Double tract reconstruction versus esophago-gastrostomy after laparoscopic proximal gastrectomy : A randomized Phase III trial to evaluate postoperative body weight change (DREAM trial)

Double tract reconstruction versus esophago-gastrostomy after laparoscopic proximal gastrectomy : A randomized Phase III trial to evaluate postoperative body weight change - Double tract reconstruction vs. esophago-gastrostomy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042183

Enrollment

120

Registered

2020-11-01

Start date

2020-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer esophagogastric junction cancer

Interventions

A: Esophago-gastrostomy B: double tract reconstruction

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven gastric carcinoma or esophagogasric junction carcinoma 2) Resectable cancer 3) Not applicable of ESD according to the Japanese classification 4) Excluding esophageal invasion > 3 cm 5) Aged 20 to 90 year 6) PS (ECOG) 0 or 1 7) BMI < 35 8) No history of gastrointestinal surgery 9) No history of chemotherapy or radiotherapy 10) Normal function of the major organs; indicated by a leukocyte count of over 3000 mm3, a platelet count of over 100 000 mm3, aspartate aminotransferase and alanine aminotransferase levels less than 200 IU/L, total bilirubin less than 3 g/dl and creatinine levels less than 2 mg/dl 11) Proven written informed consent 12) Both reconstructions can be safely performed by intraoperative judgment

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous malignancies other than carcinoma in situ 2) Pregnancy or breast-feeding 3) Severe mental disease 4) Continuous systemic steroid therapy 5) History of myocardial infarction or unstable angina pectoris within six months 6) Doctors decision not to register to this trial

Design outcomes

Primary

Measure	Time frame
Incidence rate of over 20% weight loss in one year after surgery	—

Secondary

Measure	Time frame
Incidence rate of average weight loss in one and three year after surgery, Incidence of over 20% weight loss in three year after surgery, Incidence of reflux esophagitis, and anastomotic stricture, anastomotic leakage and all postoperative complications, duration of surgery, blood loss, blood transfusion, Hemoglobin, Total protein, Albumin, QOL evaluation, recurrence free survival, overall survival	—

Measure

Time frame

Incidence rate of average weight loss in one and three year after surgery, Incidence of over 20% weight loss in three year after surgery, Incidence of reflux esophagitis, and anastomotic stricture, anastomotic leakage and all postoperative complications, duration of surgery, blood loss, blood transfusion, Hemoglobin, Total protein, Albumin, QOL evaluation, recurrence free survival, overall survival

—

Countries

Japan

Contacts

Public ContactKeiji Hayata

Wakayama Medical University Second Department of Surgery

keiji@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026