NCT05545293Completed
Prospective Study on Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers
Safety and Feasibility of Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
The purpose of this study is to explore the clinical application value of Double-Stapling End-to-End Gastroduodenostomy Billroth-I Anastomosis in Laparoscopy-Assisted Surgery for Locally Advanced Distal Gastric Cancers.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 14 Sept 2022
- Start date
- 14 Sept 2017
- Primary completion date
- 6 Dec 2025
- Lead sponsor
- West China Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05545293
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 14 Sept 2017 to the primary completion date, 6 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous upper abdominal surgery (include ESD/EMR, except laparoscopic cholecystectomy)
- Peritoneal implant or other distant metastases by intraoperative exploration
- Duodenal bulb has been invaded by tumor or gastroduodenostomy cannot be performed due to additional surgical resection cause by positive intraoperative frozen margin
Other illness
- History of acute pancreatitis
- History of other malignant disease within past five years
- History of unstable angina, myocardial infarction, cerebral infraction, or cerebral hemorrhage within past six months
- History of continuous systematic corticosteroids therapy within past one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, or perforation) caused by gastric cancer
- Severe mental disorder
- Distal gastric cancer surgery cannot be performed after intraoperative exploration
Other
- Regional fusion of enlarged lymph nodes by preoperative imaging (maximum diameter \>3cm)
- FEV1\<50% of predicted values by pulmonary function test
- Women during pregnancy or breast-feeding
- Participating in other clinical studies simultaneously
- Refusing to sign the informed consent for the study
- Unresectable due to tumor reasons by intraoperative exploration
Who the study is looking for
- Age from 18 to years (including 18 and 85years old)
- Pathological diagnosis of primary focus is gastric adenocarcinoma made by endoscopic biopsy (papillary, tubular, mucinous, signet ring cell, poorly differentiated)
- cT1-4a, N+/-, M0 at preoperative evaluation
- No peritoneal metastasis or other distant metastases of gastric carcinoma (affirmed by laparoscopic surgery and related imaging examinations)
- Expected curative resection through laparoscopic distal gastrectomy with D2 lymphadenectomy (include multiple primary lower gastric adenocarcinoma)
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- Preoperative American Society of Anesthesiology score (ASA) classⅠ, Ⅱ or Ⅲ
- Major organs are functioning normally:
- blood routine test (No blood transfusions in the last 14 days): HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L blood biochemical examination: BIL\<1.5× upper limit of normal (ULN), ALT and AST\<2.5×ULN, Crea≤1×ULN.
- \- The subject is willing to participate in this clinical trail
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.