NCT07790809Toboroz

Safety and Short-term Outcomes of Modular Robotic System for Siewert II/III Gastroesophageal Junction Cancer

A Prospective Single-arm Study Evaluating the Safety and Short-term Outcomes of Modular Robotic System for Siewert II/III Gastroesophageal Junction Cancer

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 2.

Rövid összefoglaló (regiszter, angolul)

Siewert type II/III gastroesophageal junction (GEJ) adenocarcinoma is a challenging malignancy located at the anatomical transition between the esophagus and stomach. Due to its complex anatomical location and mixed biological characteristics of esophageal and gastric cancers, the optimal surgical strategy remains controversial. Current surgical approaches vary in terms of operative access, extent of resection, and lymph node dissection. Although minimally invasive laparoscopic and integrated robotic surgery have demonstrated potential advantages in improving perioperative outcomes, limitations remain when managing complex procedures involving both abdominal and mediastinal fields. Split-type robotic surgical systems, characterized by independently movable robotic carts, provide greater flexibility in robotic arm positioning and may overcome some limitations associated with conventional integrated robotic platforms, particularly in extensive multi-quadrant procedures requiring simultaneous abdominal and mediastinal lymph node dissection. However, clinical evidence regarding the safety and effectiveness of split-type robotic surgery for Siewert type II/III GEJ cancer remains limited. This prospective single-arm clinical study aims to evaluate the feasibility, safety, and short-term surgical outcomes of split-type robotic radical surgery for patients with Siewert type II/III GEJ adenocarcinoma. The study will assess perioperative outcomes, including operative characteristics, postoperative complications, lymph node dissection quality, and short-term recovery parameters. The findings of this study are expected to provide preliminary clinical evidence regarding the application of split-type robotic technology in complex GEJ cancer surgery and support future large-scale clinical investigations.

Állapot (regiszter): Toboroz
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 25 (tervezett)
Első benyújtás: 2026. aug. 20.
Kezdés: 2026. aug. 20.
Elsődleges befejezés: 2027. febr. 20.
Fő szponzor: The First Hospital of Jilin University
Betegségek: Gyomor- és nyelőcsőrák
NCT-szám: NCT07790809

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó
Tervezett résztvevők: 25
2026. aug. 20. és az elsődleges befejezés (2027. febr. 20.) között
1 helyszín, 1 országban
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Korábbi kezelés

Patients with metastatic lymph nodes fused together or encasing major blood vessels, making curative resection infeasible.
Patients with previous abdominal/pelvic surgery, radiotherapy, or chemotherapy that may affect the feasibility of laparoscopic or robotic surgery.
Patients currently participating in other clinical trials involving investigational drugs or medical devices.

Más betegség

Patients with severe cardiac, pulmonary, neurological, hepatic, or renal diseases that may prevent tolerance of surgery or anesthesia.
Patients unable to tolerate pneumoperitoneum or considered by the investigator to have extensive intra-abdominal adhesions or other conditions preventing safe establishment of pneumoperitoneum.
Patients with severe coagulation disorders that contraindicate minimally invasive surgery.
Patients with active pulmonary tuberculosis.
Patients with severe uncontrolled diseases, acute infections, severe physical deterioration, massive ascites, active intra-abdominal bleeding, or shock.

Egyéb

Patients with body mass index (BMI) \<18.5 kg/m² or BMI ≥35 kg/m².
Pregnant or breastfeeding women.
Patients considered unsuitable for this study by the investigator.

Kiket keres a vizsgálat

Age between 18 and 80 years, inclusive, regardless of sex.
Histologically and/or cytologically confirmed Siewert type II or type III gastroesophageal junction tumor, with clinical staging according to AJCC 8th edition TNM classification indicating suitability for curative surgical resection.
Adequate organ function as assessed by the investigator before surgery.
Provision of written informed consent and willingness to participate in the study.
Ability and willingness to comply with study procedures and follow-up requirements.
ECOG performance status of 0-1.
Absence of distant metastasis confirmed by preoperative thoracoabdominal and pelvic CT or PET-CT.

Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
First Hospital of Jilin Universiry Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát	Changchun	Kína	Toboroz

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