[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05205343":3,"trial-entities:NCT05205343":123,"trial-summary:NCT05205343":128},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":23,"healthy_volunteers":14,"eligibility_criteria":45,"std_ages":49,"locations":52,"central_contacts":107,"overall_officials":110,"references":112,"see_also_links":120},"NCT05205343","2021-0914","Trans-Pacific Multicenter Collaborative Study of Minimally Invasive Proximal Versus Total Gastrectomy for Proximal Gastric and Gastroesophageal Junction Cancers","RECRUITING","2028-05-31","2026-08","2026-08-21","2022-05-11","M.D. Anderson Cancer Center","OTHER",false,"To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.","Primary Objective:\n\nDelineate the short-term appetite of patients who undergo minimally-invasive proximal gastrectomy (MIPG) and compare them with those of patients with gastric and gastroesophageal adenocarcinoma who undergo total gastrectomy (MITG). We hypothesize that MIPG is associated with better postoperative appetite levels compared to MITG, which would result in improved nutritional status and maintained body weight after surgery.\n\nSecondary Objective:\n\n\\- Assess patient-reported outcomes (PROs) and nutrition measures. We will use the MD Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI-GI) questionnaire with additional three experimental question items (\"PRO questionnaire\") to collect preoperative and postoperative patient-reported outcomes (PROs) of QoL and check fasting ghrelin levels to correlate them with reported appetite levels. We will also retrospectively investigate factors associated with improved QoL after surgery, safety of MIPG and MITG, and oncological outcomes after MIPG and MITG.",[18,19,20],"Gastrostomy","Gastric","GastroEsophageal Cancer",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},20,"ESTIMATED",[29,33],{"type":13,"name":30,"description":31,"armGroupLabels":32},"Standard of Care","complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery",[30],{"type":13,"name":34,"description":31,"armGroupLabels":35},"Control Group",[36],"Control group",[38],{"measure":39,"description":40,"timeFrame":41},"(MDASI-GI) MD Anderson Symptom Inventory Questionnaire","Appetite level (reported on a 0-10 scale, in Q8 of MDASI-GI) scale 0-not present-10 as bad as you can image","3 months after surgery",[],"ALL","18 Years",{"inclusion":46,"exclusion":47,"raw_text":48},[],[],"Inclusion:\n\n1. Able to speak and read English, Spanish, Japanese or Korean\n2. Participants with a biopsy-confirmed diagnosis of non-metastatic gastric or GEJ adenocarcinoma, who are scheduled to undergo MIPG or MITG for curative-intention\n3. Age ≥ 18\n\nExclusion:\n\n1. Participants with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract\n2. Participants with known narcotic dependence, with average daily dose \\> 5 mg oral morphine equivalent\n3. Participants deemed unable to comply with study and\u002For follow-up procedures, at investigators' discretion\n4. Participants who are pregnant (since are excluded from receiving standard-of-care MIPG or MITG)",[50,51],"ADULT","OLDER_ADULT",[53,63,79,93],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"geoPoint":60},"Mayo Clinic in Rochester","ACTIVE_NOT_RECRUITING","Rochester","Minnesota","55905","United States",{"lat":61,"lon":62},44.02163,-92.4699,{"facility":64,"status":7,"city":65,"state":66,"zip":67,"country":59,"contacts":68,"geoPoint":76},"M D Anderson Cancer Center","Houston","Texas","77030",[69,74],{"name":70,"role":71,"phone":72,"email":73},"Naruhiko Ikoma, MD","CONTACT","832-729-2675","nikoma@mdanderson.org",{"name":70,"role":75},"PRINCIPAL_INVESTIGATOR",{"lat":77,"lon":78},29.76328,-95.36327,{"facility":80,"status":7,"city":81,"zip":82,"country":83,"contacts":84,"geoPoint":90},"Keio University School of Medicine","Tokyo","1600016","Japan",[85,89],{"name":86,"role":71,"phone":87,"email":88},"Satoru Matsuda, MD, PhD","+81 3-3353-1211","s.matsuda.a8@keio.jp",{"name":86,"role":75},{"lat":91,"lon":92},35.6895,139.69171,{"facility":94,"status":7,"city":95,"zip":96,"country":97,"contacts":98,"geoPoint":104},"Yonsei University College of Medicine","Soeul","03722","South Korea",[99,103],{"name":100,"role":71,"phone":101,"email":102},"Hyoung-II Kim, MD, PhD","+82-1599-1004","cairus@yuhs.ac",{"name":100,"role":75},{"lat":105,"lon":106},36.9168,126.7319,[108],{"name":70,"role":71,"phone":109,"email":73},"(832) 729-2675",[111],{"name":70,"affiliation":12,"role":75},[113,117],{"pmid":114,"type":115,"citation":116},"41023216","DERIVED","Ikoma N, Grotz T, Kawakubo H, Kim HI, Matsuda S, Okui J, Tomita K, Hirata Y, Nakao A, Williams LA, Wang XS, Wang X, Mansfield PF, Hyung WJ, Badgwell BD, Strong VE, Kitagawa Y. Transpacific multicenter collaborative study of minimally invasive proximal gastrectomy vs. minimally invasive total gastrectomy for proximal gastric and gastroesophageal junction cancers: 3-month follow-up results. Surg Endosc. 2025 Dec;39(12):8371-8384. doi: 10.1007\u002Fs00464-025-12257-4. Epub 2025 Sep 29.",{"pmid":118,"type":115,"citation":119},"37653380","Ikoma N, Grotz T, Kawakubo H, Kim HI, Matsuda S, Hirata Y, Nakao A, Williams LA, Wang XS, Mendoza T, Wang X, Badgwell BD, Mansfield PF, Hyung WJ, Strong VE, Kitagawa Y. Trans-pacific multicenter collaborative study of minimally invasive proximal versus total gastrectomy for proximal gastric and gastroesophageal junction cancers. BMC Surg. 2023 Sep 1;23(1):262. doi: 10.1186\u002Fs12893-023-02163-8.",[121],{"label":64,"url":122},"http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":124,"biomarkers":127},[125,126],"Gastric Carcinoma","Gastroesophageal Junction Adenocarcinoma",[],{"nct_id":4,"found":129,"summary":130,"prompt_version":140},true,{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is an observational study comparing two types of minimally invasive surgery for gastric and gastroesophageal junction cancers. It plans to include 20 participants.","completed","Study of Minimally Invasive Gastrectomy for Gastric and Gastroesophageal Junction Cancers","This study is looking at the symptoms experienced by patients who have surgery for gastric (stomach) or gastroesophageal junction (where the esophagus meets the stomach) cancer. Researchers want to compare symptoms between two types of minimally invasive surgery: proximal gastrectomy (MIPG) and total gastrectomy (MITG). You might be able to join if you are at least 18 years old, have been diagnosed with non-metastatic gastric or GEJ adenocarcinoma, and are scheduled for either MIPG or MITG surgery. The study aims to see if MIPG leads to better appetite after surgery compared to MITG. You would complete questionnaires before and after your surgery to share your experiences. The study is currently unclear on its recruitment status.","Participants will be followed for 12 months after surgery, with symptom questionnaires collected at various time points.",115,"You would complete a questionnaire within 30 days before your surgery and then again at 1, 3, 6, and 12 months after surgery.","Not stated in the trial record.",[],"v2"]