Innovation in laparoscopic gangrenous cholecystectomies

Introduction

Since its introduction in 1998, the laparoscopic technique for cholecystectomies has become the standard of care.1 Often, the severity of cholecystitis does not correlate with surgical difficulty. However, among cholecystectomies, the most difficult procedure is to treat gangrenous cholecystitis, with a high incidence of iatrogenic complications (i.e. such as conversion to open cholecystectomies, subtotal cholecystectomies, and cholecystostomy, as outlined by Tokyo guidelines of 2018.2 Currently, standard laparoscopic cholecystectomies for gangrenous gallbladders (GB) involve frank dissection. Blunt dissection helps remove necrotic tissue and purulent material that surrounds the GB, ultimately clearing the visual field and allowing removal of the inflamed GB (Figure 1). However, blunt dissection is technically challenging as it is performed in hemorrhagic and inflamed fields interspersed with dense adhesions and can lead to complications such as bleeding and damage to nearby structures.1 These complications are often associated with increased mortality, morbidity, time spent operating and length of hospital stay, leading to financial burdens due to malpractice ($250,000 to 1, $2 million) and health insurance expenses related to the management of complications ($100,000 to $1.5 million). ).3

Figure 1 Review of cholecystectomy techniques. (A) Non gangrenous gallbladder. Illustration of the critical safety view, with the cystic artery and duct serving as anatomical landmarks. (B) Gangrenous gallbladder. Representation of an occulted operating field and critical vision of safety due to an inflammatory and hemorrhagic landscape. (VS) Cholecystectomy of a gangrenous gallbladder with blunt dissection. Blunt dissection of a gangrenous gallbladder, with an obscured critical view of safety, using Maryland laparoscopic forceps for dissection. The digital clock details the average running time using blunt dissection. (D) Cholecystectomy of a gangrenous gallbladder by hydrodissection. Cholecystectomy performed with hydrodissection, where saline solution is used to clean debris and reveal the critical view of safety. The digital clock indicates a decrease in running time for hydrodissection compared to blunt dissection.

An innovative use of the hydrodissection technique

Hydrodissection (HD), a technique commonly used in cataract surgery, spine surgery, median nerve entrapment cases, and liver resection, can serve as a powerful complement to traditional laparoscopy and reduce the risk associated complications. Although HD has not shown benefit in routine simple cholecystectomies,4.5 our results in a retrospective research study demonstrated that HD is effective for the specific case of cholecystectomies treating gangrenous GB.

HD involves the use of a modified, FDA-cleared laparoscopic irrigation tool that releases jets of normal saline at a predetermined pressure ranging from 14.5 to 1160 psi.6 These pressures are strong enough to remove necrotic and inflamed tissue without disrupting the collagen matrix, thus allowing dissection of the cystic duct, cystic artery and WBC from surrounding organs including liver, omentum, stomach and intestine (Figure 1).

For this procedure, the Stryker irrigation system was incorporated into standard laparoscopic surgery to remove the GB, by dissecting the proximal third of the GB and Calot’s triangle from the liver and adjacent structures. In the irrigation system, the terminal tip of the catheter was occluded, thus generating higher pressures (150 to 200 psi) of jet through the unoccluded side holes.

HD is able to clear the highly vascularized and purulent surgical field, thereby improving visualization of the WBC. This helps expose the critical view of safety that helps prevent complications such as bile duct injury and deep infection, and improves surgical measures (i.e. conversion to open procedure, time operation, anesthesia time, hospital stay and the number of complications associated with long surgical procedures) independently of body mass index and other comorbidities.

Evidence supporting the use of hydrodissection

In our submitted data of 386 patients collected between 2018 and 2020, 24 patients were reported to have gangrenous GB during the procedure. The age and sex of the patients were matched to create a control group. Using the Mann-Whitney U test and the chi-square test, we observed a statistically significant reduction in operative time and length of stay (LOS) with HD compared to the standard technique. Other parameters such as conversion to open procedures and readmissions within 30 days tended towards statistical significance. Two patients in the comparison group required conversion to open procedure and no patient in the study group required conversion to open procedure. Incidentally, no patient required cholecystectomies or subtotal cholecystostomies.

Discussion

In 2002, a pig study showed the feasibility of the HD technique, but a subsequent human study failed to show its effectiveness in routine simple cholecystectomy.4.5 The HD group had cleaner surgical fields resulting in faster and cleaner dissections.4 However, common simple cholecystectomy involved healthy tissue, which is difficult to separate in HD, therefore the study did not show a statistically significant decrease in operative time. This highlights that HD benefits a niche group of patients with gangrenous GB, because HD more easily dissects the weakened and inflamed tissue of gangrenous GB than the strong connective tissue of non-gangrenous GB.

However, other studies have shown the potential of using HD for laparoscopic cholecystectomies. In a study using HD during laparoscopic cholecystectomies, 55 patients were separated into different groups according to the level of surgical difficulty determined by the Cuschieri scale.seven The results demonstrated better visualization of the anatomy of all patients; however, some patients still required sharp dissection to complete the procedure.seven Another study of 133 patients using HD for laparoscopic cholecystectomies investigated which procedure to use during prograde and retrograde dissection to help with cirrhosis of the liver.8 This study reported decreased blood loss, decreased incidence of GB lesions, and faster dissection times.8 These studies confirm the effectiveness of HD for treating laparoscopic cholecystectomies and underscore the need for further modification of the technology. This study focuses on the application of HD for gangrenous GB which constitutes the most complicated GB surgery and 10% to 25% of all GB surgeries. This is a new indication of HD that is not discussed or studied in previous literature.

Impact on clinical care

Given the frequency of bile duct lesions, estimated at 2500 patients per year in cholecystectomies, the risk of complications such as anastomotic strictures (10% to 20%), increased bleeding (3.64%) and cholangitis is important.3 Vascular lesions of the hepatic arteries and portal vein, surrounding inflammation and the need to convert to open surgery (3.91%) further complicate patient management.1.3 However, with the precise delivery of normal saline to the gangrenous area, HD can reduce the risk of such complications and improve patient care.

Hydrodissection landscape in the future

To further support our preliminary results, we are currently recruiting patients for a multi-institutional study of 1500-2000 patients.

With respect to scaling up the technique, creating standard and case-specific guidelines for optimal parameters (eg, angle, speed, and force) for normal saline administration can be a laborious process. Additionally, the cost of HD equipment, the lack of reimbursement, and the training of multiple providers may limit widespread adoption of the HD technique.

In addition, in disadvantaged areas, the acquisition of HD equipment may be delayed. However, with the common application of the HD technique in ophthalmology (eg, cataract surgery) and physical medicine, the incorporation of HD into laparoscopic procedures is a feasible initiative. Additionally, with a more user-friendly device on the way, pending FDA clearance, HD adoption will be enhanced.

Given the poor results and the complexity of gangrenous GB surgeries, HD is on the way to becoming the basic technique in cholecystectomies treating gangrenous GB.

Declaration of informed consent

Anonymized data was used; no consent was required.

Funding

This study has no associated funding.

Disclosure

Shahini Ananth and Kayla K Umemoto are the co-first authors of this study. Dr. Dinesh Vyas reveals that he is CEO and President of MV Surgical LLC, MV Surgical Medical Technologies Inc., MV Surgical Medical Devices Inc. and Stocks in BlackSwan Inc. Additionally, he is an editor for International Journal of General Medicine. The authors report no other conflicts of interest in this work.

References

1. Radunovic M, Lazovic R, Popovic N, et al. Complications of laparoscopic cholecystectomy: our experience from a retrospective analysis. Open Access Maced J Med Sci. 2016;4(4):641–646. doi:10.3889/oamjms.2016.128

2. Wakabayashi G, Iwashita Y, Hibi T, et al. Tokyo Guidelines 2018: Surgical management of acute cholecystitis: safe steps in laparoscopic cholecystectomy for acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018;25(1):73–86. PMID: 29095575. doi: 10.1002/jhbp.517

3. Schreuder AM, Busch OR, Besselink MG, et al. Long-term impact of iatrogenic lesions of the bile ducts. Dig Surg. 2020;37(1):10–21. doi:10.1159/000496432

4. Shekarriz H, Shekarriz B, Upadhyay J, et al. Hydro-Jet assisted laparoscopic cholecystectomy: first experience on a porcine model. J Soc Laparoendosc Surg. 2002;6(1):53–58.

5. Shekarriz H, Shekarriz B, Kujath P, et al. Hydro-Jet assisted laparoscopic cholecystectomy: a prospective randomized clinical study. Operation. 2003;133(6):635–640. doi:10.1067/msy.2003.155

6. Melkerson MN. ERBE USA has incorporated the abbreviation 510(k) – erbe erbejet. abstract 510K; 2007. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf7/K072404.pdf. Accessed September 222022.

7. Lubna H, Masoom MR. Hydro-dissection – A simple solution in difficult laparoscopic cholecystectomy. Mymensingh Med J. 2015;24(3):592–595. PMID: 26329960.

8. Naudé GP, Morris E, Bongard FS. Laparoscopic cholecystectomy facilitated by hydrodissection. J Laparoendosc Adv Surg Tech A. 1998;8(4):215–218. PMID: 9755913. doi: 10.1089/lap.1998.8.215

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