Gastrointestinal neoplasms and neoplasm-like lesions (including gastric, duodenal, and colorectal lesions), with a focus on high-risk and complex gastrointestinal lesions.
Conditions
Interventions
Gastric cohort:Combined endoscopic–laparoscopic surgery for gastric lesions
Colorectal cohort:Combined endoscopic–laparoscopic surgery for colorectal lesions
Duodenal cohort:Combined endoscopic–laparoscopic surgery for duodenal lesions
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–80 years, regardless of sex. 2.Diagnosed with gastrointestinal neoplasms or neoplasm-like lesions, and scheduled by the operator for dual-endoscopy minimally invasive treatment. Cases are considered “high-risk/complex” if conventional endoscopic treatment alone (e.g., EMR/ESD/EFTR) is expected to carry excessive risk or cannot be completed safely; 3.Lesions located in the stomach, duodenum, or colorectum. 4.Preoperative evaluation (endoscopic assessment with or without EUS/CT/MRI as appropriate) indicates localized disease without evidence of distant metastasis. 5.Considered fit to tolerate the planned procedure on anesthesia evaluation (ASA I–III or deemed feasible by the anesthesiology team). 6.Able to complete follow-up. 7.The subject or legally authorized representative voluntarily agrees to participate in the study and signs written informed consent.
Exclusion criteria
Exclusion criteria: 1.Definite or highly suspected advanced malignancy requiring standard radical resection and/or systematic lymph node dissection. 2.Imaging evidence of distant metastasis, peritoneal dissemination, or multiple unresectable lesions. 3.Judged preoperatively to be amenable to conventional endoscopic treatment alone (e.g., EMR/ESD/conventional closure) without surgical collaboration, with acceptable anticipated complication risk. 4.Severe cardiac, pulmonary, hepatic, or renal dysfunction, or other conditions rendering the patient unable to tolerate anesthesia/surgery (e.g., ASA = IV or deemed unsuitable by the anesthesiology team). 5.Uncorrectable coagulation dysfunction. 6.Inability to discontinue anticoagulant/antiplatelet therapy according to standard requirements, with unacceptable bleeding risk on assessment. 7.Active severe infection or unstable general condition. 8.Pregnancy or lactation. 9.Inability to provide informed consent or to comply with study procedures/follow-up. 10.Any other condition judged by the investigators to make the patient unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse events (SAEs) within 30 days after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional treatment rate;Residual/local recurrence rate;R0 resection rate;Total procedure time;Stricture/obstruction requiring intervention;30-day readmission rate;Length of hospital stay;Intraoperative perforation;Planned procedure completion rate;Intraoperative blood loss;Infection/intra-abdominal abscess;Immediate bleeding;Conversion/escalation treatment rate and reasons;Time to first oral intake after surgery;Delayed perforation;En bloc resection rate;Delayed bleeding; | — |
Countries
China
Contacts
Public ContactWang Qiang
Peking Union Medical College Hospital
Outcome results
None listed