Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy (NCT00622804) | Clinical Trial Compass
WithdrawnPhase 3
Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy
Stopped: It was very difficult to enroll patients in this study.
South Korea90 participantsStarted 2007-07
Plain-language summary
The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).
Who can participate
Age range
20 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. have cancer located in middle or distal portions
. preoperative staged as cT1N0M0 or cT2N0M0 by computed tomography and gastrofiberscope (Endoscopic ultrasound, optionally)
. have The American Society of Anaesthesiologists (ASA) score of three and less
Exclusion criteria
. have simultaneously other cancer
. underwent cancer therapy (radiologic or immunologic or chemotherapeutic method) at past time
. have systemic inflammatory disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has been withdrawn and is no longer recruiting, can you tell me if there are any similar active studies comparing surgical approaches for managing bile reflux and gastric stasis after distal gastrectomy that I might be eligible for?
2I understand this study was specifically looking at bile reflux after distal gastrectomy — how significant a problem is bile reflux for me personally after this type of surgery, and how would it be monitored or managed as part of my standard care?
3Since this was a Phase 3 trial, it was likely comparing treatments that are already somewhat established — can you walk me through what the current standard surgical options are for reconstruction after distal gastrectomy, and how they differ in terms of bile reflux risk?
4The trial planned to measure bile reflux using something called dual scintigraphy — is that type of imaging test something that would be useful for evaluating my own situation after surgery, and would it be available to me outside of a trial?
5Given that this study was withdrawn before completing, are there published results or other completed trials you could point me to that compare reconstruction techniques after distal gastrectomy for stomach cancer, so we can make the most informed decision about my surgical plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.