NCT02845986

Brief Summary

The purpose of this study is to explore the safety and feasibility of the Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
251

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2016

Typical duration for phase_2

Geographic Reach
1 country

20 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2020

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

July 15, 2016

Last Update Submit

February 4, 2020

Conditions

Stomach Neoplasms

Keywords

Stomach NeoplasmsLaparoscopySpleen-PreservingNo.10 Lymph Node Dissection

Outcome Measures

Primary Outcomes (1)

  • overall postoperative morbidity rates

    Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.

    30 days

Secondary Outcomes (22)

  • Numbers of No.10 lymph node dissection

    9 days

  • Rates of positive No.10 lymph node

    9 days

  • 3-year overall survival rate

    36 months

  • 3-year disease free survival rate

    36 months

  • 3-year recurrence pattern

    36 months

  • +17 more secondary outcomes

Study Arms (1)

No.10 lymph node dissections

EXPERIMENTAL

Patients with locally advanced upper third gastric carcinoma will performed laparoscopic spleen-preserving No.10 lymph node dissections.After the surgery the patients will be treated with oxaliplatin or platinum-based chemotherapy.

Procedure: Laparoscopic Spleen-Preserving No.10 Lymph Node DissectionsDrug: oxaliplatin

Interventions

Laparoscopic Spleen-Preserving No.10 Lymph Node DissectionsPROCEDURE

After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Laparoscopic spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma.

No.10 lymph node dissections
oxaliplatinDRUG

oxaliplatin or platinum-based chemotherapy is used when the patients undergo adjuvant chemotherapy after the surgery.

Also known as: platinum-based chemotherapy
No.10 lymph node dissections

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 to 75 years old
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • Locally advanced tumor in the upper third stomach（cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
  • No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
  • Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  • ASA (American Society of Anesthesiology) class I to III
  • Written informed consent

You may not qualify if:

  • Pregnant and lactating women
  • Suffering from severe mental disorder
  • History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
  • History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
  • Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
  • History of other malignant disease within the past 5 years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within the past 6 months
  • History of cerebrovascular accident within the past 6 months
  • History of continuous systematic administration of corticosteroids within 1 month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1\<50% of the predicted values
  • Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen blood vessels.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Beijing Cancer Hospital

Haidian, Beijing Municipality, 100142, China

Location

Southwest Hospital

Shapingba, Chongqing Municipality, 400038, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

Longyan First Hospital

Longyan, Fujian, 364000, China

Location

The First Hospital of Putian City

Putian, Fujian, 351100, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, 363000, China

Location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Meizhou People's Hospital

Meizhou, Guangdong, 514031, China

Location

Jiangsu province hospital

Nanjing, Jiangsu, 210029, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

Location

Qinghai University Affiliated Hospital

Xining, Qinghai, 810001, China

Location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Pudong, Shanghai Municipality, 200135, China

Location

Shanghai Zhongshan Hospital

Xuhui, Shanghai Municipality, 200032, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, Xinjiang, 830054, China

Location

Related Publications (23)

  • Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. No abstract available.

    PMID: 21573742RESULT

  • Monig SP, Collet PH, Baldus SE, Schmackpfeffer K, Schroder W, Thiele J, Dienes HP, Holscher AH. Splenectomy in proximal gastric cancer: frequency of lymph node metastasis to the splenic hilus. J Surg Oncol. 2001 Feb;76(2):89-92. doi: 10.1002/1096-9098(200102)76:23.0.co;2-i.

    PMID: 11223832RESULT

  • Chikara K, Hiroshi S, Masato N, Goro M, Yuichi O, Hidetaka O, Hirotoshi A. Association of the number of metastatic perigastric lymph nodes with long-term survival in gastric cancer. Hepatogastroenterology. 2005 Jan-Feb;52(61):277-80.

    PMID: 15783049RESULT

  • Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, Meyer S, Plukker JT, Van Elk P, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999 Mar 25;340(12):908-14. doi: 10.1056/NEJM199903253401202.

    PMID: 10089184RESULT

  • Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.

    PMID: 8180768RESULT

  • Hyung WJ, Lim JS, Song J, Choi SH, Noh SH. Laparoscopic spleen-preserving splenic hilar lymph node dissection during total gastrectomy for gastric cancer. J Am Coll Surg. 2008 Aug;207(2):e6-11. doi: 10.1016/j.jamcollsurg.2008.04.027. No abstract available.

    PMID: 18656040RESULT

  • Okabe H, Obama K, Kan T, Tanaka E, Itami A, Sakai Y. Medial approach for laparoscopic total gastrectomy with splenic lymph node dissection. J Am Coll Surg. 2010 Jul;211(1):e1-6. doi: 10.1016/j.jamcollsurg.2010.04.006. No abstract available.

    PMID: 20610241RESULT

  • Hur H, Jeon HM, Kim W. Laparoscopic pancreas- and spleen-preserving D2 lymph node dissection in advanced (cT2) upper-third gastric cancer. J Surg Oncol. 2008 Feb 1;97(2):169-72. doi: 10.1002/jso.20927.

    PMID: 18095269RESULT

  • Schwarz RE. Spleen-preserving splenic hilar lymphadenectomy at the time of gastrectomy for cancer: technical feasibility and early results. J Surg Oncol. 2002 Jan;79(1):73-6. doi: 10.1002/jso.10036. No abstract available.

    PMID: 11754382RESULT

  • Tanimura S, Higashino M, Fukunaga Y, Kishida S, Ogata A, Fujiwara Y, Osugi H. Laparoscopic gastrectomy with regional lymph node dissection for upper gastric cancer. Br J Surg. 2007 Feb;94(2):204-7. doi: 10.1002/bjs.5542.

    PMID: 17058319RESULT

  • Huang CM, Chen QY, Lin JX, Zheng CH, Li P, Xie JW. Huang's three-step maneuver for laparoscopic spleen-preserving No. 10 lymph node dissection for advanced proximal gastric cancer. Chin J Cancer Res. 2014 Apr;26(2):208-10. doi: 10.3978/j.issn.1000-9604.2014.04.05.

    PMID: 24826062RESULT

  • Jung MR, Park YK, Seon JW, Kim KY, Cheong O, Ryu SY. Definition and classification of complications of gastrectomy for gastric cancer based on the accordion severity grading system. World J Surg. 2012 Oct;36(10):2400-11. doi: 10.1007/s00268-012-1693-y.

    PMID: 22752074RESULT

  • Orsenigo E, Bissolati M, Socci C, Chiari D, Muffatti F, Nifosi J, Staudacher C. Duodenal stump fistula after gastric surgery for malignancies: a retrospective analysis of risk factors in a single centre experience. Gastric Cancer. 2014 Oct;17(4):733-44. doi: 10.1007/s10120-013-0327-x. Epub 2014 Jan 8.

    PMID: 24399492RESULT

  • Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.

    PMID: 16003309RESULT

  • Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.

    PMID: 11091234RESULT

  • Asgeirsson T, El-Badawi KI, Mahmood A, Barletta J, Luchtefeld M, Senagore AJ. Postoperative ileus: it costs more than you expect. J Am Coll Surg. 2010 Feb;210(2):228-31. doi: 10.1016/j.jamcollsurg.2009.09.028. Epub 2009 Nov 18.

    PMID: 20113944RESULT

  • Arozullah AM, Khuri SF, Henderson WG, Daley J; Participants in the National Veterans Affairs Surgical Quality Improvement Program. Development and validation of a multifactorial risk index for predicting postoperative pneumonia after major noncardiac surgery. Ann Intern Med. 2001 Nov 20;135(10):847-57. doi: 10.7326/0003-4819-135-10-200111200-00005.

    PMID: 11712875RESULT

  • Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8. No abstract available.

    PMID: 1334988RESULT

  • Dong K, Yu XJ, Li B, Wen EG, Xiong W, Guan QL. Advances in mechanisms of postsurgical gastroparesis syndrome and its diagnosis and treatment. Chin J Dig Dis. 2006;7(2):76-82. doi: 10.1111/j.1443-9573.2006.00255.x.

    PMID: 16643334RESULT

  • Kaas R, Rustman LD, Zoetmulder FA. Chylous ascites after oncological abdominal surgery: incidence and treatment. Eur J Surg Oncol. 2001 Mar;27(2):187-9. doi: 10.1053/ejso.2000.1088.

    PMID: 11289756RESULT

  • Assumpcao L, Cameron JL, Wolfgang CL, Edil B, Choti MA, Herman JM, Geschwind JF, Hong K, Georgiades C, Schulick RD, Pawlik TM. Incidence and management of chyle leaks following pancreatic resection: a high volume single-center institutional experience. J Gastrointest Surg. 2008 Nov;12(11):1915-23. doi: 10.1007/s11605-008-0619-3. Epub 2008 Aug 7.

    PMID: 18685899RESULT

  • Greenblatt DY, Kelly KJ, Rajamanickam V, Wan Y, Hanson T, Rettammel R, Winslow ER, Cho CS, Weber SM. Preoperative factors predict perioperative morbidity and mortality after pancreaticoduodenectomy. Ann Surg Oncol. 2011 Aug;18(8):2126-35. doi: 10.1245/s10434-011-1594-6. Epub 2011 Feb 20.

    PMID: 21336514RESULT

  • Xu BB, Zheng HL, Chen CS, Xu LL, Xue Z, Wei LH, Zheng HH, Shen LL, Zheng CH, Li P, Xie JW, Lin JX, Zheng YH, Huang CM. Development and validation of a preoperative radiomics-based nomogram to identify patients who can benefit from splenic hilar lymphadenectomy: a pooled analysis of three prospective trials. Int J Surg. 2024 Jul 1;110(7):4053-4061. doi: 10.1097/JS9.0000000000001337.

    PMID: 38980664DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

OxaliplatinPlatinum Compounds

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsInorganic Chemicals

Study Officials

  • Changming Huang, Professor

    Fujian Medical University Union Hospital,China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 27, 2016

Study Start

September 1, 2016

Primary Completion

October 12, 2017

Study Completion

October 12, 2020

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available.

Locations

CN(20)