Abstract
Background/Aim: Despite the widespread use of laparoscopic surgery, intracorporeal anastomosis remains a complicated procedure that often prolongs the operation time. This study aimed to investigate the efficacy of a novel staple line reinforcement (SLR) during laparoscopic gastrectomy for gastric cancer. Patients and Methods: The study included 30 patients who underwent laparoscopic gastrectomy for gastric cancer at the Kochi Medical School between November 2021 and May 2022. A review of these patients was conducted, and perioperative outcomes were compared according to the use of SLR. Results: The reconstruction time using SLR was significantly shorter compared to when SLR was not used (20.5 min vs. 32.0 min, p=0.048). The incidence of hemostasis during anastomosis was significantly lower in the SLR group than in the non-SLR group (0 vs. 3 times, p=0.041). There were no significant differences in the operating time and estimated blood loss after surgery between the two groups. Furthermore, there were no significant differences in postoperative complications or nutritional status between the two groups. Conclusion: The usefulness of SLR in reducing the time for intracorporeal reconstruction and archiving the best interaction between device and tissue during laparoscopic gastrectomy for gastric cancer, was herein demonstrated.
Gastric cancer is a severe threat to health worldwide; it is the fifth most common cancer and the third leading cause of cancer-associated deaths globally, and the second most frequent cause of cancer-associated death in Japan (1). Laparoscopic surgery is a widely performed minimally invasive surgical procedure for the treatment of gastric cancer (2). Although instrument anastomosis using surgical stapling devices is the main method for digestive tract reconstruction during laparoscopic gastrectomy, advanced surgical techniques are required to perform intracorporeal anastomosis.
Various staple line reinforcement (SLR) techniques have been developed for clinical use to reduce the occurrence of incisional leakage (3, 4). Different techniques for SLR have been reported, which include oversewing the staple line, fibrin glue application, use of bioabsorbable buttressing material, and omental or jejunal wrapping (5). Recently, a novel SLR, which can be applied as a bioabsorbable material in a conventional linear stapler, was developed to reduce the incidence of early staple line complications. We performed intracorporeal gastrointestinal anastomosis using SLR for reconstruction during laparoscopic surgery for gastric cancer and discovered various advantages over the reconstruction using conventional linear stapler. This study analyzed retrospectively the intraoperative and postoperative results of intracorporeal anastomosis during laparoscopic gastrectomy for gastric cancer and compared the results between the SLR and non-SLR method.
Patients and Methods
Patients. This study was a retrospective review of 30 patients with gastric cancer who underwent laparoscopic gastrectomy between November 2021 and May 2022 at the Kochi Medical School Hospital, Japan. Clinical information, such as age at diagnosis, tumor stage, and postoperative outcomes, was considered. All clinicopathological data and staging were analyzed and determined according to the 7th International Union Against Cancer (UICC) TNM classification (6).
Staple line reinforcement. We used the ECHELON ENDOPATH™ Staple Line Reinforcement (ETHICON, Johnson & Johnson, Ltd., Cincinnati, OH, USA) to oversew the staple line, which was made from the bioabsorbable materials used in VICRYL® and PDS® sutures (ETHICON, Johnson & Johnson) (Figure 1). This applicator allows precise control during attachment and the buttress attachment material provides seamless tissue manipulation and release. The applicator reinforces the staple line by clamping and releasing to ensure accurate pre-applied self-adhesive buttress on the stapler anvil and cartridge.
Linear stapler equipped staple line reinforcement (SLR). The SLR was properly aligned and covered the reload and anvil (A, arrow). Using this instrument, the stapler line is covered with reinforcement (B).
The patient cohort was divided into two groups and comparisons were made between groups: the group using SLR (SLR) and the group without SLR (non-SLR). All surgeries were performed or supervised by experienced gastric surgeons with skilled qualifications.
Laparoscopic intracorporeal reconstruction using SLR. After laparoscopic distal gastrectomy with lymphadenectomy in accordance with the guidelines of the Japanese Gastric Cancer Association, we performed delta-shaped gastroduodenostomy for intracorporeal Billroth I (BI) reconstruction (7). Both the duodenum and stomach were transected using linear staplers, with SLR attached to the surface of the linear stapler. After making small holes on the greater curvature side of the cut end of both the stomach and duodenum (Figure 2A), both posterior walls of the remnant stomach and duodenum were anastomosed using a linear stapler without SLR (Figure 2B). The common entry hole was closed using a linear stapler after temporary closure with three stitches.
Laparoscopic gastroduodenostomy using staple line reinforcement (SLR). After transection of the duodenum using SLR, the cut-off end can be firmly grasped with laparoscopic forceps, and a small hole can be made on the greater curvature side of the duodenal cut end by aligning the direction of the duodenal stump and an ultrasonic coagulation cutting device (A). A linear stapler can be smoothly inserted into the remnant stomach and duodenum to obtain an accurate suture line for gastroduodenostomy by holding both cut ends of the SLR and pulling in the appropriate direction (B).
After laparoscopic total gastrectomy with lymphadenectomy, we performed a T-shaped esophagojejunostomy for intracorporeal Roux-en-Y (RY) reconstruction. The duodenum, esophagus, and jejunum, as the Roux limb, were also transected using linear staplers with SLR. Small holes were made on the right side of the esophageal stump and on the opposite side of the mesentery of the lift-up jejunal Roux limb after a side-to-side jejunojejunostomy (Figure 3A). Subsequently, esophagojejunal anastomosis was performed using a linear stapler without an SLR near the staple line of the esophageal stump. Finally, the entry hole and esophageal stump were simultaneously resected using a linear stapling device with SLR after temporary closure with three stitches (Figure 3B). The surgical procedures for both BI and RY reconstruction techniques following laparoscopic gastrectomy have been described in detail elsewhere (8-10).
Laparoscopic esophagojejunostomy using staple line reinforcement (SLR). To make a small hole, a nasogastric tube can lead to the right edge of the esophageal stump while controlling the cut-off end transected by a stapler with SLR to align the axis of the nasogastric tube and the esophagus (A). The common entry hole consisting of the esophagus and jejunum was closed using a linear stapler with an SLR (B).
The study was approved by the Institutional Review Board of the Kochi Medical School Hospital (approval number: 2022-60) and was conducted in accordance with the Helsinki Declaration and Japanese Good Clinical Practice guidelines. Informed consent was obtained from all participants.
Evaluated parameters. We reviewed each patient’s records and documented their baseline data, perioperative outcomes, surgical complications, and postoperative nutritional parameters. Postoperative complications were evaluated according to the Clavien–Dindo (CD) classification (11). Postoperative systemic inflammation and nutritional status, such as albumin, hemoglobin, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio (NLR), and prognostic nutrition index (PNI), were evaluated at 4 weeks after surgery. Body weight change was calculated as the rate of change between the preoperative parameters and those 4 weeks after surgery. The neutrophil count divided by the lymphocyte count was recorded as the NLR, and the PNI was calculated using the following formula: PNI=serum albumin level (g/l) + [5× total lymphocyte count (/l)].
Statistical analysis. We analyzed the differences between the mean values for the two groups of patients for significance using the Mann-Whitney U-test for continuous variables and Pearson’s chi-squared test for categorical variables. Statistical analyses were performed using SPSS version 22.0. A p-value <0.05 was considered statistically significant.
Results
Patient characteristics. Table I summarizes the clinical characteristics of patients who underwent intracorporeal anastomosis during laparoscopic surgery for gastric cancer. The cohort comprised 21 men and nine women, with a median age of 72 years (range=42-89 years). The disease stages were; stage I for 12 patients, stage II for seven patients, and stage III for 11 patients. Surgical treatment included laparoscopic distal gastrectomy in 19 patients and laparoscopic total gastrectomy in 11 patients. There were no significant differences in age, sex, stage, surgical procedure, or comorbidities between groups with and without SLR.
Clinical characteristics of patients who underwent laparoscopic gastrectomy depending on use of staple line reinforcement.
Perioperative results. The perioperative results of patients who underwent laparoscopic gastrectomy depending on the use of SLR are shown in Table II. The reconstruction time in the SLR group was significantly shorter than that in the non-SLR group (20.5 min vs. 32.0 min, p=0.048). The incidence of hemostasis for incisional line bleeding during anastomosis was significantly smaller in the SLR group than in the non-SLR group (0 vs. 3 times, p=0.041). There were no significant differences in the operative time and estimated blood loss during surgery between the SLR and non-SLR groups. Postoperative pneumonia occurred in one patient in the SLR group and postoperative ileus occurred in one patient in the non-SLR group. Furthermore, there were no significant differences in postoperative complications according to the CD classification between the two groups.
Perioperative results of patients who underwent laparoscopic gastrectomy depending on usage of staple line reinforcement.
Changes of nutritional parameters. Data on the nutritional status of patients who underwent laparoscopic gastrectomy depending on the use of staple line reinforcement is shown in Table III. There were no significant differences in body weight change, albumin, hemoglobin, CRP, NLR, or PNI between the two groups.
Nutritional status of patients who underwent laparoscopic gastrectomy depending on usage of staple line reinforcement.
Discussion
The results of the present study showed that the time for reconstruction using SLR was significantly shorter than that of non-SLR techniques. This is the first report to assess the clinical efficacy of SLR, which can reduce the time required for reconstruction after gastrectomy. Our results suggest the feasibility and effectiveness of SLR during laparoscopic gastrectomy.
Several factors associated with reduction time for reconstruction were considered. First, by attaching the SLR to conventional stapling devices, the tissue is crimped on the surface with a bioabsorbable reinforcing material, resulting in a high hemostatic effect on the dissected valgus deformity. In the present study, the incidence of hemostasis during anastomosis was significantly lower in the SLR group than that in the non-SLR group. In procedures using a conventional stapling device, it is often necessary to carefully stop bleeding from the stump of the intestine or stomach using soft coagulation; however, minor bleeding had almost completely disappeared when SLR was used.
Another useful point of using SLR is good handling of the stump of the intestine or stomach, which might contribute to the reduction in reconstruction time. Since the bioabsorbable material of the SLR continuously reinforces the staples pushed into the tissue, the cutoff end can be firmly grasped with laparoscopic forceps. To perform a gastroduodenostomy or esophagojejunostomy, the stump of each organ must be pulled in the appropriate direction and angled to obtain an accurate suture line. By grasping the staple surface reinforced by continuous SLR, the organs can be safely moved without damaging the tissue. The high hemostatic effect of SLR and the advantage of being able to grip the tissue gently may contribute to shortening the operation time.
In addition, SLR is used for duodenal transection during RY reconstruction; a flexible reinforcing material can effectively close the lumen without burying the stump, making it possible to close the duodenum safely and accurately. In a retrospective study of 965 patients with gastric cancer who underwent laparoscopic distal or total gastrectomy with RY reconstruction, it was reported that duodenal stump leakage occurred less frequently in the reinforcement than in the non-reinforcement group (0.67% vs. 5.71%, p<0.001) (11). On the other hand, the operative duration was extended by 33 min for laparoscopic distal gastrectomy and by 40 min for laparoscopic total gastrectomy in the reinforcement group compared to the non-reinforcement group (12). SLR made from bioabsorbable materials could contribute to a reduction in duodenal stump leakage without prolonging the duration of surgery.
In the present study, no significant differences were observed in postoperative complications, including postoperative bleeding and anastomotic leakage. Previous studies have demonstrated that staple line treatment techniques, such as oversewing or SLR via roofing or buttressing, have been implemented to mitigate the risk of staple line complications (4, 13, 14). Ojima et al. reported that no anastomosis-related complications, such as anastomotic leakage, anastomotic stricture, and postoperative gastrointestinal bleeding were found in 24 consecutive patients with gastric cancer who underwent a reinforced stapling technique for reconstruction after laparoscopic distal gastrectomy (15). Further studies with larger sample sizes are needed to confirm the positive surgical outcomes in patients who received biomaterial reinforcement during laparoscopic gastrectomy for gastric cancer.
In a meta-analysis of randomized controlled trials for bariatric surgery, such as laparoscopic sleeve gastrectomy, suture oversewing seemed to be associated with a reduced risk of postoperative bleeding, staple line leak, and overall complications; however, no differences were found compared to bioabsorbable materials in the staple line (4). The procedure for sleeve gastrectomy involves a mostly vertical stapled transection of the stomach and removal of the gastric fundus to create a tubular alimentary channel along the lesser curvature; reconstruction was not included. Elkomos et al. reported that the incidence of clinically significant postoperative pancreatic fistula was significantly lower in distal pancreatectomy (DP) with reinforced staplers than in DP with bare staplers (16). Findings from previous studies and the results of the present study suggest that the newly developed SLR made from bioabsorbable materials could reduce the risk of postoperative complications in comparison to no reinforcement.
Previous benchtop burst pressure tests demonstrated that reinforced staple lines significantly improved staple line strength, as evidenced by a burst pressure increase of 109% compared to no SLR (17). In addition, it has been reported that the new SLR is similar in hemostasis to standard products and superior to stapling without the use of buttress (18). This newly developed SLR requires an adhesive to be applied to the stapler cartridge and anvil. Therefore, we have to consider the thickness of these materials in addition to the original stapler height affecting the tissue integrity of the target organs. Furthermore, the buttress material can slip, twist, slide or bunch on the stapler anvil and cartridge during stapler positioning and firing in clinical use. The surgeon must carefully watch the placement to ensure that the buttress moves unintentionally, and the buttress is fully captured by all individual staples (18).
This study has several limitations. First, it was conducted in a single institution with a relatively small number of subjects; thus, it could be affected by patient selection bias. Second, it was a retrospective single-arm observational study, and the fact that this was not a randomized controlled study could have led to selection bias. Therefore, the results of the study must be interpreted cautiously. A simple and reliable device for laparoscopic surgery is a promising application. Further studies with adequate statistical power and a larger number of patients are required to confirm the reliability and efficacy of this novel SLR for intracorporeal reconstruction during laparoscopic gastric cancer surgery.
In conclusion, the procedure using a stapler equipped with an SLR can reduce the time for reconstruction in laparoscopic gastrectomy for gastric cancer. During the transection of organs and reconstruction in laparoscopic gastrectomy for gastric cancer, the surgical procedure can be performed safely and accurately using SLR together with staplers. Further studies are required to confirm, update, and commercialize the product, taking the required costs into account, to confirm the universal utility of this device.
Acknowledgements
We acknowledge the contributions of our colleagues from the Department of Surgery, Kochi Medical School.
Footnotes
Authors’ Contributions
T.N., M.U., K.Y., M.M, S.U., H.M., H.K., M.K., K.H., and S.S. managed the patient. T.N. wrote the article and provided the original pictures. All the other Authors reviewed the article, and all Authors approved the final content of the article.
Conflicts of Interest
The Authors have no conflicts of interest or financial ties to disclose.
- Received October 26, 2022.
- Revision received November 9, 2022.
- Accepted November 14, 2022.
- Copyright © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.
