Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Background: Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. Methods: A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. Conclusion A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Purpose: Anal wounds following hemorrhoidectomy can lead to severe pain and postoperative bleeding, impacting patient recovery and quality of life. Hyaluronic acid (HA) stimulates tissue regeneration and wound healing by accelerating cell migration and proliferation. This study aimed to investigate the differences in wound healing rate and completeness of recovery of perianal wounds topically treated with HA-soaked cotton in a murine model. Methods: Forty-eight 8-week-old Sprague-Dawley rats with perianal wounds created using a biopsy punch were divided into 2 groups: simple dressing with gauze (control) and topical HA-soaked cotton. A single application of HA-soaked cotton was administered after surgery. Wound healing rate and completeness of recovery were evaluated by measuring the healed area and conducting histological analyses. Results: The HA-cotton group exhibited a shorter complete wound healing duration compared to the control group (13.9 days vs. 16.4 days, P = 0.031). Differences in wound healing area between the 2 groups were greatest on postoperative day 2 (51.6% vs. 28.8%, P < 0.001). The HA-cotton group exhibited fewer cases of granulation tissue (2 vs. 5) or redness (0 vs.3) upon complete wound healing. Histologically, the HA-cotton group showed accelerated reepithelialization, rapid shift to lymphocyte-dominant inflammation, enhanced fibroblast proliferation, and increased collagen deposition compared to the control group. Conclusion Herein, topical application of HA-soaked cotton on perianal wounds in rats resulted in accelerated wound healing, particularly in the initial stages, and improved completeness of recovery, underscoring the potential of the topical application of HA-soaked cotton on hemorrhoidectomy wounds in human patients to improve wound healing.

Purpose: The benefit of adjuvant chemotherapy for stage II colon cancer has not been clearly demonstrated even in cases with high-risk factors. This study aimed to compare the effectiveness of oral fluoropyrimidine monotherapy as adjuvant chemotherapy with that of intravenous fluoropyrimidine-based chemotherapy for high-risk stage II colon cancer. Methods: This single-institution, retrospective study included patients who underwent curative resection for high-risk stage II colon cancer between 2003 and 2014. Patients were classified into 3 postoperative treatment groups: observation, oral fluoropyrimidine monotherapy group (OG), or intravenous fluoropyrimidine-based chemotherapy group (IVG). Results: We identified 356 patients, including 87 (24.4%) in the observation group, 172 (48.3%) in the OG, and 97 (27.2%) in the IVG. Patients in the OG were older (63.8 ± 10.7 vs. 56.5 ± 10.8, P < 0.001) and had a lower number of T4 lesions (12.8% vs. 35.1%, P < 0.001) than those in the IVG. Regarding survival outcomes, the 5-year overall and disease-free survival rates were not different between the OG and IVG (91.2% vs. 92.6% [P = 0.090] and 85.1% vs. 81.9% [P = 0.535], respectively). In multivariate analysis, age over 70 years and no adjuvant chemotherapy were associated with poor overall survival and disease-free survival. Fewer chemotherapy-related adverse events of grade ≥3 were observed in the OG than in the IVG (12.2% vs. 34.0%, P < 0.001). Conclusion In high-risk stage II colon cancer, adjuvant oral fluoropyrimidine monotherapy can be an effective and convenient alternative to intravenous fluoropyrimidine-based chemotherapy as it has comparable oncological outcomes and reduced chemotherapy-related complications.

Purpose: Multidisciplinary care has become a cornerstone of colorectal cancer management. To evaluate the clinical efficacy of a geriatric multidisciplinary oncology clinic (GMOC), we analyzed the surgical treatment decision-making process and outcomes. Methods: This retrospective single-center study reviewed the data of patients aged ≥65 years who participated in the GMOC at a tertiary referral hospital between 2015 and 2021. The clinical adherence rate, comprehensive geriatric assessment, and a multidimensional frailty score (MFS) were obtained. The groups that were recommended and not recommended for surgery were compared, analyzing the factors impacting the decision and 1-year survival outcomes. Furthermore, the postoperative complications of patients who underwent surgery were evaluated. Results: A total of 165 patients visited the GMOC, and 74 had colorectal cancer (mean age, 85.5 years [range, 81.2–89.0 years]). Among patients with systemic disease (n = 31), 7 were recommended for surgery, and 5 underwent surgery. Among patients with locoregional disease (n = 43), 18 were recommended for surgery, and 12 underwent surgery. Patients recommended and not recommended for surgery had significantly different activities of daily living (ADL) (P = 0.024), instrumental ADL (P = 0.001), Mini-Mental State Examination (P = 0.014), delirium risk (P = 0.039), and MFS (P = 0.001). There was no difference in the 1-year overall survival between the 2 groups (P = 0.980). Of the 17 patients who underwent surgery, the median (interquartile range) of operation time was 165.0 minutes (120.0–270.0 minutes); hospital stay, 7.0 days (6.0–8.0 days); and 3 patients had wound complications. Conclusion Proper counseling of patients through the GMOC could lead to appropriate management and favorable outcomes.

Purpose: It is important to discover predictive factors that can identify rectal cancer patients who will respond well to neoadjuvant concurrent chemoradiotherapy (CCRT) to develop management strategies, preserve sphincter and avoid overtreatment. This study explored clinical factors that would predict the adequacy of nonradical management after CCRT in patients with middle or low rectal cancer. Methods: We retrospectively evaluated 447 patients with middle or low rectal cancer who were treated with curative surgery after neoadjuvant CCRT between January 2010 and December 2019. The good response group comprised patients with stages ypT0–1N0 on resection after CCRT; the remaining patients were included in the poor response group. Results: Of 447 patients (mean age, 60.37 ± 11.85 years), 108 (24.2%) had ypT0–1N0 (71.3% with ypT0N0, 4.6% with ypTisN0, and 24.1% with ypT1N0). Overall, 19 patients with cT1–2 (50.0% vs. 21.8% with cT3–4, P < 0.001), 22 with well-differentiated tumors (51.2% vs. 21.3% with moderately/poorly differentiated tumors, P < 0.001), 16 with fungating tumors (47.1% vs.22.3% with other types, P = 0.001), and 66 with anterior/posterior circumference direction (28.9% vs. 19.2% with lateral/ encircling direction, P = 0.016) had stage ypT0–1N0. On multivariable analysis, cT1–2 (P = 0.021) and well-differentiated tumor (P = 0.001) were independent predictors of ypT0–1N0. Fungating tumors were not significantly associated with ypT0– 1N0 (P = 0.054). Conclusion Stage cT1–2 and well differentiation are predictors of ypT0–1N0, while fungating tumors could be considered clinically meaningful, possibly identifying candidates for nonradical treatment post-CCRT.

Purpose: This study aimed to evaluate the safety and feasibility of single-port laparoscopic surgery (SLS) for appendiceal mucinous neoplasm (AMN) when compared with conventional laparoscopic surgery (CLS). Methods: This retrospective study enrolled patients who underwent surgery for AMN between July 2014 and June 2020 at Seoul National University Bundang Hospital. Patient demographics, surgical data, pathology, hospital stay, postoperative morbidity, and follow-up data were extracted from electronic records for analysis. Results: We enrolled 18 patients who underwent SLS and 22 who underwent CLS. The SLS group included patients who underwent partial cecectomy (14 patients), ileocecectomy (3 patients), and right hemicolectomy (1 patient). The CLS group included patients who underwent appendectomy (4 patients), partial cecectomy (11 patients), ileocecectomy (5 patients), and right hemicolectomy (2 patients). Operation type was not significantly different between groups (P = 0.213). No patient required open surgery in the SLS group in contrast to the CLS group (13.6%; P = 0.238). The operative time tended to be shorter in the SLS group than the CLS group (median [interquartile range]: 52.5 minutes [40–65.2 minutes] and 60 minutes [40–120 minutes], respectively; P = 0.251). Morbidity was 5.5% in the SLS group and 9.0% in the CLS group (P = 0.692). Surgical margins were clear in all cases. The median duration of postoperative hospital stay was 2.0 and 4.0 days in the SLS and CLS groups, respectively (P = 0.013). No recurrence occurred in either group during follow-up. Conclusion This study indicates that SLS is a safe and feasible surgical approach for AMN.