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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-00267 | Other Identifier | NCI-CTRP Clinical Trial Registry |
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To compare the symptoms of patients who have a MIPG to the symptoms of patients who have a MITG.
Primary Objective:
Delineate 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.
Secondary Objective:
- 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery. The questionnaire will ask about your health, appetite, and quality of life. It should take about 3-5 minutes to complete. |
| |
| Control group | questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery. The questionnaire will ask about your health, appetite, and quality of life. It should take about 3-5 minutes to complete. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Other | complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| (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 |
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Inclusion:
Exclusion:
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M D Anderson Cancer Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naruhiko Ikoma, MD | Contact | (832) 729-2675 | nikoma@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Naruhiko Ikoma, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Active, not recruiting | Rochester | Minnesota | 55905 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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/s00464-025-12257-4. Epub 2025 Sep 29. | |
| 37653380 |
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Control Group | Other | complete a questionnaire within 30 days before your surgery and then at 1, 3, 6, and 12 months after surgery |
|
| M D Anderson Cancer Center |
| Recruiting |
| Houston |
| Texas |
| 77030 |
| United States |
|
| Keio University School of Medicine | Recruiting | Tokyo | 1600016 | Japan |
|
| Yonsei University College of Medicine | Recruiting | Soeul | 03722 | South Korea |
|
| Derived |
| 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/s12893-023-02163-8. |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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