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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130710
• Other study ID #: IR.TUMS.IKHC.REC.1399.414
• Status: Completed
• Start date: February 25, 2020
• Est. completion date: February 25, 2021

Study information

• Verified date: November 2021
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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. February 25th was the day Ministry of Health and Medical Education announced COVID-19 as a national disaster and set restrictive rules of social distancing. The control group consisted of the gastric cancer patients whom referred to Cancer Institute during February 25th and December 25th of 2019. So the investigators compared two groups of gastric cancer patients one in the era of COVID-19 pandemic and other group from previous year when there was no COVID-19.

Cancer Institute as the pioneer of cancer management in Iran set institutional regulation for hospitalization of cancer patients during COVID-19 pandemic with the primary goal of delivering the best available treatment as timely as possible. In order to achieve this, each patient regardless of cancer type must had proceeded these steps before elective hospitalization and during preoperative, operation and postoperative days:

1. Prior to hospitalization, patients were referred to infectious disease clinic, where they were visited by attending infectious disease specialists who had fellowship in infectious disease of immunocompromised and transplanted patients. Every patient monitored for COVID-19 sign and symptoms and those with high susceptibility were examined utilizing spiral chest computed tomography scan (SCCT) and polymerase chain reaction (PCR) for SARS-CoV-2. If a patient had positive result of either SCCT or PCR, he/she was managed either in outpatient or inpatient setting for COVID-19 treatment based on national protocol and subsequent cancer management was postponed. If it was confirmed that patient is eligible for hospitalization and entering operation room, he/she was admitted to surgical oncology ward.

2. During pre-operative days, all patients were hospitalized in single or double bed room, family members were not allowed to accompany except for under legal aged patient and those who need special attention because of the low performance status. All patients were educated about COVID-19 transmission routs and preventive measures and asked to respect social distancing, wear facial mask and wash hands using alcohol- based antiseptic formulas given. Each patient underwent daily monitoring for sign and symptoms of COVID-19, heart rate, blood pressure, temperature and oxygen saturation by commercially available pulse oximetry devices. In case of developing signs and symptoms related to COVID-19 or unexplained temperature > 38°C, oxygen saturation < 93% or > 5 unit drop in oxygen saturation from the baseline, infectious disease consultation was ordered.

3. During operation time, the minimum number of personnel needed to activate a safe operation environment whom were fully equipped with personal preventive clothing including surgical cap, gown, facial mask and shield were present at the theater. The operation theater was well ventilated.

4. During post-operative days, for both intensive care unit and ward patient, daily monitoring of signs and symptoms related to COVID-19 besides unexplained temperature > 38°C, oxygen saturation < 93% or > 5 unit drop in oxygen saturation from the baseline, C-Reactive Protein Level > 40 persistent for 3 days activated infectious disease consultation.

Patients of both case and control group were enrolled to the study as if they gave written consent of participation, had confirmed gastric cancer using esophago-gastro-duodenoscopy and pathologically proven biopsy and spiral thoraco-abdomino-pelvic computed tomography scan prior to surgery. 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. Patients with following criteria were excluded from the study; radiological evidence of metastatic disease, current or previous history of chemotherapy.

All patients of both groups underwent SL 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.

Data were collected on the following variables: age, gender, tumor location, gastric lesion pathology and clinical stage based on the 8th edition of the American Joint Committee on Cancer tumor-node metastasis staging system for gastric cancer[16].

Categorical variables are shown as number and relative frequency. Also, continuous variables are shown as mean ± SD. Collected data for categorical variables were compared using the chi-squared test. An independent student t-test was used to compare means between the two groups. All analyses were performed by the two-sided method using Statistical Package of Social Science software (SPSS version 22; SPSS, Inc., Chicago, IL), and the p-value of < 0.05 was set as statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 25, 2021
• Est. primary completion date: December 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic
• Gastric Cancer
• Peritoneal Metastases
• Stomach Neoplasms

Intervention

Procedure:
• staging laparoscopy
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Cancer institute, Imam Khomeini Hospital Complex	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (9)

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. — View Citation

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. — View Citation

Di Fiore F, Bouché O, Lepage C, Sefrioui D, Gangloff A, Schwarz L, Tuech JJ, Aparicio T, Lecomte T, Boulagnon-Rombi C, Lièvre A, Manfredi S, Phelip JM, Michel P; Thésaurus National de Cancérologie Digestive (TNCD); Société Nationale Française de Gastroentérologie (SNFGE); Fédération Francophone de Cancérologie Digestive (FFCD); Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR); Fédération Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Société Française de Chirurgie Digestive (SFCD); Société Française d'Endoscopie Digestive (SFED); Société Française de Radiothérapie Oncologique (SFRO) and Société Française 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. — View Citation

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 Nov 21:1-11. doi: 10.1007/s42399-020-00632-2. [Epub ahead of print] Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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). pii: E2452. doi: 10.3390/cancers12092452. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of peritoneal seeding	involvement of peritoneal cavity with metastatic gastric cancer.	February 25th and December 25th 2020
Secondary	presence of peri-gastric lymph node involvement	involvement of peri-gastric lymph node with metastatic gastric cancer	February 25th and December 25th 2020