UMIN-CTR Clinical Trial

Basic information
Public title	Disturbed passage of jejunal limb near esophageal hiatus after overlapped esophagojejunostomy following laparoscopic total gastrectomy
Acronym	Disturbed passage of jejunal limb near esophageal hiatus after overlapped esophagojejunostomy following laparoscopic total gastrectomy
Scientific Title	Disturbed passage of jejunal limb near esophageal hiatus after overlapped esophagojejunostomy following laparoscopic total gastrectomy
Scientific Title:Acronym	Disturbed passage of jejunal limb near esophageal hiatus after overlapped esophagojejunostomy following laparoscopic total gastrectomy
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Overlap esophagojejunostomy (OEJ) in laparoscopic total gastrectomy (LTG) is one of the gastrointestinal reconstruction methods that can be performed for safe and complete laparoscopic surgery using a linear stapler after LTG. OEJ is considered to be an excellent esophageal jejunal anastomosis method because there are very few reports of anastomotic leakage and stenosis, and it can be used even when the esophageal resection length is long. However, during long-term observation of patients undergoing OEJ after LTG, patients may experience passage obstruction due to bending of the elevated jejunum near the esophageal hiatus without anastomotic stenosis. As a general rule, this complication requires re-operation to relieve the stenosis, but there have been no reports of passage obstruction in OEJ without the anastomotic stenosis. Therefore, by extracting patients who have developed this complication and analyzing the patient factors, clinicopathological factors, perioperative factors, surgical findings, in detail, the characteristics of treatment and prevention of this complication can be identified. The purpose is to clarify.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Treatment and characteristics of prevention in this complication.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	From April 2009 to May 2020, patients who underwent laparoscopic total gastrectomy for gastric cancer at Saga University Hospital in department of Surgery and underwent esophagojejunostomy using the Overlap method. Among them, patients who had an obstruction of passage in the elevated jejunum due to flexion at the anastomotic site of the esophagus and jejunum.
Key exclusion criteria	Patients who are out of regular surveillance. Patients who required intrathoracic OEJ through a thoracoscopic approach because they required excision of over 4 cm of esophagus.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Hirokazu Middle name Last name Noshiro
Organization	Faculty of medicine, Saga University
Division name	Department of Surgery
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga, 849-8501, JAPAN
TEL	0952-34-2349
Email	noshiro@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Keiichiro Middle name Last name Okuyama
Organization	Faculty of medicine, Saga University
Division name	Department of Surgery
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga, 849-8501, JAPAN
TEL	0952-34-2349
Homepage URL
Email	f8391@cc.saga-u.ac.jp

Sponsor
Institute	Saga University
Institute
Department

Funding Source
Organization	Saga University
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	Saga University Hospital
Address	5-1-1 Nabeshima, Saga, 849-8501, JAPAN
Tel	0952-34-6511
Email	kenkyu-shinsei@ml.cc.saga-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	2021 Year 05 Month 10 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	211
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	No longer recruiting
Date of protocol fixation	2009 Year 04 Month 01 Day
Date of IRB	2020 Year 07 Month 06 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date	2025 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

From April 2009 to May 2020, in department of Surgery at Saga University Hospital, targeting gastric cancer who underwent LTG and OEJ, reoperation was required due to passage obstruction due to flexion at the esophageal jejunum anastomosis. We will extract the patients who have undergone surgery, analyze their patient factors, clinicopathological factors, perioperative factors, surgical findings, etc., and clarify the characteristics of treatment and prevention of this complication.

Management information
Registered date	2021 Year 05 Month 10 Day
Last modified on	2021 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050428