Retrospective Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Jan 27, 2024; 16(1): 95-102
Published online Jan 27, 2024. doi: 10.4240/wjgs.v16.i1.95
Post-operative morbidity after neoadjuvant chemotherapy and resection for gallbladder cancer: A national surgical quality improvement program analysis
Minha Kim, Stephanie Stroever, Krist Aploks, Alexander Ostapenko, Xiang Da Dong, Ramanathan Seshadri
Minha Kim, Krist Aploks, Alexander Ostapenko, Department of General Surgery, Danbury Hospital, Danbury, CT 06810, United States
Stephanie Stroever, Department of Research and Innovation, Nuvance Health, Danbury, CT 06810, United States
Xiang Da Dong, Ramanathan Seshadri, Division of Surgical Oncology/Hepato-Pancreato-Biliary Surgery, Danbury Hospital, Danbury, CT 06810, United States
Author contributions: Kim, M, Aploks K, Ostapenko A, Dong X, and Seshadri R contributed to the conceptualization of the project; Kim M, Stroever S, Aploks K, Ostapenko A, Dong X, and Seshadri R contributed to the methodology and validation of the data; Stroever S conducted the formal statistical analyses; Kim, M, Aploks K, Ostapenko A prepared the original manuscript; Kim, M, Aploks K, Ostapenko A, Dong X, and Seshadri R contributed to the final draft revision and edition; Dong X, and Seshadri R supervised the project.
Institutional review board statement: Ethical review and approval was not required for this study since the data used was de-identified and obtained from a participant use file.
Informed consent statement: This study is a retrospective review that utilized only de-identified patient data from the American College of Surgeons National Surgical Quality Improvement Program.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
Data sharing statement: Data was obtained with the permission from the American College of Surgeons NSQIP database. NSQIP data can be obtained at https://www.facs.org/quality-programs/data-and-registries/acs-nsqip/.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Ramanathan Seshadri, MD, Surgeon, Division of Surgical Oncology/Hepato-Pancreato-Biliary Surgery, Danbury Hospital, 95 Locus Avenue, Danbury, CT 06810, United States. ramanathan.seshadri@nuvancehealth.org
Received: September 23, 2023
Peer-review started: September 23, 2023
First decision: November 9, 2023
Revised: November 27, 2023
Accepted: December 18, 2023
Article in press: December 18, 2023
Published online: January 27, 2024
Abstract
BACKGROUND

Gallbladder cancer is the most common malignancy of the biliary tract. Neoadjuvant chemotherapy (NACT) has improved overall survival by enabling R0 resection. Currently, there is no consensus of guidelines for neoadjuvant therapy in gallbladder cancer. As investigations continue to analyze the regimen and benefit of NACT for ongoing care of gallbladder cancer patients, we examined American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database to determine if there was higher morbidity among the neoadjuvant group within the 30-day post-operative period. We hypothesized patients who underwent NACT were more likely to have higher post-operative morbidity.

AIM

To investigate the 30-day post-operative morbidity outcomes between patients who received NACT and underwent surgery and patients who only had surgery.

METHODS

A retrospective analysis of the targeted hepatectomy NSQIP data between 2015 and 2019 was performed to determine if NACT in gallbladder cancer increased the risk for post-operative morbidity (bile leak, infection rate, rate of converting to open surgery, etc.) compared to the group who only had surgery. To calculate the odds ratio for the primary and secondary outcomes, a crude logistic regression was performed.

RESULTS

Of the 452 patients, 52 patients received NACT prior to surgery. There were no statistically significant differences in the odds of morbidity between the two groups, including bile leak [odds ratio (OR), 0.69; 95% confidence interval (95%CI): 0.16-2.10; P = 0.55], superficial wound infection (OR, 0.58; 95%CI: 0.03-3.02; P = 0.61), and organ space wound infection (OR, 0.63; 95%CI: 0.18-1.63; P = 0.61).

CONCLUSION

There was no significant difference in the risk of 30-day post-operative morbidity between the NACT and surgery group and the surgery only group.

Keywords: Gallbladder cancer, Neoadjuvant chemotherapy, Radical cholecystectomy, National Surgery Quality Improvement Program, Postoperative outcome

Core Tip: In this retrospective study, we utilized the National Surgery Quality Improvement Program database to assess the post-operative morbidity of neoadjuvant chemotherapy (NACT) for gallbladder cancer. While the role of NACT for gallbladder cancer is being investigated, surgeons should be mindful of the potential complications patients receiving NACT may be at risk for post-operatively. Our study revealed that NACT was not associated with increased post-operative morbidity, such as bile leaks or wound infections. Although there were no increased complications, NACT should be carefully evaluated for each individual patient due to the inherent side effects of chemotherapy.