Long-term Oncologic Outcomes of Robotic Versus Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

NCT05181306 | Completed

• 1 other identifier: KY2021123
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a retrospective, single-center, controlled and observation trial comparing robotic total gastrectomy with D2 lymph nodal dissection for locally advanced gastric cancer patients with laparoscopic procedure.

Conditions

Gastric Cancer

Keywords

Advanced gastric cancer; Total gastrectomy; Robotic; Laparoscopic; Long-term outcomes

Outcome Measures

Primary Outcomes (3)

• 5-year Overall survival rate

  5-year Overall survival rate

  5 years

• 5-year Disease-free survival rate

  5-year Disease-free survival rate

  5 years

• Recurrence

  Recurrence

  5 years

Secondary Outcomes (11)

• Overall postoperative morbidity and mortality

  30 days

• Time of operation

  1 day

• Estimated blood loss

  1 day

• Blood transfusion

  1 day

• Length of proximal and distal cutting margin

  1 day

Study Arms (2)

Robotic surgery

Procedure: Robotic-assisted Total Gastrectomy with D2 Lymphadenectomy

Laparoscopic surgery

Procedure: Laparoscopic-assisted Total Gastrectomy with D2 Lymphadenectomy

Interventions

Robotic-assisted Total Gastrectomy with D2 Lymphadenectomy PROCEDURE

Robotic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose robotic-assisted total gastrectomy and excluding T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.

Robotic surgery

Laparoscopic-assisted Total Gastrectomy with D2 Lymphadenectomy PROCEDURE

Laparoscopic-assisted total gastrectomy with D2 lymph node dissection will be performed with curative treated intent according to the patients' or their legal representatives'willing to choose laparoscopic-assisted total gastrectomy and excluding T4b、bulky lymph nodes or distant metastasis case by diagnostic laparoscopy. The alimentary canal reconstruction method is selected as esophageal jejunal R-Y anastomosis. Whether to reinforce the anastomotic manually is decided by the surgeon's experience. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.

Laparoscopic surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with gastric cancer who need to received total gastrectomy with D2 lymphadenectomy.

You may qualify if:

• Pathologically proven gastric adenocarcinoma; 2.Age: older than 18 years old, younger than 80 years old; 3.Tumor located in the upper third of the stomach or esophagogastric junction or other location, and is possible to be curatively resected by total gastrectomy; 4.Preoperative stage of cT2-4aN0-3M0 according to American Joint Committee on Cancer/Union for International Cancer Control 8th edition; 5.American Society of Anesthesiology (ASA) score of class I to III; 6.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7.Patients who freely give informed consent to participate in the clinical study;

You may not qualify if:

• Early gastric cancer; 2.Age: younger than 18 years old, older than 80 years old; 3.Total gastrectomy with D2 lymphadenectomy was not required; 4.Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging; 5.Emergency surgery for gastric cancer-related complications (bleeding or complete obstruction or perforation); 6.Previous upper abdominal surgery (except laparoscopic cholecystectomy); 7.Previous neoadjuvant chemotherapy or radiotherapy for gastric cancer; 8.Unstable angina or myocardial infarction within the past 6 months; 9.Cerebrovascular accident within the past 6 months; 10.American Society of Anesthesiology (ASA) score of class more than III; 11.Severe respiratory disease (FEV1\< 50%); 12.Continuous systemic steroid therapy within 1 month before the study; 13.Pregnant or breast-feeding women;

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Unknown Facility

Chongqing, Chongqing Municipality, 400038, China

Location

Related Publications (8)

• Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.

  PMID: 27342689 BACKGROUND

• Etoh T, Honda M, Kumamaru H, Miyata H, Yoshida K, Kodera Y, Kakeji Y, Inomata M, Konno H, Seto Y, Kitano S, Hiki N. Morbidity and mortality from a propensity score-matched, prospective cohort study of laparoscopic versus open total gastrectomy for gastric cancer: data from a nationwide web-based database. Surg Endosc. 2018 Jun;32(6):2766-2773. doi: 10.1007/s00464-017-5976-0. Epub 2017 Dec 7.

  PMID: 29218676 BACKGROUND

• Yoon HM, Kim YW, Lee JH, Ryu KW, Eom BW, Park JY, Choi IJ, Kim CG, Lee JY, Cho SJ, Rho JY. Robot-assisted total gastrectomy is comparable with laparoscopically assisted total gastrectomy for early gastric cancer. Surg Endosc. 2012 May;26(5):1377-81. doi: 10.1007/s00464-011-2043-0. Epub 2011 Nov 16.

  PMID: 22083338 BACKGROUND

• Son T, Lee JH, Kim YM, Kim HI, Noh SH, Hyung WJ. Robotic spleen-preserving total gastrectomy for gastric cancer: comparison with conventional laparoscopic procedure. Surg Endosc. 2014 Sep;28(9):2606-15. doi: 10.1007/s00464-014-3511-0. Epub 2014 Apr 3.

  PMID: 24695982 BACKGROUND

• Shen W, Xi H, Wei B, Cui J, Bian S, Zhang K, Wang N, Huang X, Chen L. Robotic versus laparoscopic gastrectomy for gastric cancer: comparison of short-term surgical outcomes. Surg Endosc. 2016 Feb;30(2):574-580. doi: 10.1007/s00464-015-4241-7. Epub 2015 Jul 25.

  PMID: 26208497 BACKGROUND

• Pan HF, Wang G, Liu J, Liu XX, Zhao K, Tang XF, Jiang ZW. Robotic Versus Laparoscopic Gastrectomy for Locally Advanced Gastric Cancer. Surg Laparosc Endosc Percutan Tech. 2017 Dec;27(6):428-433. doi: 10.1097/SLE.0000000000000469.

  PMID: 29211699 BACKGROUND

• Junfeng Z, Yan S, Bo T, Yingxue H, Dongzhu Z, Yongliang Z, Feng Q, Peiwu Y. Robotic gastrectomy versus laparoscopic gastrectomy for gastric cancer: comparison of surgical performance and short-term outcomes. Surg Endosc. 2014 Jun;28(6):1779-87. doi: 10.1007/s00464-013-3385-6. Epub 2014 Jan 3.

  PMID: 24385251 BACKGROUND

• Wang W, Zhang X, Shen C, Zhi X, Wang B, Xu Z. Laparoscopic versus open total gastrectomy for gastric cancer: an updated meta-analysis. PLoS One. 2014 Feb 18;9(2):e88753. doi: 10.1371/journal.pone.0088753. eCollection 2014.

  PMID: 24558421 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Pei-wu Yu

  Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery,Southwest Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of General Surgery

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 6, 2022
• Study Start: October 1, 2010
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2016
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)