Clinical trial · Observational
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
NCT05545293CI-TRIAL-00114489completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Carcinoma | Gastric Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Anastomotic complications
- timeFrame
- up to 1-30 Days after surgery
- description
- The anastomotic complications are defined as the event observed within 30 days after surgery, including anastomotic stenosis, anastomotic bleeding, and anastomotic leakage.
- measure
- Intraoperative situation
- timeFrame
- on the day of surgery
- description
- Operation time, anastomotic reconstruction time, operative blood loss, completed proportion of laparoscopic surgery, positive rate of Intraoperative frozen margin pathology, anastomotic tension, the distance between proximal and distal of resection margin, the incidence of complication in surgery are used to access the intraoperative situation.
- measure
- Postoperative nutritional status and quality of life
- timeFrame
- up to 1-30 Days after surgery
- description
- The variation of weight, cholesterol and albumin on postoperative 30 days are used to access the postoperative nutritional status and quality of life.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * History of previous upper abdominal surgery (include ESD/EMR, except laparoscopic cholecystectomy) * History of acute pancreatitis * Regional fusion of enlarged lymph nodes by preoperative imaging (maximum diameter \>3cm) * 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 * FEV1\<50% of predicted values by pulmonary function test * Women during pregnancy or breast-feeding * Severe mental disorder * Participating in other clinical studies simultaneously * Refusing to sign the informed consent for the study * Peritoneal implant or other distant metastases by intraoperative exploration * Unresectable due to tumor reasons by intraoperative exploration * Distal gastric cancer surgery cannot be performed after 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
References
Publications (10)
- RESULTNishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2. PMID 34523717
- RESULTJapanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available. PMID 32060757
- RESULTCai Z, Zhou Y, Wang C, Yin Y, Yin Y, Shen C, Yin X, Chen Z, Zhang B. Optimal reconstruction methods after distal gastrectomy for gastric cancer: A systematic review and network meta-analysis. Medicine (Baltimore). 2018 May;97(20):e10823. doi: 10.1097/MD.0000000000010823. PMID 29768387
- RESULTJin HE, Kim MS, Lee CM, Park JH, Choi CI, Lee HH, Min JS, Jee YS, Oh J, Chae H, Choi SI, Lee YT, Kim JH, Huang H, Park S. Meta-analysis and systematic review on laparoscopic-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer: Preliminary study for a multicenter prospective KLASS07 trial. Eur J Surg Oncol. 2019 Dec;45(12):2231-2240. doi: 10.1016/j.ejso.2019.06.030. Epub 2019 Jun 22. PMID 31262598
- RESULTKanaya S, Gomi T, Momoi H, Tamaki N, Isobe H, Katayama T, Wada Y, Ohtoshi M. Delta-shaped anastomosis in totally laparoscopic Billroth I gastrectomy: new technique of intraabdominal gastroduodenostomy. J Am Coll Surg. 2002 Aug;195(2):284-7. doi: 10.1016/s1072-7515(02)01239-5. No abstract available. PMID 12168979
- RESULTLin M, Zheng CH, Huang CM, Li P, Xie JW, Wang JB, Lin JX, Lu J, Chen QY, Cao LL, Tu RH. Totally laparoscopic versus laparoscopy-assisted Billroth-I anastomosis for gastric cancer: a case-control and case-matched study. Surg Endosc. 2016 Dec;30(12):5245-5254. doi: 10.1007/s00464-016-4872-3. Epub 2016 Mar 23.