A Phase 3 interventional study of Roux-en Y reconstruction and Billroth-I reconstruction in Gastric Cancer, sponsored by Wakayama Medical University. Completed at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Wakayama Medical University · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 181 studies in Stomach Neoplasms with a site in Japan — 33 open to participants now, 55 under way, 12 of them phase 3. Stomach Neoplasms · Japan.
Among the 181 studies in Stomach Neoplasms with a site in Japan, this one is the 92nd largest by enrollment of the 162 interventional ones that give a count, is one of 6 that started in 2009, is one of 54 in phase 3, and was the 48th registered.
3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.
Browse Stomach Neoplasms studies →33 of the 181 studies in Stomach Neoplasms with a site in Japan are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Japan, Australia
Ages 18+
National Cancer Center, Japan · Sites in Japan
Ages 18+
Kansai Medical University · Sites in Japan
Ages 18+
Pfizer · Sites in Japan, United States, Canada and 7 more countries
Ages 18+
Bristol-Myers Squibb · Sites in Japan, United States, Argentina and 17 more countries
Ages 18+
A study can be open while its sites in Japan have not opened yet or have stopped. Only those recruiting at a site in Japan →
Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.
This study: 20 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
181 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 56 · Phase 2 70 · Phase 3 61
First in 1993; this study’s year is marked. 6 started in 2009.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 120 is above the median of 66 across 2,500 interventional studies indexed under Stomach Neoplasms.
Median enrollment 158 across the 162 interventional studies, 369 across the 17 observational. Of the 111 that completed or were terminated, 37 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
121 of 181 have an industry lead sponsor. The 10 most frequent:
Wakayama Medical University is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
Wakayama Medical University has 3 studies filed under Stomach Neoplasms — fewer than ten, so there is no comparison to draw.
15 of the studies in Stomach Neoplasms with a site in Japan that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06532006Phase 3Shanghai Henlius BiotechA Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer | 2027-06-01 |
| NCT06219941AstraZenecaAZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 | 2026-11-17 |
| NCT05094336AmgenA Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) | 2026-11-30 |
| NCT06921928AstraZenecaStudy for AZD4360 in Participants With Advanced Solid Tumours | 2027-03-31 |
| NCT04379596AstraZenecaPh1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) | 2027-05-04 |
Add all 15 to your calendar (.ics) → With an account.
Among the 181 studies in Stomach Neoplasms with a site in Japan, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer.
The purpose of this study is to evaluate the quality of life (QOL) after Billroth-I reconstruction (B-I) following distal gastrectomy, compared with Roux-en Y reconstruction (R-Y) in patients with gastric cancer. There is no prospective randomized study of the two operative procedures focusing on postoperative QOL. The investigators conducted a prospective randomized trial on 120 patients who underwent distal gastrectomy comparing Billroth-I reconstruction and Roux-en Y reconstruction.
The primary endpoint was the postoperative QOL. The secondary endpoints were the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis. Patients were recruited into this study before surgery, on the basis of whether distal gastrectomy was anticipated at Wakayama Medical University Hospital(WMUH) for gastric cancer, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients with history of other organ malignancies, 3) patients who were diagnosed inadequacy for this study by a physician, and 4) patients without an informed consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Roux-en Y reconstruction after distal gastrectomy
Procedure: Roux-en Y reconstruction
Billroth-I reconstruction after distal gastrectomy
Procedure: Billroth-I reconstruction
surgical procedure
surgical procedure
the postoperative quality of life (QOL)
Time frame: 3 years after operation
the incidence of postoperative complications, nutritional status, and the incidence of the remnant gastritis and the reflux esophagitis
Time frame: 1, 3 and 5 years after operation
The record gives a start of Jan 2009, a primary completion of Sep 2013 and a completion of Nov 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wakayama Medical University