free jejunal reconstruction following total pharyngolaryngoesophagectomy at our institution between January 1, 2014, and November 30, 2024.
(2) Age: 18 years or older.
(3) Gender: Not specified.
(4) Patients who did not opt out and did not refuse participation in the study.
Key exclusion criteria
Individuals who meet any of the following exclusion criteria will be excluded from the study:
(1) Individuals deemed inappropriate for participation in this study by the principal investigator or researchers.
(2) Individuals who have refused to participate in the study.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Haruyuki |
| Middle name | |
| Last name | Hirayama |
Organization
The Jikei University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
105-8461
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
+81-334331111
haruyuki.hirayama@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Haruyuki |
| Middle name | |
| Last name | Hirayama |
Organization
The Jikei University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
105-8461
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
+81-334331111
Homepage URL
https://jikei.bvits.com/rinri/Common/document.aspx?ID=30905&VERSION=7&DOC_TYPE=7&PDF=1
haruyuki.hirayama@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
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
The Jikei University School of Medicine, research ethics committee
Address
3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
+81-334331111
rinri@jikei.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
東京慈恵会医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1002/ohn.70090
Number of participants that the trial has enrolled
28
Results
The overall postoperative complication rate within 30 days was similar between the mechanical stapler group and the hand-sewn group. However, operative time was significantly shorter in the mechanical stapler group. In addition, nasal regurgitation occurred less frequently in the mechanical stapler group compared with the hand-sewn group.
Results date posted
| 2026 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 12 | Month | 17 | Day |
Baseline Characteristics
Participants were 28 adult patients who underwent free jejunal transfer following total pharyngolaryngectomy at a single institution between January 2014 and September 2020. Patients were divided into a mechanical stapler group (n = 12) and a hand-sewn technique group (n = 16). Baseline characteristics included age, sex, body mass index, pathological tumor category, pathological node category, preoperative radiotherapy, neck dissection, blood loss, and operative time.
Participant flow
Among 104 patients who underwent total pharyngolaryngectomy during the study period, reconstruction with a free jejunal flap was performed in 28 patients. These patients were divided into a mechanical stapler group (n = 12) and a hand-sewn technique group (n = 16). Postoperative complications within 30 days were evaluated in all 28 patients. Functional outcomes at 6 months or more after surgery were evaluated in 18 patients (mechanical stapler: n = 8; hand-sewn: n = 10), while 10 patients were lost to follow-up.
Adverse events
Postoperative complications within 30 days after surgery were evaluated. One case of lymphorrhea occurred in the mechanical stapler group. In the hand-sewn technique group, one case of internal jugular vein thrombosis and one case of cerebrovascular complication (cerebral infarction) were observed. No cases of flap vascular compromise, flap loss, hematoma, cervical esophagojejunal anastomotic leak, pharyngocutaneous fistula, or death were observed in either group.
Outcome measures
Postoperative complications within 30 days after surgery and functional outcomes at or beyond 6 months after surgery, including the Functional Oral Intake Scale (FOIS), nasal regurgitation, symptoms of dysphagia, and anastomotic stricture.
Plan to share IPD
No.
IPD sharing Plan description
No.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The subjects of this study are patients who have undergone free jejunal reconstruction following total pharyngolaryngoesophagectomy. Since it is not feasible to obtain individual consent from each participant, information about this study will be made publicly available on the hospital's website. To clarify the utility of mechanical anastomosis, we will compare the group that underwent cervical esophageal anastomosis using mechanical stapling with the group that underwent hand-sewn anastomosis. This retrospective study will include patients who underwent either treatment at the Department of Plastic and Reconstructive Surgery, The Jikei University Hospital, between January 1, 2014, and November 30, 2024, and will compare early and late complications between the two groups.
Management information
Registered date
| 2025 | Year | 03 | Month | 11 | Day |
Last modified on
| 2026 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065455
