The Impact of COVID-19 Pandemic on Clinical Presentation and Staging of Gastric Cancer

NCT05130710 | Completed

• 1 other identifier: IR.TUMS.IKHC.REC.1399.414
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This was a retrospective case-control study designed and conducted under the approval of the ethic committee of Tehran University of Medical Sciences. All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were enrolled to the study.

Conditions

Gastric Cancer; COVID-19 Pandemic; Peritoneal Metastases

Outcome Measures

Primary Outcomes (1)

• presence of peritoneal seeding

  involvement of peritoneal cavity with metastatic gastric cancer.

  February 25th and December 25th 2020

Secondary Outcomes (1)

• presence of peri-gastric lymph node involvement

  February 25th and December 25th 2020

Study Arms (2)

case

26 patients with gastric cancer wo were referred to our center between February 25th to December 25th of 2020.

Procedure: staging laparoscopy

control

54 patients with gastric cancer wo were referred to our center between February 25th to December 25th of 2019.

Procedure: staging laparoscopy

Interventions

staging laparoscopy PROCEDURE

All patients of both groups underwent staging laparoscopy by the same two attending onco-surgeon, using the same technique and the same laparoscopic device. Under general anesthesia and in supine position SL was performed. A 10 mm optic laparoscopic port was inserted via the midline incision below the umbilicus using Hasson technique. All four quadrants of the abdomen as well as pelvis were inspected during laparoscopy and biopsy was taken from any suspicious lesion through insertion of 5mm port. All specimens underwent cytological evaluation by two independent pathologists. The presence of any malignant cells, regardless of the number, confirmed the positive cytology. In the event of discordant reports between two pathologists, specimens were sent for the third review by a pathologist who was blinded to the previous results. Laparoscopic evaluation was considered positive as if adjacent organ involvement, omental involvement or peritoneal seeding were seen.

case; control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with gastric cancer referring to Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran, during February 25th and December 25th 2020, were enrolled to the study.

You may qualify if:

• All patients became candidates to undergo staging laparoscopy (SL) in order to investigate local and peritoneal invasion of the tumor based on National Comprehensive Cancer Network guideline for gastric cancer 2020.

You may not qualify if:

• Patients with following criteria were excluded from the study; radiological evidence of metastatic disease, current or previous history of chemotherapy.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Cancer institute, Imam Khomeini Hospital Complex

Tehran, Iran

Location

Related Publications (9)

• Salari A, Jalaeefar A, Shirkhoda M. What is the best treatment option for head and neck cancers in COVID-19 pandemic? A rapid review. Am J Otolaryngol. 2020 Nov-Dec;41(6):102738. doi: 10.1016/j.amjoto.2020.102738. Epub 2020 Sep 18.

  PMID: 32979663 BACKGROUND

• Di Fiore F, Bouche O, Lepage C, Sefrioui D, Gangloff A, Schwarz L, Tuech JJ, Aparicio T, Lecomte T, Boulagnon-Rombi C, Lievre A, Manfredi S, Phelip JM, Michel P; Thesaurus National de Cancerologie Digestive (TNCD); Societe Nationale Francaise de Gastroenterologie (SNFGE); Federation Francophone de Cancerologie Digestive (FFCD); Groupe Cooperateur multidisciplinaire en Oncologie (GERCOR); Federation Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Societe Francaise de Chirurgie Digestive (SFCD); Societe Francaise d'Endoscopie Digestive (SFED); Societe Francaise de Radiotherapie Oncologique (SFRO) and Societe Francaise de Radiologie (SFR); Association Chirurgie Hepato-Biliaire et Transplantation (ACHBT). COVID-19 epidemic: Proposed alternatives in the management of digestive cancers: A French intergroup clinical point of view (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, SFR). Dig Liver Dis. 2020 Jun;52(6):597-603. doi: 10.1016/j.dld.2020.03.031. Epub 2020 May 14.

  PMID: 32418773 BACKGROUND

• Johnson BA, Waddimba AC, Ogola GO, Fleshman JW Jr, Preskitt JT. A systematic review and meta-analysis of surgery delays and survival in breast, lung and colon cancers: Implication for surgical triage during the COVID-19 pandemic. Am J Surg. 2021 Aug;222(2):311-318. doi: 10.1016/j.amjsurg.2020.12.015. Epub 2020 Dec 8.

  PMID: 33317814 BACKGROUND

• Wu JT, Kwon DH, Glover MJ, Henry S, Wood D, Rubin DL, Koshkin VS, Schapira L, Shah SA. Changes in Cancer Management due to COVID-19 Illness in Patients with Cancer in Northern California. JCO Oncol Pract. 2021 Mar;17(3):e377-e385. doi: 10.1200/OP.20.00790. Epub 2020 Dec 17.

  PMID: 33332170 BACKGROUND

• Zaniboni A, Ghidini M, Grossi F, Indini A, Trevisan F, Iaculli A, Dottorini L, Moleri G, Russo A, Vavassori I, Brevi A, Rausa E, Boni L, Dondossola D, Valeri N, Ghidini A, Tomasello G, Petrelli F. A Review of Clinical Practice Guidelines and Treatment Recommendations for Cancer Care in the COVID-19 Pandemic. Cancers (Basel). 2020 Aug 29;12(9):2452. doi: 10.3390/cancers12092452.

  PMID: 32872421 BACKGROUND

• Chan JW, Lee VHF. Will the COVID Pandemic Lead to Uncounted Cancer Deaths in the Future? Int J Radiat Oncol Biol Phys. 2020 Oct 1;108(2):351-352. doi: 10.1016/j.ijrobp.2020.07.003. No abstract available.

  PMID: 32890510 BACKGROUND

• Vanni G, Tazzioli G, Pellicciaro M, Materazzo M, Paolo O, Cattadori F, Combi F, Papi S, Pistolese CA, Cotesta M, Santori F, Caspi J, Chiaravalloti A, Muscoli S, Lombardo V, Grasso A, Caggiati L, Raselli R, Palli D, Altomare V, D'Angelillo RM, Palombi L, Buonomo OC. Delay in Breast Cancer Treatments During the First COVID-19 Lockdown. A Multicentric Analysis of 432 Patients. Anticancer Res. 2020 Dec;40(12):7119-7125. doi: 10.21873/anticanres.14741. Epub 2020 Dec 7.

  PMID: 33288611 BACKGROUND

• Gundavda MK, Gundavda KK. Cancer or COVID-19? A Review of Guidelines for Safe Cancer Care in the Wake of the Pandemic. SN Compr Clin Med. 2020;2(12):2691-2701. doi: 10.1007/s42399-020-00632-2. Epub 2020 Nov 21.

  PMID: 33251481 BACKGROUND

• Arpino G, De Angelis C, De Placido P, Pietroluongo E, Formisano L, Bianco R, Fiore G, Montella E, Forestieri V, Lauria R, Cardalesi C, Vozzella EA, Iervolino A, Giuliano M, De Placido S. Optimising triage procedures for patients with cancer needing active anticancer treatment in the COVID-19 era. ESMO Open. 2020 Sep;5(5):e000885. doi: 10.1136/esmoopen-2020-000885.

  PMID: 32958531 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

in time of performing staging laparoscopy if any suspicious tissue for being malignant was encounter biopsied.

MeSH Terms

Conditions

Stomach Neoplasms; COVID-19

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: November 23, 2021
• Study Start: February 25, 2020
• Primary Completion: December 25, 2020
• Study Completion: February 25, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IR (1)