Severe Complications After Gastrectomy for Esophagogastric Junction and Gastric Cancer
NCT ID: NCT03909997
Last Updated: 2019-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2019-04-05
2022-04-05
Brief Summary
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Detailed Description
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This was a retrospective cohort study. The investigators included patients treated with gastrectomy for gastric or EGJ cancers at a single center. Severe morbidity was defined as Clavien-Dindo score ≥3.
The following factors are analyzed: age, sex, comorbidity, American Society of Anesthesiologists (ASA) physical status, tobacco and alcohol consumption, body mass index (BMI), hematocrit, serum albumin level, tumor location, the use of preoperative chemotherapy, laparoscopic or open surgery, total or subtotal gastrectomy, duodenal stump closure, multi-organ resection, lymphadenectomy, reconstruction method, T status, lymph node metastasis, and resection margin. The T stage was grouped by T1-T2 and T3-T4 for analysis. Patients will be followed for 5 years after surgery for survival analysis. A multivariate analysis is performed to identify predictors of overall and severe morbidity; and predictors of long-term survival.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Confirmed adenocarcinoma histology.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hospital Dr Sotero del Rio
OTHER
Responsible Party
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Principal Investigators
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Enrique M Norero, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Sotero Del Rio
Locations
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Hospital Sotero del Rio
Santiago, RM, Chile
Countries
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Central Contacts
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Facility Contacts
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References
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Park DJ, Lee HJ, Kim HH, Yang HK, Lee KU, Choe KJ. Predictors of operative morbidity and mortality in gastric cancer surgery. Br J Surg. 2005 Sep;92(9):1099-102. doi: 10.1002/bjs.4952.
Onate-Ocana LF, Cortes-Cardenas SA, Aiello-Crocifoglio V, Mondragon-Sanchez R, Ruiz-Molina JM. Preoperative multivariate prediction of morbidity after gastrectomy for adenocarcinoma. Ann Surg Oncol. 2000 May;7(4):281-8. doi: 10.1007/s10434-000-0281-9.
Bartlett EK, Roses RE, Kelz RR, Drebin JA, Fraker DL, Karakousis GC. Morbidity and mortality after total gastrectomy for gastric malignancy using the American College of Surgeons National Surgical Quality Improvement Program database. Surgery. 2014 Aug;156(2):298-304. doi: 10.1016/j.surg.2014.03.022. Epub 2014 Mar 16.
Kim TH, Suh YS, Huh YJ, Son YG, Park JH, Yang JY, Kong SH, Ahn HS, Lee HJ, Slankamenac K, Clavien PA, Yang HK. The comprehensive complication index (CCI) is a more sensitive complication index than the conventional Clavien-Dindo classification in radical gastric cancer surgery. Gastric Cancer. 2018 Jan;21(1):171-181. doi: 10.1007/s10120-017-0728-3. Epub 2017 Jun 8.
Lee KG, Lee HJ, Yang JY, Oh SY, Bard S, Suh YS, Kong SH, Yang HK. Risk factors associated with complication following gastrectomy for gastric cancer: retrospective analysis of prospectively collected data based on the Clavien-Dindo system. J Gastrointest Surg. 2014 Jul;18(7):1269-77. doi: 10.1007/s11605-014-2525-1. Epub 2014 May 13.
Kikuchi H, Miyata H, Konno H, Kamiya K, Tomotaki A, Gotoh M, Wakabayashi G, Mori M. Development and external validation of preoperative risk models for operative morbidities after total gastrectomy using a Japanese web-based nationwide registry. Gastric Cancer. 2017 Nov;20(6):987-997. doi: 10.1007/s10120-017-0706-9. Epub 2017 Mar 11.
Norero E, Vega EA, Diaz C, Cavada G, Ceroni M, Martinez C, Briceno E, Araos F, Gonzalez P, Baez S, Vinuela E, Caracci M, Diaz A. Improvement in postoperative mortality in elective gastrectomy for gastric cancer: Analysis of predictive factors in 1066 patients from a single centre. Eur J Surg Oncol. 2017 Jul;43(7):1330-1336. doi: 10.1016/j.ejso.2017.01.004. Epub 2017 Feb 10.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
Hayashi T, Yoshikawa T, Aoyama T, Ogata T, Cho H, Tsuburaya A. Severity of complications after gastrectomy in elderly patients with gastric cancer. World J Surg. 2012 Sep;36(9):2139-45. doi: 10.1007/s00268-012-1653-6.
Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346.
Climent M, Hidalgo N, Vidal O, Puig S, Iglesias M, Cuatrecasas M, Ramon JM, Garcia-Albeniz X, Grande L, Pera M. Postoperative complications do not impact on recurrence and survival after curative resection of gastric cancer. Eur J Surg Oncol. 2016 Jan;42(1):132-9. doi: 10.1016/j.ejso.2015.08.163. Epub 2015 Sep 3.
Tokunaga M, Tanizawa Y, Bando E, Kawamura T, Terashima M. Poor survival rate in patients with postoperative intra-abdominal infectious complications following curative gastrectomy for gastric cancer. Ann Surg Oncol. 2013 May;20(5):1575-83. doi: 10.1245/s10434-012-2720-9. Epub 2012 Oct 18.
Kubota T, Hiki N, Sano T, Nomura S, Nunobe S, Kumagai K, Aikou S, Watanabe R, Kosuga T, Yamaguchi T. Prognostic significance of complications after curative surgery for gastric cancer. Ann Surg Oncol. 2014 Mar;21(3):891-8. doi: 10.1245/s10434-013-3384-9. Epub 2013 Nov 20.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id
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