Siewert Type II/III Gastroesophageal Junction AdenocarcinomaROBOT-GEJNCT07790809
Safety and Short-term Outcomes of Modular Robotic System for Siewert II/III Gastroesophageal Junction Cancer
A study testing Robotic-assisted radical resection for Siewert type II/III gastroesophageal junction cancer in people with Siewert Type II/III Gastroesophageal Junction Adenocarcinoma, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Siewert Type II/III Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Robotic-assisted radical resection for Siewert type II/III gastroesophageal junction cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with body mass index (BMI) <18.5 kg/m² or BMI ≥35 kg/m².
- 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.
Show all 11Show fewer
- 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.
- Pregnant or breastfeeding women.
- Patients currently participating in other clinical trials involving investigational drugs or medical devices.
- Patients considered unsuitable for this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin Universiry
Changchun, Jilin, 130021
Quan Wang, +86 15843073207, wquan@jlu.edu.cn
About this study
Official title: A Prospective Single-arm Study Evaluating the Safety and Short-term Outcomes of Modular Robotic System for Siewert II/III Gastroesophageal Junction Cancer
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.
Read the detailed description
Siewert type II/III gastroesophageal junction (GEJ) adenocarcinoma represents a unique clinical entity located at the junction between the distal esophagus and proximal stomach. According to the Siewert classification, type II tumors are defined as tumors with their epicenter located from 1 cm above to 2 cm below the esophagogastric junction, whereas type III tumors extend from 2 cm to 5 cm below the junction. Due to their distinct anatomical characteristics and lymphatic drainage patterns, these tumors present unique challenges in surgical management.
Siewert type II tumors have a relatively increased risk of mediastinal lymph node metastasis, while Siewert type III tumors primarily involve abdominal lymphatic pathways. Consequently, significant controversy remains regarding the optimal surgical approach, including the choice between transthoracic and transabdominal approaches, esophagectomy versus gastrectomy, and the appropriate extent of lymphadenectomy. In particular, the management of Siewert type II tumors remains debated because of their overlapping features between esophageal and gastric cancers. Currently, Siewert type III tumors are generally treated according to gastric cancer principles, with total gastrectomy and D2 lymphadenectomy being widely accepted surgical strategies.
Minimally invasive surgery has increasingly been applied in GEJ cancer treatment. Previous studies have demonstrated that laparoscopic surgery may provide advantages in reducing surgical trauma and improving short-term postoperative recovery compared with open surgery. However, existing evidence is primarily derived from retrospective studies, with considerable heterogeneity and limited long-term oncological outcome data.
Robotic-assisted surgery has emerged as an advanced minimally invasive approach, offering three-dimensional visualization, enhanced instrument dexterity, motion scaling, and improved ergonomics. Small retrospective series using the da Vinci integrated robotic platform for Siewert type II/III GEJ cancer surgery have demonstrated acceptable perioperative safety and feasibility. However, conventional integrated robotic systems have limitations in complex procedures requiring extensive operative fields. Due to restricted robotic arm mobility and fixed configuration, procedures involving both thoracic and abdominal regions may require intraoperative redocking, which may interrupt surgical workflow, prolong operative time, and reduce procedural efficiency.
The split-type robotic surgical system provides an alternative robotic platform design consisting of multiple independently movable robotic carts. This configuration allows more flexible arrangement of robotic arms according to surgical requirements and may be particularly advantageous for Siewert type II/III GEJ cancer surgery, where both mediastinal and abdominal lymph node dissection may be required. Compared with integrated robotic systems, split-type robotic platforms may reduce the need for intraoperative redocking, maintain procedural continuity, decrease mechanical interference, and improve surgical efficiency during complex multi-quadrant operations.
The Carina™ Split-type Surgical Robotic System and compatible surgical instruments developed by Ruilong Nuofu (Shanghai) Medical Technology Co., Ltd. have obtained approval from the National Medical Products Administration (NMPA) of China. The system has fulfilled regulatory requirements for investigator-initiated clinical studies according to relevant medical device regulations and clinical trial quality management principles. Previous clinical applications of the Carina™ system in multiple surgical specialties, including gastrointestinal surgery, have demonstrated acceptable safety profiles and perioperative outcomes.
Nevertheless, despite these theoretical advantages, clinical evidence regarding the application of split-type robotic systems in radical surgery for Siewert type II/III GEJ cancer remains lacking. In particular, whether split-type robotic surgery can improve operative efficiency, facilitate lymph node dissection, reduce surgical interruptions, and maintain acceptable perioperative safety has not been prospectively evaluated.
Therefore, this prospective single-arm clinical study is designed to investigate the feasibility, safety, and short-term outcomes of split-type robotic radical surgery for patients with Siewert type II/III GEJ adenocarcinoma. The study will evaluate perioperative parameters, including operative time, intraoperative blood loss, conversion rate, postoperative complications, recovery indicators, pathological outcomes, and lymph node dissection results.
The results of this study will provide preliminary clinical evidence regarding the role of split-type robotic technology in complex GEJ cancer surgery. These findings may serve as a foundation for future multicenter clinical trials, optimization of robotic surgical strategies, establishment of standardized surgical protocols, and improvement of clinical outcomes for patients with Siewert type II/III GEJ adenocarcinoma.
- Being tested
- Robotic-assisted radical resection for Siewert type II/III gastroesophageal junction cancer
- Keywords
- Gastroesophageal Junction Adenocarcinoma, Siewert Type II/III, Modular Robotic Surgery, Minimally Invasive Surgery, Lymph Node Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted radical resection for Siewert type II/III gastroesophageal junction cancerProcedure or surgery
Patients will undergo totally robotic-assisted radical surgery for Siewert type II/III gastroesophageal junction cancer. The surgical procedure includes robotic-assisted tumor resection and lymph node dissection according to standard oncologic principles.
| Study group | Role | What they receive |
|---|---|---|
| Carina Robotic Surgery Group | Experimental | Patients with Siewert type II/III gastroesophageal junction adenocarcinoma who undergo radical surgical resection assisted by the Carina modular surgical robotic system. All participants will receive the same robotic surgical intervention, and perioperative safety, surgical outcomes, pathological outcomes, and short-term postoperative recovery will be evaluated prospectively. Receives: Procedure: Robotic-assisted radical resection for Siewert type II/III gastroesophageal junction cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful Completion of Robotic Surgery Without Conversion
The proportion of patients who successfully complete radical resection using the Carina modular robotic surgical system without conversion to conventional laparoscopy or open surgery. Conversion includes unplanned transition to another surgical approach due to technical difficulties, intraoperative complications, or inability to complete the planned robotic procedure.
Measured: Intraoperatively
Incidence of Perioperative Complications (Clavien-Dindo Classification)
The incidence and severity of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo grading system. Complications include surgical and medical adverse events occurring during the perioperative period.
Measured: Within 30 days after surgery
Secondary outcomes (25)
Achievement Rate of D2 Lymphadenectomy
The proportion of patients achieving complete D2 lymph node dissection according to the Japanese Gastric Cancer Treatment Guidelines. The adequacy of lymphadenectomy will be assessed based on intraoperative findings and postoperative pathological examination.
Measured: Perioperative/Periprocedural
Number and Metastatic Rate of Lymph Nodes in the Lower Mediastinal and Suprapancreatic Regions
The number of harvested lymph nodes and the proportion of metastatic lymph nodes in specific anatomical regions, including lower mediastinal lymph nodes and suprapancreatic lymph nodes, will be evaluated based on postoperative pathological examination.
Measured: Within 14 days after surgery (pathological assessment)
Postoperative Pathological Stage (pTNM Classification)
The pathological tumor stage will be determined according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system.
Measured: Within 14 days after surgery
R0 Resection Rate
The proportion of patients achieving complete tumor resection with microscopically negative margins (R0 resection) according to postoperative pathological examination.
Measured: Within 14 days after surgery
Proximal and Distal Resection Margin Distance
The length of proximal and distal surgical margins measured from the tumor edge to the resection margin based on pathological examination.
Measured: Within 14 days after surgery
Incidence of Specific Postoperative Complications
The incidence of specific postoperative complications within 30 days after surgery, including:
Anastomotic leakage Bleeding requiring blood transfusion Chylothorax Surgical site infection Pulmonary complications Deep venous thrombosis
Measured: Within 30 days after surgery
Estimated Intraoperative Blood Loss
Estimated Intraoperative Blood Loss
Measured: During the index operation
Device- and Instrument-related Adverse Events
The incidence of adverse events related to the Carina™ split-type robotic surgical system and associated instruments, including device malfunction, instrument failure, or unexpected technical issues.
Measured: From surgery initiation to 30 days after surgery
Type of Gastrointestinal Reconstruction
The type of gastrointestinal reconstruction performed after tumor resection will be recorded based on operative records, including the reconstruction method and type of esophagojejunostomy or other gastrointestinal reconstruction techniques.
Measured: During surgery
30-day Postoperative Mortality
The proportion of patients who die from any cause within 30 days after surgery.
Measured: Within 30 days after surgery
30-day Hospital Readmission Rate
The proportion of patients requiring unplanned hospital readmission within 30 days after surgery.
Measured: Within 30 days after surgery
ICU Admission Rate and Duration of ICU Stay
The proportion of patients admitted to the intensive care unit after surgery and the duration of ICU stay.
Measured: From surgery until hospital discharge
Postoperative Hospital Stay
The duration of hospitalization after surgery.
Measured: From postoperative day 1 until hospital discharge
System Preparation Time
Time required for preparation, setup, and initialization of the split-type robotic surgical system before surgery.
Measured: Perioperative/Periprocedural
Robotic Arm Docking Time
Time required to complete initial docking of robotic carts and robotic arms before surgical operation.
Measured: During surgery preparation
Robot-assisted Operative Time
Duration of robotic-assisted surgical operation from initiation of robotic manipulation to completion of robotic procedures.
Measured: During surgery
Total Operative Time
Total duration from skin incision to completion of surgical closure.
Measured: During surgery
Redocking Events and Duration
Number of intraoperative robotic redocking events and cumulative duration required for robotic repositioning.
Measured: Perioperative/Periprocedural
Surgical Interruption Events and Duration
Number and duration of unplanned surgical interruptions caused by robotic system setup, instrument issues, robotic arm collision, or other technical factors.
Measured: Perioperative/Periprocedural
Time to First Ambulation
Time interval from completion of surgery to first postoperative mobilization.
Measured: From completion of surgery until first postoperative ambulation
Time to First Postoperative Flatus
Time interval from surgery completion to first passage of gas.
Measured: From completion of surgery until first postoperative flatus
Time to Initiation of Liquid Diet
Time interval from surgery completion to initiation of oral liquid intake.
Measured: From completion of surgery until initiation of oral liquid intake
Postoperative Pain Score
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm continuous scale ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at predefined postoperative time points to evaluate postoperative pain recovery.
Measured: Postoperative days 1-7
Surgeon Physical Workload Assessed by the Local Experienced Discomfort Scale
The intraoperative physical workload of the primary surgeon will be assessed using the Local Experienced Discomfort (LED) scale. Physical discomfort is rated from 0 to 10 for each assessed body region, where 0 indicates no discomfort and 10 indicates extreme discomfort. Higher scores indicate greater physical discomfort and a higher physical workload.
Measured: Immediately after surgery
Surgeon Mental Workload Assessed by the Subjective Mental Effort Questionnaire
The intraoperative mental workload of the primary surgeon will be assessed using the Subjective Mental Effort Questionnaire (SMEQ). The SMEQ ranges from 0 to 150 points, with higher scores indicating greater subjective mental effort and a higher mental workload.
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Siewert Type II/III Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790809
- Sponsor's protocol ID
- Carina-GEJ-1
- Acronym
- ROBOT-GEJ
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study involves a relatively small patient population, and participant privacy and confidentiality considerations limit the sharing of individual-level data. Data may be available from the corresponding investigator upon reasonable request and subject to institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-arm Study Evaluating the Safety and Short-term Outcomes of Modular Robotic System for Siewert II/III Gastroesophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT07790809
- Acronym / sponsor ID
- ROBOT-GEJ / Carina-GEJ-1
- Keywords
- Gastroesophageal Junction Adenocarcinoma, Siewert Type II/III, Modular Robotic Surgery, Minimally Invasive Surgery, Lymph Node Dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Siewert type II/III gastroesophageal junction (GEJ) adenocarcinoma represents a unique clinical entity located at the junction between the distal esophagus and proximal stomach. According to the Siewert classification, type II tumors are defined as tumors with their epicenter located from 1 cm above to 2 cm below the esophagogastric junction, whereas type III tumors extend from 2 cm to 5 cm below the junction. Due to their distinct anatomical characteristics and lymphatic drainage patterns, these tumors present unique challenges in surgical management.
Siewert type II tumors have a relatively increased risk of mediastinal lymph node metastasis, while Siewert type III tumors primarily involve abdominal lymphatic pathways. Consequently, significant controversy remains regarding the optimal surgical approach, including the choice between transthoracic and transabdominal approaches, esophagectomy versus gastrectomy, and the appropriate extent of lymphadenectomy. In particular, the management of Siewert type II tumors remains debated because of their overlapping features between esophageal and gastric cancers. Currently, Siewert type III tumors are generally treated according to gastric cancer principles, with total gastrectomy and D2 lymphadenectomy being widely accepted surgical strategies.
Minimally invasive surgery has increasingly been applied in GEJ cancer treatment. Previous studies have demonstrated that laparoscopic surgery may provide advantages in reducing surgical trauma and improving short-term postoperative recovery compared with open surgery. However, existing evidence is primarily derived from retrospective studies, with considerable heterogeneity and limited long-term oncological outcome data.
Robotic-assisted surgery has emerged as an advanced minimally invasive approach, offering three-dimensional visualization, enhanced instrument dexterity, motion scaling, and improved ergonomics. Small retrospective series using the da Vinci integrated robotic platform for Siewert type II/III GEJ cancer surgery have demonstrated acceptable perioperative safety and feasibility. However, conventional integrated robotic systems have limitations in complex procedures requiring extensive operative fields. Due to restricted robotic arm mobility and fixed configuration, procedures involving both thoracic and abdominal regions may require intraoperative redocking, which may interrupt surgical workflow, prolong operative time, and reduce procedural efficiency.
The split-type robotic surgical system provides an alternative robotic platform design consisting of multiple independently movable robotic carts. This configuration allows more flexible arrangement of robotic arms according to surgical requirements and may be particularly advantageous for Siewert type II/III GEJ cancer surgery, where both mediastinal and abdominal lymph node dissection may be required. Compared with integrated robotic systems, split-type robotic platforms may reduce the need for intraoperative redocking, maintain procedural continuity, decrease mechanical interference, and improve surgical efficiency during complex multi-quadrant operations.
The Carina™ Split-type Surgical Robotic System and compatible surgical instruments developed by Ruilong Nuofu (Shanghai) Medical Technology Co., Ltd. have obtained approval from the National Medical Products Administration (NMPA) of China. The system has fulfilled regulatory requirements for investigator-initiated clinical studies according to relevant medical device regulations and clinical trial quality management principles. Previous clinical applications of the Carina™ system in multiple surgical specialties, including gastrointestinal surgery, have demonstrated acceptable safety profiles and perioperative outcomes.
Nevertheless, despite these theoretical advantages, clinical evidence regarding the application of split-type robotic systems in radical surgery for Siewert type II/III GEJ cancer remains lacking. In particular, whether split-type robotic surgery can improve operative efficiency, facilitate lymph node dissection, reduce surgical interruptions, and maintain acceptable perioperative safety has not been prospectively evaluated.
Therefore, this prospective single-arm clinical study is designed to investigate the feasibility, safety, and short-term outcomes of split-type robotic radical surgery for patients with Siewert type II/III GEJ adenocarcinoma. The study will evaluate perioperative parameters, including operative time, intraoperative blood loss, conversion rate, postoperative complications, recovery indicators, pathological outcomes, and lymph node dissection results.
The results of this study will provide preliminary clinical evidence regarding the role of split-type robotic technology in complex GEJ cancer surgery. These findings may serve as a foundation for future multicenter clinical trials, optimization of robotic surgical strategies, establishment of standardized surgical protocols, and improvement of clinical outcomes for patients with Siewert type II/III GEJ adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carina Robotic Surgery Group | Experimental | Procedure: Robotic-assisted radical resection for Siewert type II/III gastroesophageal junction cancerPatients with Siewert type II/III gastroesophageal junction adenocarcinoma who undergo radical surgical resection assisted by the Carina modular surgical robotic system. All participants will receive the same robotic surgical intervention, and perioperative safety, surgical outcomes, pathological outcomes, and short-term postoperative recovery will be evaluated prospectively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- Patients with body mass index (BMI) <18.5 kg/m² or BMI ≥35 kg/m².
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted radical resection for Siewert type II/III gastroesophageal junction cancerPatients will undergo totally robotic-assisted radical surgery for Siewert type II/III gastroesophageal junction cancer. The surgical procedure includes robotic-assisted tumor resection and lymph node dissection according to standard oncologic principles. | Procedure or surgery | Carina Robotic Surgery Group |
Primary outcome
Rate of Successful Completion of Robotic Surgery Without Conversion
Time frame: Intraoperatively
The proportion of patients who successfully complete radical resection using the Carina modular robotic surgical system without conversion to conventional laparoscopy or open surgery. Conversion includes unplanned transition to another surgical approach due to technical difficulties, intraoperative complications, or inability to complete the planned robotic procedure.
Incidence of Perioperative Complications (Clavien-Dindo Classification)
Time frame: Within 30 days after surgery
The incidence and severity of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo grading system. Complications include surgical and medical adverse events occurring during the perioperative period.
25 secondary outcomes
Achievement Rate of D2 Lymphadenectomy
Time frame: Perioperative/Periprocedural
Number and Metastatic Rate of Lymph Nodes in the Lower Mediastinal and Suprapancreatic Regions
Time frame: Within 14 days after surgery (pathological assessment)
Postoperative Pathological Stage (pTNM Classification)
Time frame: Within 14 days after surgery
R0 Resection Rate
Time frame: Within 14 days after surgery
Proximal and Distal Resection Margin Distance
Time frame: Within 14 days after surgery
Incidence of Specific Postoperative Complications
Time frame: Within 30 days after surgery
Estimated Intraoperative Blood Loss
Time frame: During the index operation
Device- and Instrument-related Adverse Events
Time frame: From surgery initiation to 30 days after surgery
Type of Gastrointestinal Reconstruction
Time frame: During surgery
30-day Postoperative Mortality
Time frame: Within 30 days after surgery
30-day Hospital Readmission Rate
Time frame: Within 30 days after surgery
ICU Admission Rate and Duration of ICU Stay
Time frame: From surgery until hospital discharge
Postoperative Hospital Stay
Time frame: From postoperative day 1 until hospital discharge
System Preparation Time
Time frame: Perioperative/Periprocedural
Robotic Arm Docking Time
Time frame: During surgery preparation
Robot-assisted Operative Time
Time frame: During surgery
Total Operative Time
Time frame: During surgery
Redocking Events and Duration
Time frame: Perioperative/Periprocedural
Surgical Interruption Events and Duration
Time frame: Perioperative/Periprocedural
Time to First Ambulation
Time frame: From completion of surgery until first postoperative ambulation
Time to First Postoperative Flatus
Time frame: From completion of surgery until first postoperative flatus
Time to Initiation of Liquid Diet
Time frame: From completion of surgery until initiation of oral liquid intake
Postoperative Pain Score
Time frame: Postoperative days 1-7
Surgeon Physical Workload Assessed by the Local Experienced Discomfort Scale
Time frame: Immediately after surgery
Surgeon Mental Workload Assessed by the Subjective Mental Effort Questionnaire
Time frame: Immediately after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study involves a relatively small patient population, and participant privacy and confidentiality considerations limit the sharing of individual-level data. Data may be available from the corresponding investigator upon reasonable request and subject to institutional and ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted radical resection for Siewert type II/III gastroesophageal junction cancer in people with Siewert Type II/III Gastroesophageal Junction Adenocarcinoma, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quan Wang (+86 15843073207, wquan@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Successful Completion of Robotic Surgery Without Conversion (time frame: Intraoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.