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Hyperthermic intraperitoneal chemotherapy plus SOX chemotherapy versus SOX chemotherapy alone in patients with gastric cancer and peritoneal metastasis: a phase II randomized clinical trial

J Gastrointest Oncol. 2025 Feb 28;16(1):17-26. doi: 10.21037/jgo-24-807. Epub 2025 Jan 9.

ABSTRACT

BACKGROUND: The prognosis of patients with gastric cancer with peritoneal metastasis (GCPM) is exceedingly poor. This study evaluated the efficacy and safety of hyperthermic intraperitoneal chemotherapy (HIPEC) with paclitaxel combined with S-1 and oxaliplatin (SOX) in the treatment of GCPM.

METHODS: Patients with pathologically confirmed primary gastric adenocarcinoma and laparoscopy-confirmed peritoneal metastasis were enrolled and randomized to receive either HIPEC plus SOX (HIPEC group) or SOX alone (SOX group). The primary endpoint was progression-free survival (PFS), and the secondary endpoints were 1-year survival rate, overall survival (OS), and safety.

RESULTS: Among the included patients, 30 were assigned to the HIPEC group and 29 to the SOX group. Compared to the HIPEC group, the SOX group had a significantly higher median PFS (SOX: median 8.5 months, IQR, 3.8-21.8 months; HIPEC: median 6.1 months, IQR, 3.3-10.8 months; P=0.004) and OS (SOX: median 13.0 months, IQR, 6.3-16.6 months; HIPEC: median 10.0 months, IQR, 5.2-24.0 months; P=0.02). The 1-year survival rate was 50.0% in the SOX group and 37.9% in HIPEC group, but the difference was not statistically significant. No serious adverse events related to the protocol treatment occurred in any patients.

CONCLUSIONS: This trial failed to show the superiority of HIPEC with SOX over SOX alone. Further research into this regimen is needed.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03604614.

PMID:40115934 | PMC:PMC11921333 | DOI:10.21037/jgo-24-807

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Effect of a Nursing intervention on the uncertainty of family members in Intensive Care

Rev Cuid. 2024 May 27;15(1):e3220. doi: 10.15649/cuidarte.3220. eCollection 2024 Jan-Apr.

ABSTRACT

INTRODUCTION: Family members of patients admitted to an Intensive Care Unit present high uncertainty level due to not knowing what is happening and to not having clear details about the related events; therefore, interventions are required to allow modulating those levels.

OBJECTIVE: To evaluate the effect of an educational Nursing intervention compared to conventional care on the uncertainty of family members of patients hospitalized in an ICU.

MATERIALS AND METHODS: An experimental study with a sample comprised by 132 relatives of patients admitted to an ICU, randomly distributed in four Solomon groups (33 in each group). The Nursing intervention based on the concepts of the Uncertainty in Illness Theory was applied to both experimental groups and devised under the Whittemore and Grey parameters with three moments: assessment; education about the relative’s hospitalization in the ICU; and accompaniment. This was done with pre-assessments for two groups and post-assessments for the four groups, using the PPUS-FM Uncertainty Scale. The data were analyzed by means of descriptive statistics and respective non-parametric analyses. The study took into account the ethical principles in research.

RESULTS: The family members in the experimental groups presented a lower final uncertainty level when compared to the control groups, with a difference of 73.04 points and a p-value of 0.001.

DISCUSSION: Standardized interventions and under a theoretical model allow reducing uncertainty in relatives of patients in ICUs.

CONCLUSIONS: The Nursing intervention based on the Uncertainty theory allows reducing uncertainty in relatives of patients hospitalized in an Intensive Care Unit.

PMID:40115899 | PMC:PMC11560101 | DOI:10.15649/cuidarte.3220

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Retropharyngeal lymph node metastases from head and neck cancer removed by transoral robotic surgery

Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2025 Mar 20;60:292-299. doi: 10.3760/cma.j.cn115330-20240812-00471. Online ahead of print.

ABSTRACT

Objective: To evaluate the safety, and feasibility of transoral robot-assisted retropharyngeal lymph node (RPLN) dissection. Methods: Clinical data of head and neck cancer patients who underwent transoral robot-assisted RPLN dissection from December 2017 to March 2024 at the Department of Otorhinolaryngology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, and Sun Yat-sen University Cancer Centre were retrospectively analyzed. A total of 35 patients(22 males, 13 females, aged 47.4±13.4 years old) with retropharyngeal lymph node metastases from head and neck cancer, including 20 cases of nasopharyngeal cancer, 9 cases of thyroid cancer, 2 cases of salivary adenocarcinoma, 2 cases of tonsil cancer and 2 cases of hypopharyngeal cancer. Operation time, intraoperative bleeding and complications, postoperative nasogastric tube retention time, hospital stay and complications were evaluated. Statistical analysis was performed using SPSS 22.0 software. Results: All patients successfully received transoral robot-assisted RPLN dissection without intermediate open surgery, with removals of 2 (1, 3) RPLNs. The total operation time was 130 (102, 210) minutes. The intraoperative bleeding was 50 (20, 100) ml, and there was no major bleeding or organ damage during the operation. Prophylactic tracheotomy was performed in 8 cases, and postoperatively nasogastric tubes were left in 22 patients, with retention time of 10.5 (7.5, 14.0) days. Postoperative hospital stay was 5 (4, 9) days. Postoperative complications included incision dehiscence in 4 cases and dysphagia in 4 cases. The median postoperative follow-up was 23.4 months, with progression or recurrence in 5 patients, including regional recurrence in 3 patients, lung metastasis in 1 patient, and bone metastasis in 1 patient. The 2-year regional failure-free survival and disease-free survival rates were 91.43% and 85.71%, respectively. Conclusion: Transoral robot-assisted RPLN dissection is a safe and feasible surgical method with less trauma, fewer complications, and higher safety. Patients need to be carefully selected at the initial stage of application.

PMID:40113568 | DOI:10.3760/cma.j.cn115330-20240812-00471

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Multi-center retrospective study of transoral robotic surgery for supraglottic laryngeal cancer

Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2025 Mar 20;60:266-271. doi: 10.3760/cma.j.cn115330-20240807-00466. Online ahead of print.

ABSTRACT

Objective: To explore the safety, effectiveness, and short-term outcomes of transoral robotic surgery (TORS) for supraglottic laryngeal cancer. Methods: A retrospective analysis was conducted on patients with supraglottic laryngeal cancer who underwent TORS at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Eye Ear Nose and Throat Hospital of Fudan University, and the First Affiliated Hospital of China Medical University between January 2018 and April 2024. Data on operative time, intraoperative blood loss, postoperative hospital stay, perioperative tracheostomy, nasogastric feeding, complications, and short-term follow-up were analyzed. Statistical analysis was performed using Python. Results: A total of 27 patients with supraglottic laryngeal cancer were included from the four centers, including 24 males and 3 females, with a median age of 66 (65, 68) years [M(Q1, Q3), same below]. There were 26 cases of squamous cell carcinoma and 1 case of adenoid cystic carcinoma.The TNM staging included T1 in 10 cases (37.04%), T2 in 13 cases (48.15%), and T3 in 4 cases (14.81%); N0 in 14 cases (51.85%), N1 in 7 cases (25.93%), and N2 in 6 cases (22.22%). The Da Vinci Si system was used in 23 cases, and the Da Vinci Xi in 4 cases. The robotic surgical time was 53 (30, 58) min. Concurrent neck dissection was performed in 25 cases, neoadjuvant therapy was given preoperatively in 8 cases (29.63%), and postoperative radiotherapy was administered in 13 cases (48.15%). Tracheostomy was performed in 11 cases (40.74%). Nasogastric tube placement was required in 23 cases (85.19%), with a median duration of 16 (12, 21) days. The postoperative hospital stay was 9.19±4.07 days. The median follow-up time was 12 (3, 30) months. Local recurrence occurred in 2 cases. The 3-year overall survival rate was 100%, and the 3-year disease-free survival rate was 94.1%. Conclusion: With appropriate patient selection, TORS for supraglottic laryngeal cancer demonstrates satisfactory short-term outcomes, offering advantages in safety, efficacy, and minimal invasiveness. It can be considered a new treatment option for this condition.

PMID:40113567 | DOI:10.3760/cma.j.cn115330-20240807-00466

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Multicenter study on the efficacy of transoral robotic surgery for malignant tongue base tumors

Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2025 Mar 20;60:278-284. doi: 10.3760/cma.j.cn115330-20240806-00464. Online ahead of print.

ABSTRACT

Objective: To evaluate the clinical efficacy of transoral robotic surgery (TORS) in the treatment of malignant tongue base tumors. Methods: A multicenter study was conducted to collect and analyze the clinical data of patients with malignant tongue base tumors who underwent TORS between January 2017 and January 2023 at five otolaryngology-head and neck surgery centers in China, including Eye Ear Nose and Throat Hospital of Fudan University, Sun Yat-sen University Cancer Center, Tongji Hospital of Huazhong University of Science and Technology, Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and the First Affiliated Hospital of China Medical University. Among the patients, 38 were males and 11 were females, with a mean age of 59.0±8.8 years. Baseline characteristics, complications, and follow-up data were compared between groups. Independent sample t-tests or Mann-Whitney U tests were used for comparisons of continuous variables; chi-square tests or Fisher’s exact tests were applied for categorical variables. Survival analysis was performed using the Kaplan-Meier method to calculate overall survival and disease-free survival, with differences between groups compared using the log-rank test. Results: Among the 49 patients, 41 (83.7%) were diagnosed with squamous cell carcinoma (SCC), with a p16 positivity rate of 51.2% (21/41). There were no statistically significant differences between the p16-positive group (n=21) and the p16-negative group (n=20) in age, sex, or postoperative bleeding (all P>0.05). However, there was a significant difference in TNM stage between the two groups (χ2=14.556, P=0.020), with the p16-positive group predominantly in stage I (66.7%) and the p16-negative group primarily in stages Ⅲ and Ⅳ (40.0% and 30.0%, respectively). The postoperative tracheotomy rate was 30.6% (15/49), and the incidence of postoperative bleeding was 6.1% (3/49). The 1-year and 3-year overall survival rates were 98.0% and 92.5%, respectively, while the 1-year and 3-year disease-free survival rates were 89.2% and 84.9%, respectively. No significant differences were observed between the p16-positive and p16-negative groups in 3-year overall survival (100% vs. 83.8%, χ2=1.093, P=0.518) or 3-year disease-free survival (68.2% vs. 88.9%, χ2=2.161, P=0.382). Conclusion: TORS for malignant tongue base tumors demonstrates high clinical safety and favorable oncological outcomes.

PMID:40113566 | DOI:10.3760/cma.j.cn115330-20240806-00464

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Transoral robotic surgery of tonsillar squamous cell carcinoma: analysis of 157 cases from five medical centers

Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2025 Mar 20;60:258-265. doi: 10.3760/cma.j.cn115330-20240806-00463. Online ahead of print.

ABSTRACT

Objective: To explore the clinical application value of transoral robotic surgery (TORS) in the treatment of tonsil squamous cell carcinoma (TSCC). Methods: A retrospective analysis was conducted. The clinical data of 157 TSCC patients were collected who received TORS at five medical centers, namely the Sun Yat-sen University Cancer Center, Sun Yat-sen Memorial Hospital, Eye Ear Nose and Throat Hospital of Fudan University, the First Affiliated Hospital of China Medical University, and Tongji Hospital of Tongji Medical College, from 1 January 2017 to 31 July 2022. There were 130 males and 27 females, aged 24-85 years. All patients were followed-up at least for 2 years (2-year group), among them, 99 patients had a follow-up of 3 years (3-year group). The overall survival (OS), progression-free survival (PFS), clinical stage, human papillomavirus (HPV) infection status were analyzed. SPSS 25.0 and SAS 9.4 were used for statistical analysis. Results: The OS and PFS of the 2-year group were 91.7% and 87.9%, respectively. The OS and PFS of the 3-year group were 85.9% and 82.8%, respectively. The prognosis of patients with locally early-stage was better than that of locally advanced patients, with the OS of 94.4% for T1-2 vs. 78.0% for T3 (P=0.005) and the PFS of 91.2% for T1-2 vs. 75.0% for T3 (P=0.011) in the 2-year group; the OS of 91.1% for T1-2 vs. 65.0% for T3 (P=0.004) and the PFS of 88.6% for T1-2 vs. 60.0% for T3 (P=0.002) in the 3-year group; and also the OS of 90.0% for stage Ⅰ-Ⅱ vs. 79.5% for stage Ⅲ-Ⅳ (P=0.204) and the PFS of 86.7% for stage Ⅰ-Ⅱ vs. 76.9% for stage Ⅲ-Ⅳ (P=0.188) in the 3-year group. The prognosis of HPV-positive TSCC patients was better than that of HPV-negative patients in the 3-year group, with the OS of 90.9% for HPV-positive vs. 80.5% for HPV-negative (P=0.045) and the PFS of 90.9% for HPV-positive vs. 75.6% for HPV-negative (P=0.047). The average time of postoperative tracheal cannula indwelling was 25.1 days. The indwelling rate and average indwelling time of the postoperative nasogastric tube were 94.3% (148/157) and 8.5 days, respectively. Conclusion: TORS has outstanding survival benefits for TSCC patients. HPV-positive TSCC patients have a better prognosis than HPV-negative patients. TORS treatment of TSCC patients has advantages in postoperative recovery and quality of life.

PMID:40113565 | DOI:10.3760/cma.j.cn115330-20240806-00463

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Complication of transoral robotic surgery: single institution study

Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2025 Mar 20;60:300-304. doi: 10.3760/cma.j.cn115330-20240423-00227. Online ahead of print.

ABSTRACT

Objective: To investigate the complications of transoral robotic surgery (TORS) and to identify the risk factors for the complications. Methods: This was a retrospective study of 134 cases of head and neck tumors underwent TORS at the Department of Surgery of Beijing United Family Hospital from September 2017 to June 2024. There were 9 cases of benign tumors and 125 cases of malignant tumors, including 119 squamous cell carcinomas, 3 adenocarcinomas, 2 lymphomas, and 1 sarcoma. There were 37 cases of pure TORS and 97 cases of TORS combined with neck dissection. Postoperative complications within 90 days were collected and graded with the Clavien-Dindo system. χ2 test was used for statistical analysis. Results: A total of 25 (18.7%) cases experienced surgical complications, including 9 cases with Clavien-Dindo grade≥Ⅲ complications. Postoperative complications included 2 cases of death, 3 cases of massive hemorrhage, 3 cases of pharyngeal fistula, 2 cases of aspiration pneumonia, 2 cases of minor bleeding, 1 case of tooth injury, 1 case of arytenoid dislocation, 2 cases of tongue laceration, and 10 cases of long-term (>3 months) tracheostomy open. Postoperative pharyngeal fistula was significantly correlated with the scope of neck dissection (χ2=9.86, P<0.05), and Clavien-Dindo grade≥Ⅲ complications were significantly correlated with the scope of neck dissection (χ2=13.91, P<0.05) and tumor N stage (χ2=14.33, P<0.05). Conclusion: The high N-stage and neck dissection involving more than three regions are risk factors for the complications of TORS for head and neck tumors.

PMID:40113561 | DOI:10.3760/cma.j.cn115330-20240423-00227

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Distortion of printed resin surgical guides after autoclave sterilization and chemical disinfection

J Prosthet Dent. 2025 Mar 19:S0022-3913(25)00201-X. doi: 10.1016/j.prosdent.2025.02.052. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: Advances in implant planning have increased the use of printed surgical guides for precise implant placement. Accurate placement of implants relies on the stability of the surgical guide, therefore the effects of sterilization and disinfection on the dimensional accuracy of surgical guides require evaluation.

PURPOSE: The purpose of this in vitro study was to examine the level of distortion of printed surgical guides after steam sterilization and disinfection by immersion in 70% isopropyl alcohol to develop a protocol for the sterilization of surgical guides.

MATERIAL AND METHODS: A surgical guide was designed in Blue Sky Bio. Forty guides were printed with Formlabs Form 3B+ printer and Formlabs surgical guide resin following manufacturer’s instructions. Each guide was scanned with Primescan optical scanner before disinfection and sterilization. Twenty guides were individually packaged, and autoclave sterilized following manufacturer’s recommendation of 134 °C for 20 minutes. The remaining 20 guides were soaked in 70% isopropyl alcohol for 15 minutes. After sterilization and disinfection, the guides were scanned and standard tessellation language (STL) files from pre- and post-sterilization were compared by using the GeoMagic Control X software program to examine dimensional changes. Differences among the study groups were analyzed with a 1-sample t test to determine if the mean site’s value for each treatment group was statistically significant from zero and a 2-way repeat-measures ANOVA was used to detect differences among groups (α=.05).

RESULTS: The average deviation at the lingual, incisal, and buccal sites of the sterilized guides was 6.3 µm, -2.3 µm, and -20.6 µm, respectively. The average deviation at the lingual, incisal, and buccal sites of the chemically disinfected guides was -0.4 µm, 2.6 µm, and -0.8 µm, respectively. Sterilization showed a statistically significant value at the lingual and buccal surface (P<.05), while the chemical disinfection group did not show a statistically significant difference at any site (P>.05). The 2-way repeat-measures ANOVA test demonstrated there was a significant effect of treatment on the overall mean values (P<.001), with sterilization treatment giving an overall value 6.3 µm more negative than disinfection. There was also a significant effect of site (P<.001), and a significant interaction between treatment and site (P<.001).

CONCLUSIONS: Heat sterilization caused a significantly greater negative deviation than disinfection across the sites. A statistically significant distortion was found after sterilization, but not with chemical disinfection. However, the amount of distortion will likely not cause a clinically significant effect on the deviation of implant placement.

PMID:40113529 | DOI:10.1016/j.prosdent.2025.02.052

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Comparison of color measurements using three different spot measurement colorimetric devices applied to natural teeth

J Prosthet Dent. 2025 Mar 19:S0022-3913(25)00176-3. doi: 10.1016/j.prosdent.2025.02.028. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: The variability in color measurements between different dental devices complicates the accurate selection of tooth shades, which is crucial for esthetic dental restorations. Understanding the correlations between different devices can provide equations for inter-conversion, facilitating more consistent shade selection.

PURPOSE: The purpose of this clinical study was to evaluate and compare the colorimetric values measured from human teeth using colorimetric devices of the spot measurement type, including a conventional spectrophotometer, an intraoral spectrophotometer, and an intraoral colorimeter, and to develop inter-conversion equations based on device correlations.

MATERIAL AND METHODS: Forty healthy, non-smoking ethnic Korean volunteers aged 25 to 36 years with no anterior restorations or abnormal dental conditions were enrolled. Color measurement was made using a CM-700d spectrophotometer (Konica Minolta) (CM), Vita Easyshade intraoral spectrophotometer (Vita Zahnfabrik) (ES), and ShadeEye NCC colorimeter (Shofu) (SE) under controlled lighting conditions on maxillary central incisors using a transparent ethylene-vinyl acetate tooth guide with holes to ensure precise probe placement. ΔEab and ΔE00 values indicated color differences between devices. Statistical analyses included Pearson correlation and regression to assess inter-device variations, with intraclass correlation coefficients calculated for intra-examiner reliability (α=.05).

RESULTS: Mean L* values for CM, ES, and SE in the maxillary central incisors were 66.1, 81.4, and 72.8, respectively. The mean a* values were 0.7, -0.9, and -0.4, while the mean b* values were 10.1, 16.3, and 12.3, respectively. The largest color discrepancies were observed between CM and ES. The r2 values between each pair of devices for colorimetric values ranged from 0.111 to 0.488 (P<.01). Intra-examiner reliability was CM: L*=0.916, a*=0.826, and b*=0.797; ES: L*=0.984, a*=0.991, and b*=0.988; and SE: L*=0.940, a*=0.636, and b*=0.996.

CONCLUSIONS: The findings suggest that values can be converted between different devices and compared against standard references measured by each device. This will help in understanding changes in tooth color measured on one device in terms of another.

PMID:40113527 | DOI:10.1016/j.prosdent.2025.02.028

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Accuracy of bi-coordinate and multi-coordinate handpiece calibration methods for robot-assisted implant placement

J Prosthet Dent. 2025 Mar 19:S0022-3913(25)00205-7. doi: 10.1016/j.prosdent.2025.02.057. Online ahead of print.

ABSTRACT

STATEMENT OF PROBLEM: To ensure accurate robot-assisted surgery, it is essential to identify the handpiece position at the end effector of the robotic arm. Clinically, the relationship between the optical tracking device and the handpiece has been typically confirmed by using a calibration plate at the end effector of the robotic arm. However, the accuracy of the handpiece calibration methods for robot-assisted implant placement remains unclear.

PURPOSE: The purpose of this in vitro study was to evaluate the accuracy of bi-coordinate and multi-coordinate handpiece calibration methods, as well as the multi-coordinate handpiece plate under partial obstruction, in the context of robot-assisted implant placement.

MATERIAL AND METHODS: In total, 120 implants were divided into 6 groups based on the calibration plate used in the study: bi-coordinate handpiece calibration plate for the maxilla (Bmx), bi-coordinate handpiece calibration plate for the mandible (Bmn), multi-coordinate handpiece calibration plate for the maxilla (Mmx), multi-coordinate handpiece calibration plate for the mandible (Mmn), partially obscured multi-coordinate handpiece calibration plate for the mandible with the primary coordinate unblocked and the auxiliary coordinate covered (MmnPrim), and partially obscured multi-coordinate handpiece calibration plate for the mandible with the auxiliary coordinate unblocked and the primary coordinate covered (MmnAux). Calibration of the robotic arm was conducted separately for each group. Then the robot autonomously performed osteotomies and implant placements at the first and second premolars according to the preoperative plan. Following surgery, the robotic software program calculated the deviation values between the planned and actual implant positions. Differences between the test groups were analyzed using 1-way analysis of variance (ANOVA) and the Bonferroni post hoc test (α=.05).

RESULTS: The ranges of angular deviation and 3-dimensional deviations at the implant platform and apex across the 6 groups were 0.30 degrees to 0.48 degrees, 0.31 to 0.36 mm, and 0.31 to 0.38 mm, respectively. No statistically significant differences were found among the groups (P>.05).

CONCLUSIONS: Both the bi-coordinate and multi-coordinate handpiece calibration methods demonstrated acceptable accuracy for robot-assisted implant placement. The multi-coordinate calibration plate provides a feasible method for robot calibration in scenarios where the mandible is partially obstructed.

PMID:40113526 | DOI:10.1016/j.prosdent.2025.02.057