Molecular hydrogen had been considered inactive in vivo but is an antioxidant that selectively reduces highly toxic reactive oxygen species (ROS). Animal studies have reported that hydrogen gas ...inhalation helped alleviate cerebral and cardiac ischemia-reperfusion injuries. In humans, hydrogen inhalation therapy is presently approved as a treatment under Advanced Medical Care B in Japan (jRCTs031180352: limited to adult patients who suffered out-of-hospital cardiac arrest and are in a continuous coma) and its effectiveness is being examined in a clinical trial. The Japanese government has introduced the "Advanced Medical Care System" to promote the development of drugs and devices under governmental regulations. Advanced Medical Care B is a system designed for unapproved or off-label drugs or medical technologies used in a clinical trial setting. Hepatectomy is generally performed with repeated hepatic blood-flow occlusion and then reperfusion (ischemia and reperfusion). No report, however, has been made on ROS inhibition by hydrogen inhalation therapy or its effectiveness in post-hepatectomy patients. Hydrogen gas inhalation in the early stages after hepatectomy is anticipated to inhibit liver dysfunction by inhibiting ROS.
This study is a randomized, controlled, double-blind superiority trial, which will be conducted as a "specified clinical trial" in accordance with the Clinical Trials Act in Japan. Trial registration was prospectively completed before the first participant was enrolled. The subjects will be patients who will undergo hepatectomy and will be allocated randomly into group A with hydrogen gas inhalation or group B with air inhalation after hepatectomy. The study will examine if hydrogen gas inhalation improves QOL of post-hepatectomy patients. The primary endpoint is patient QOL (score of a 40-item quality of recovery questionnaire, QoR40) on postoperative day 3 and the secondary endpoints are QoR40s besides that on postoperative day 3, grade of postoperative complications (Clavien-Dindo score), level of pain (Numerical Rating Scale (NRS)), amount of dietary intake, liver function, inflammation level, 8-hydroxydeoxyguanosine (urinary 8-OHdG) level, and number of pedometer-assessed steps.
The study protocol has been approved by the Niigata University Central Review Board of Clinical Research. The findings of this study will be widely disseminated through peer-reviewed publications and conference presentations.
jRCTs 03220332 . Registered on 21 January 2021.
Background
Adjuvant chemotherapy for resectable colorectal liver metastasis (CRLM) is widely used, but its efficacy lacks clear evidence. This retrospective cohort study investigated the ...effectiveness of neoadjuvant chemotherapy (NAC) compared to upfront surgery for CRLM.
Methods
Data from patients with resectable CRLM were analyzed. Short-term outcomes and long-term prognosis were analyzed using propensity score matching. CRLM was stratified according to the H-classification (H1 and H2), and the effectiveness of adjuvant chemotherapy was analyzed in each group.
Results
We analyzed 599 cases that were matched into an NAC group (
n
= 136) and an upfront surgery group (
n
= 136). The proportion of synchronous metastases, H2-classification, and postoperative chemotherapy rate did not differ between the groups. Overall survival (OS) after initial treatment was significantly worse in the NAC group than in the upfront surgery group (
P
= 0.029). The 5-, 7-, and 10-year OS rates for H1 patients were significantly better in the upfront surgery group than in the NAC group (64%, 51%, and 44% vs. 50%, 31%, and 18%, respectively) (
P
= 0.004).
Conclusion
Patients with resectable CRLM should undergo upfront surgery, because NAC did not improve OS after initial treatment in these patients.
ObjectivesThe effectiveness and impact of any treatment on patients’ physical functions, especially in older patients, should be closely considered. This study aimed to evaluate activities of daily ...living (ADLs) after oncological surgery in patients with gastrointestinal and hepatobiliary-pancreatic cancers by age groups in Japan.DesignRetrospective observational study using health services utilisation data from 1 January 2015 to 31 December 2016.SettingData for patients with gastrointestinal and hepatobiliary-pancreatic cancers diagnosed in 2015 from 431 hospitals nationwide in Japan.ParticipantsPatients who underwent endoscopic submucosal dissection (ESD), endoscopic mucosal resection (EMR) and laparoscopic or open surgery were included.Outcome measuresThe proportion of ADL decline at discharge, death and unexpected readmission within 6 weeks postsurgery was calculated by age groups (40–74, 75–79 and ≥80 years).ResultsData for 68 032 patients were analysed. The difference in the proportion of ADL decline after ESD/EMR between patients aged ≥80 years and <75 years was marginal (0.8%–2.5%), whereas that after laparoscopic (4.8%–5.9%) or open surgery (4.6%–9.4%) was large, except for pancreatic cancer (3.0%). Among patients with gastric cancer who underwent laparoscopic or open surgery, the proportion of unexpected readmission tended to be higher in patients aged ≥80 years than in the remaining younger patients (laparoscopic surgery 4.8% vs 2.3% (p=0.001); open surgery 7.3% vs 4.4% (p<0.001)). The postoperative mortality rate was <3% (<10 cases) across all ages and cancer types.ConclusionsIn ESD/EMR, postoperative ADL decline was almost the same between older and younger patients. Laparoscopic or open surgery is associated with increased rates of ADL decline in older patients, especially in those aged ≥80 years. The potential decline in ADLs should be carefully considered preoperatively to best maintain the patient’s quality of life postsurgery.
Background
Various tubes may be fixed to the skin by ligation using silk sutures after gastrointestinal surgery. We investigated the effects of a skin substitute, “Nonaht®,” on pain and skin ...inflammation at the fixation sites of various tubes.
Methods
The effects of tubes (abdominal drains, small intestinal feeding tubes, and bile duct drainage tubes) fixed in place using either silk sutures or Nonaht were compared for 1–3 months.
Results
The median pain scores at the fixation site when abdominal drains were removed were 1.0 with silk sutures and 0 with Nonaht (
p
< 0.001). Scarring at the fixation site at postoperative month (POM) 1 occurred in 13 of 28 cases in the silk suture group and in no cases in the Nonaht group (
p
< 0.001). The median pain scores at the fixation site with long-term tubes on postoperative day (POD) 14 and POM 1 were 2.0 and 1.0, respectively, with silk sutures, and none at all time points with Nonaht (
p
< 0.001). Scarring at the fixation site at POM 3 occurred in all 10 cases in the silk suture group and in no cases in the Nonaht group (
p
< 0.001).
Conclusions
Patients with conventional skin fixation of tubes using silk sutures were continuously aware of pain at the fixation site and developed skin damage and subsequent scar formation, especially for tubes inserted for ≥ 1 month. The use of Nonaht may reduce the incidence of dermatitis and wound infections at tube fixation sites, thereby promoting early postoperative recovery.
Bile leakage after subtotal cholecystectomy (SC) is clinically serious. To prevent such leakage, we developed a new surgical technique in which a free piece of omentum is plugged into the gallbladder ...stump (omentum plugging technique). We evaluated whether the omentum plugging technique prevents bile leakage after subtotal cholecystectomy.
Prospectively collected data of patients who had undergone subtotal cholecystectomy without cystic duct closure in the Department of Surgery of Kansai Medical University during the 12 years from January 2006 to March 2018 were reviewed retrospectively. The outcomes of patients who had undergone subtotal cholecystectomy with the omentum plugging technique (omentum plugging technique group) were compared with those of patients who had undergone subtotal cholecystectomy without the omentum plugging technique (Control group). The outcomes of interest were perioperative data and postoperative complications including bile leakage, necessity for interventions for complications, and duration of hospitalization.
Fifty of 2,447 consecutive patients (2.0%) had undergone subtotal cholecystectomy. Of these 50 patients, 18 were treated with the omentum plugging technique (omentum plugging technique group) and 32 were treated without the omentum plugging technique (Control group). One of 18 patients in the omentum plugging technique group and 14 of 32 in the Control group developed postoperative bile leakage. One postoperative interventional treatment for complications was performed in the omentum plugging technique group and 12 in the Control group. The duration of postoperative hospitalization was less in the omentum plugging technique group.
The omentum plugging technique appears to be an effective operative technique for preventing postoperative bile leakage in selected situations when a “difficult gallbladder” is encountered.
Background
Strict criteria for impeccably safe drain management following pancreatectomy have not yet been developed. We evaluated the utility of the sequentially‐checked drain removal criteria by ...comparison with conventional criteria.
Methods
Postoperative outcomes of 801 patients who underwent pancreatectomy, including 395 patients for whom drain fluid amylase (DFA) < 375U/l on postoperative day (POD) 3 (control group), were used and 406 patients for whom the sequentially‐checked criteria of DFA <5,000 U/l on POD 1 and DFA <3,000 U/l on POD 3 (sequentially‐checked group) were used and were retrospectively evaluated.
Results
DFA on POD 3 and fistula risk score did not differ between groups. Significantly more patients in the sequentially‐checked group met the criteria (control, 63.8% vs. sequentially‐checked, 76.1%, P < 0.001). The incidences of clinically relevant postoperative pancreatic fistula (CR‐POPF) (17.0% vs. 11.1%), intra‐abdominal abscess (21.0% vs. 9.1%) were significantly lower in the sequentially‐checked group (all P < 0.05). Multivariate analysis revealed that use of the sequentially‐checked criteria was significantly associated with CR‐POPF (odds ratio 0.601, 95% confidence interval CI 0.389–0.929; P = 0.022). C‐reactive protein <15 mg/dl at POD 3 was identified as an independent predictive factor for false positive CR‐POPF results in the sequentially‐checked group (odds ratio 0.872, 95% CI 0.811–0.939; P < 0.001); thus, this criterion was added to create the new triple‐checked criteria.
Conclusions
The sequentially‐checked criteria can provide safe drain management and improve postoperative outcomes.
Highlight
Kosaka and colleagues set out to evaluate the utility of the sequentially‐checked drain removal criteria following pancreatectomy by comparison with conventional criteria. The sequentially‐checked criteria significantly decreased the incidence of clinically relevant postoperative pancreatic fistula, intra‐abdominal abscess, and percutaneous abscess drainage, suggesting they may contribute to safer postoperative management after pancreatectomy.
Background
Pancreatoduodenectomy (PD) is a technically complex procedure. Preoperative anticipation of the degree of difficulty could contribute to patient safety during trainee surgical education.
...Methods
We prospectively administered a questionnaire to the chief surgeon after each PD performed between 2016 and 2018 at our institution (99 consecutive patients). The surgeon rated the difficulty of the procedure; we then analyzed this information against perioperative data.
Results
The difficulty of PD was ranked as simple (29.3%), moderate (40.4%), or difficult (30.3%). The difficult procedures required an operative time of 2 h longer than the simple procedures and involved an additional 800 mL of intraoperative blood loss. Postoperative complications were similar in all groups. Multivariate analysis revealed that an unrecognized tissue plane for dissection was an independent determinant of a difficult PD (odds ratio OR: 89.2, 95% confidence interval CI: 9.2‐861.2; P < .001). Independent predictors of a difficult PD were a pretreatment status of borderline resectable or unresectable (OR: 21.9, CI: 5.3‐90.6; P < .001) and cholangitis during the preoperative period (OR: 4.1, CI: 1.3‐13.0; P = .017).
Conclusions
Surgeons deem the PD procedure to be difficult when the proper tissue plane for dissection is unrecognized. Preoperative assessment of the anticipated difficulty could contribute to better operative management.
A postoperative surgeon questionnaire revealed that an unrecognized tissue plane for dissection was an independent determinant of a difficult pancreatoduodenectomy, while independent predictors were a pretreatment borderline resectable or unresectable status and preoperative cholangitis. Kosaka et al. concluded that preoperative assessment of the anticipated difficulty could contribute to better operative management.
This retrospective multicenter study aimed to evaluate the risk of postpancreatectomy hemorrhage (PPH) in patients receiving antithrombotic agents (ATAs). PPH is the most severe complication after ...pancreatectomy. However, there is little known about the strength of the association between ATA use, PPH, and other clinical outcomes.
Between 2007 and 2016, 1,297 patients underwent pancreatectomy at 2 surgical centers. ATA use included aspirin, clopidogrel, ticlopidine, warfarin, direct oral anticoagulants, and intravenous unfractionated heparin. The ATA group was composed of 144 patients who were taking ATAs before surgery.
A total of 35 patients developed PPH. The patients in the ATA group showed higher frequency (8.3% vs 2.0%, p < 0.001) of PPH compared with the control group (n = 1,153). In multivariate analysis, ATA use was an independent adverse risk factor for PPH (odds ratio OR 3.58, 95% CI 1.29–9.91, p = 0.014). Stratification by preoperative ATA therapy revealed a significant risk of PPH Grade C in patients receiving combined AT therapy. The median onset of late hemorrhage (>24 hours post-surgery) in the ATA group was later than in the control group (17.5 vs 8.5 days, p = 0.032), and the incidence tended to be higher in patients who restarted ATAs postoperatively.
History of ATA use is a significant risk factor for PPH, and postoperative resumption of ATAs appears to be associated with an increased risk of PPH. Patients receiving combined antithrombotic therapy may be at particularly high risk for PPH.
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Laparoscopic liver resection for hepatic lesions is increasingly performed worldwide. However, parenchyma-sparing laparoscopic liver resection for hepatic lesions in the right posterosuperior ...segments is very technically demanding. This study aimed to compare postoperative outcomes between patients undergoing laparoscopic liver resection and open liver resection for hepatic lesions in the right posterosuperior segments.
In total, 617 patients who underwent liver resection of hepatic lesions in the right posterosuperior segments (segment Ⅶ or Ⅷ) at 8 centers were included in this study. We lessened the impact of confounders through propensity score matching, inverse probability weighting, and double/debiased machine learning estimations.
After matching and weighting, the imbalance between the 2 groups significantly decreased. Compared with open liver resection, laparoscopic liver resection was associated with a lower volume of intraoperative blood loss and incidence of postoperative complications in the matched and weighted cohorts. After surgery, the incidence of pulmonary complication and cardiac disease was lower in the laparoscopic liver resection group than in the open liver resection group in both the matched and weighted cohorts. The odds ratios of laparoscopic liver resection for postoperative complications in the matched and weighted cohorts were 0.49 (95% confidence interval, 0.29–0.83) and 0.40 (95% confidence interval, 0.25%–0.64%), respectively. The double/debiased machine learning risk difference estimator for postoperative complications of laparoscopic liver resection was −19.8% (95% confidence interval, −26.8% to −13.4%).
Parenchyma-sparing laparoscopic liver resection for hepatic lesions in the right posterosuperior segments had clinical benefits, including lower volume of intraoperative blood loss and incidence of postoperative complications.
Background/Aim
Atezolizumab plus bevacizumab (Atez/Bev) treatment is recommended for unresechepatocellular carcinoma (u‐HCC) patients classified as Child‐Pugh A (CP‐A). This study aimed to elucidate ...the prognosis of patients treated with Atez/Bev, especially CP‐A and ‐B cases.
Materials/methods
From September 2020 to March 2022, 457 u‐HCC patients treated with Atez/Bev were enrolled (median age 74 years, male:female = 368:89, CP‐A:CP‐B = 427:30, Child‐Pugh score CPS 5:6:7:8:9 = 271:156:21:8:1). Therapeutic response was evaluated using RECIST ver.1.1. Clinical features and prognosis were retrospectively evaluated.
Results
There were no significant differences between CP‐A and ‐B patients in regard to best response (CR:PR:SD:PD = 16:91:194:81 vs. 0:7:13:8, p = 0.739; objective response rate/disease control rate = 28.0%/78.8% vs. 25.0%/71.4%). Analysis performed using inverse probability weighting adjustments of clinical factors other than those related to hepatic reserve function with a p value < 0.10 for comparisons between patients with CP‐A and ‐B showed that the progression‐free survival (PFS) rate for CP‐A cases was better (6‐/12‐/18‐month: 58.2%/36.1%/27.8% vs. 49.6%/8.7%/non‐estimable NE, p < 0.001), as was overall survival (OS) rate (6‐/12‐/18‐month: 89.9%/71.7%/51.4% versus 63.6%/18.4%/NE; p < 0.001). Median PFS (mPFS) and median OS (mOS) for the CPS‐5 were 9.5 months/NE, and 5.1/14.0 months for the CPS‐6 (both p < 0.001). Furthermore, for modified albumin‐bilirubin grade (mALBI)‐1/2a/2b, mPFS was 9.4/8.5/5.3 months (p < 0.001) and mOS was NE/17.8/13.4 months (p < 0.001).
Conclusion
Better hepatic function, such as mALBI grade 1 or 2a are thought to indicate a better condition for obtaining sufficient prognosis with Atez/Bev treatment for u‐HCC patients, whereas for CP‐B patients, who mainly shown an mALBI grade of 2b or 3, Atez/Bev might have less therapeutic efficacy.
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