Esophageal Cancer
Conditions
Interventions
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
Sponsors
University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactShuichiro Oya
Graduate School of Medicine, University of Tokyo Gastrointestinal Surgery
Outcome results
None listed