UMIN-CTR Clinical Trial

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

Esophageal Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name	Yasuyuki
Middle name
Last name	Seto

Organization

Graduate School of Medicine, University of Tokyo

Division name

Gastrointestinal Surgery

Zip code

1138655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan

TEL

03-3815-5411

Email

seto-tky@umin.ac.jp

Name of contact person

1st name	Shuichiro
Middle name
Last name	Oya

Organization

Graduate School of Medicine, University of Tokyo

Division name

Gastrointestinal Surgery

Zip code

113-8655

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

Institute

University of Tokyo

Institute

Department

Personal name

Organization

Department of Gastrointestinal Surgery, Graduate School of Medicine, University of Tokyo

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical comittee of the University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan

Tel

03-5841-3557

Email

ethics@m.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京大学医学部附属病院(東京都)

Date of disclosure of the study information

2018

Year

01

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2017

Year

05

Month

02

Day

Date of IRB

2017

Year

07

Month

11

Day

Anticipated trial start date

2017

Year

07

Month

12

Day

Last follow-up date

2021

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

01

Month

09

Day

Last modified on

2019

Year

09

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030467