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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030733
Receipt No. R000030467
Scientific Title Functional evaluation of the gastric conduits after esophagectomy using High Resolution Manometry (HRM) and 24hr-pH monitoring examination
Date of disclosure of the study information 2018/01/09
Last modified on 2018/01/09

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Basic information
Public title Functional evaluation of the gastric conduits after esophagectomy using High Resolution Manometry (HRM) and 24hr-pH monitoring examination
Acronym Functional evaluation of the gastric conduits after esophagectomy using HRM and 24hr-pH monitoring examination
Scientific Title Functional evaluation of the gastric conduits after esophagectomy using High Resolution Manometry (HRM) and 24hr-pH monitoring examination
Scientific Title:Acronym Functional evaluation of the gastric conduits after esophagectomy using HRM and 24hr-pH monitoring examination
Region
Japan

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

Objectives
Narrative objectives1 Esophagectomy for esophageal cancer has a variety of surgical strategies in reconstructions using gastric conduits, which may affect the patients' postoperative daily-life activities. The aim of this study is to evaluate the differences of the physiological environment inside gastric conduits in each reconstruction strategy in terms of peristaltic intensity and digestive juice reflux, using a High Resolution Manometry (HRM) device and a 24-hour pH monitoring device.
Basic objectives2 Others
Basic objectives -Others Physiological evaluation
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Differences in peristaltic intensity among gastric conduit reconstruction strategies in the fasting state.
2) Differences in DeMeester scores/Time percentage below pH4 at the (remnant) esophagus levels among gastric conduit reconstruction strategies.
Key secondary outcomes 1) Changes in peristaltic intensity and frequency of peristalsis of the gastric conduit in each patient.
2) Correlation between the refluxive inflammation levels and the peristaltic intensity levels (include gross evaluations with endoscopic examinations).
3) Correlation between the refluxive inflammation levels and the DeMeester scores/Time percentage below pH4 at the (remnant) esophagus levels.
4) Correlation between the peristaltic intensity levels (include gross evaluations with endoscopic examinations) and the DeMeester scores/Time percentage below pH4 at the (remnant) esophagus levels.
5) Correlation between the nutritional markers (Onodera's prognostic nutritional index, serum PreAlb level, change in body weight)and the peristaltic intensity levels (include gross evaluations with endoscopic examinations).
6) Correlation between the nutritional markers (Onodera's prognostic nutritional index, serum PreAlb level, change in body weight)and the DeMeester scores/Time percentage below pH4 at the (remnant) esophagus levels.
7) Comparision between the postoperative patients and the preoperative patients in terms of periastaltic intensity levels and DeMeester scores/Time percentage below pH4 at the (remnant) esophagus levels.
8) Correlation between the lapsed months after the surgeries and the periastaltic intensity levels.
9) Correlation between the lapsed months after the surgery and the DeMeester scores/Time percentage below pH4 at the (remnant) esophagus levels.
10) Correlation between the QOL questionnaire results and the refluxive inflammation levels.
11) Completion rates of the examinations.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 1)Blood sampling at the outpatient ward before the examinations below (~5 munites).
2) Endoscopic examination of the gastric conduit under video fluoroscopy and the placement of a marking clip on the oral side near the Pylorus (~10 minutes).
3)Intranasal placement of the High Resolution Manometry (HRM) catheter through the gastric conduit and the recording of the manometric data during a fasting state (90 minutes).
4) Recording of the manometric data of the gastric conduit whlie swallowing diluted contrast under video fluoroscopy (~10 minutes).
5) Recording of the manometric data of the gastric conduit during the fed state after liquid meal intake (90 munites).
6) Removing the HRM catheter and intranasal placement of the 24-hour pH monitoring catheter for 24-hour pH recording (24 hours).
7) Removing the 24-hour pH catheter (5 minutes).
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria [Criteria for postoperative patitents]
1) Those who underwent esophagectomy with a gastric conduit reconstruction at The University of Tokyo Hospital.
2) 20 years of age or over and not more than 85 years old.
3) Not recieving current adjuvant therapies.
4) No current indications or past histories of recurrence.
5) No current malignancies in other organs.
6) Not hospitalized for treatments.
7) Whose H.Pylori infection status can be confirmed by endoscopic biopsy or blood test before the manometric measurement or 24-hour pH monitoring test.
8) Agreed to participate in the study in documents.

[Criteria for preoperative patitents]
1) superficial esophageal cancer patients (cT1a/bN0M0) without any previous or current systemic neoadjuvant therapies.
2) 20 years of age or over and not more than 85 years old.
3) No previous or current systemic therapy
4) No current malgnancies in other organs.
5) Not hospitalized for treatments.
6) Whose H.Pylori infection status can be onfirmed by endoscopic biopsy or blood test before the manometric measurement or 24-hour pH monitoring test.
7) Agreed to participate in the study in documents.
Key exclusion criteria 1) Spent less than 1 year after the surgery (except for preoperative patients).
2) Have contraindications to Esophagogastroduodenoscopy.
3) Have contraindications to High Resolution Manometry examination, which are determined by the device distributor.
4) Have difficulties in completing 24-hour pH monitoring.
5) Have severe hoarseness and/or dysphagia and difficult to swallow with the catherters intranasally inserted.
6) Impossible to suspend drug intakes: enterokinetic agents, antiacid agents, cholinergic or anti-cholinergic agents for other diseases than esophageal cancer.
7) Proved to have residual food inside gastric conduit during esophagogastroduodenoscopy.
8) Have allergies with the drugs used in the study examination.
9) Pregnant.
10) Already participated in the study within 1 year.
11) Have other ineligible factors judged by the researchers of the study.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyuki Seto
Organization Graduate School of Medicine, University of Tokyo
Division name Gastrointestinal Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-3815-5411
Email seto-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuichiro Oya
Organization Graduate School of Medicine, University of Tokyo
Division name Gastrointestinal Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-3815-5411
Homepage URL
Email OYAS-SUR@h.u-tokyo.ac.jp

Sponsor
Institute University of Tokyo
Institute
Department

Funding Source
Organization Department of Gastrointestinal Surgery, Graduate School of Medicine, University of Tokyo
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
Address
Tel
Email

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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 09 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
2017 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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 01 Month 09 Day
Last modified on
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030467

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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