UMIN-CTR Clinical Trial

Basic information
Public title	A randomized phase II study of hand-assisted laparoscopic versus laparoscopic-assisted gastric mobilization for patients with curative surgery for thoracic esophageal cancer
Acronym	A randomized study of laparoscopic gastric mobilization for thoracic esophageal cancer
Scientific Title	A randomized phase II study of hand-assisted laparoscopic versus laparoscopic-assisted gastric mobilization for patients with curative surgery for thoracic esophageal cancer
Scientific Title:Acronym	A randomized study of laparoscopic gastric mobilization for thoracic esophageal cancer
Region	Japan

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

Objectives
Narrative objectives1	To examine the safety of laparoscopic-assisted gastric mobilization compared with hand-assisted laparoscopic surgery after curative esophagectomy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reconstructed gastric tube-related complication using Clavien-Dindo grading system
Key secondary outcomes	1) All complication using Clavien-Dindo grading system, 2) Operative time, 3) Estimated blood loss, 4) Conversion of operative procedure, 5) Adverse event of surgery, 6) QOL score, 7) Number of dissected abdominal lymph nodes, 8) Overall survival time.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Hand-assisted laparoscopic gastric mobilization for patients with curative surgery for thoracic esophageal cancer
Interventions/Control_2	Laparoscopic-assisted gastric mobilization for patients with curative surgery for thoracic esophageal cancer
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Primary lesions are all confined within the thoracic esophagus, 2) an esophageal epithelial malignancy, 3) cT1-3, cN0-3 (exclude celiac lymph nodes) and cM0, 4) Surgery approached from the neck, chest and abdomen, 5) R0 resection with radical dissection, 6) Reconstruction by gastric tube, 7) >20 and <80 y.o., 8) ECOG-PS 0 or 1, 9) No history of surgery for esophageal cancer, 10) No history of chemotherapy or radiotherapy, 11) No history of surgery to upper abdomen, 12) a) WBC >2000 and <10000/mm3, b) PLT >50000/mm3, c) Hb >10.0 g/dl, d) AST <100 IU/L, ALT <100IU/L, e) T-Bil <2.0 g/dl, f) Cre <1.5mg/dl, 13) Written consent
Key exclusion criteria	1) BMI <17.0 or >30.0, 2) Excision of other organs excluding gall bladder or spleen (for bleeding), 3) Active double cancer, 4) Pregnancy or breast-feeding, 5) Psychosis or mental symptoms, 6) Systemic administration of steroids, 7) History of myocardial infarction or unstable angina, 8) Poorly controlled hypertension, 9) Poorly controlled diabetes, 10) Respiratory disease requiring sustained oxygen therapy.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Kamei
Organization	Tohoku University Hospital
Division name	Department of Surgery
Zip code	980-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL	022-717-7214
Email	tkamei@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Okamoto
Organization	Tohoku University Hospital
Division name	Department of Surgery
Zip code	980-8574
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL	022-717-7214
Homepage URL
Email	hi-ok@surg.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	University grants of Tohoku University Hospital
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	Independent Ethics Committee, Tohoku University Hospital
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
Tel	022-717-7146
Email	rinri-2@proj.med.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（宮城県）

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 01 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	2018 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 07 Day
Last modified on	2019 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038384