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Totally robotic proximal gastrectomy with Kamikawa reconstruction for adenocarcinoma of the upper stomach and esophagogastric junction: an ideal stage 2a study (The RPG-DFT study)

Totally robotic proximal gastrectomy with Kamikawa reconstruction for adenocarcinoma of the upper stomach and esophagogastric junction: an ideal stage 2a study (The RPG-DFT study)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090576
Enrollment
Unknown
Registered
2024-10-09
Start date
2024-10-10
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

Esophageal-gastric junction adenocarcinoma and upper gastric cancer

Interventions

cT1~4aN0~1M0, Siewert III type esophageal-gastric junction adenocarcinoma and upper gastric cancer in stage I~II:None

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) After preoperative gastroscopy biohistopathological examination and imaging examination, it was confirmed that it was Siewert III type esophaga-gastric junction adenocarcinoma or upper gastric adenocarcinoma without metastasis. The tumor diameter is <4 cm, and the length of esophageal invasion is =2 cm; the preoperative clinical stage is cT1~4aN0~1M0, Phase I~II (according to the AJCC 8th TNM installment standard); (2) No history of other malignant tumors in the past; (3) The patient's informed consent form has been signed; (4) Male or female patients aged 18~80; (5) Cardiopulmonary, liver and kidney function is basically normal, ECOG physical condition score 0~1 points, preoperative ASA score I~III points (see the appendix for details of ECOG and ASA scoring criteria); (6) Clinicians judge that the patient does not need emergency surgery; there has been no new auxiliary chemotherapy, radiotherapy or immunotherapy in the past.

Exclusion criteria

Exclusion criteria: (1) Consider cTanyN2~3M0 in the clinical stage of the tumor; (2) The tumor size is >4cm or the tumor site is located in the middle or lower part of the stomach body, such as parts that are not suitable for proximal gastrectomy; (3) Multiple malignant foci in the stomach or esophagus, such as a history of malignant tumors in the stomach or esophagus, including stromal tumors, sarcoma, lymphoma and carcinoid; (4) When diagnosed, it is accompanied by distant metastasis of the liver, lungs, bones, peritoneum, distant lymph nodes, etc. or accompanied by a large amount of ascites; (5) At the time of diagnosis, the risk of general anesthesia or the operation cannot be tolerated due to malignant fluid, etc.; (6) Patients with other serious diseases, including cardiovascular, respiratory, kidney, central nervous system or liver diseases, combined with poorly controlled hypertension and diabetes; (7) Those who have a history of uncontrolled epilepsy, central nervous system disease or mental disorder; (8) Patients who have participated in or are participating in other clinical trials within the first 4 weeks of being selected; (9) Patients who have undergone surgery and the effects have not been eliminated; (10) Emergency surgery is required due to tumor emergencies (bleeding, perforation, obstruction); (11) Pregnant or lactating women; (12) Patients with active infection (fever of more than 38? caused by infection); (13) Poor patient compliance or researchers consider poor patient compliance; (14) Those who have a history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical cancer in situ;

Design outcomes

Primary

MeasureTime frame
Surgical safety indicators;

Secondary

MeasureTime frame
Relevant indicators of surgical quality evaluation;Postoperative recovery indicators;Pathological result indicators;Indicators of the quality of life after surgery;Nutritional indicators and learning curve evaluation;

Countries

China

Contacts

Public ContactYuan Shuqiang

Sun Yat-sen University Cancer Center

yuanshq@sysucc.org.cn+86 135 1271 3583

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026