A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuashan Hospital
About this trial
This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).
The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.
Eligibility criteria
Qualifiers
Age between 18 and 75 years old;
Pathologically confirmed as adenocarcinoma;
Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
Disqualifiers
Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
Pregnant or lactating women;
Patients with severe mental illness;
Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
Trial design
Treatments tested in this trial
- Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov