Evaluation of the robustness of randomized controlled trials for the treatment modalities of esophageal cancer using the fragility index - a systematic review.

BACKGROUND: Esophageal cancer remains a significant global health challenge. Several treatment modalities were explored in randomized controlled trials (RCTs) in recent decades. This study evaluates the robustness of RCTs focusing on esophageal cancer treatment using the fragility index (FI) and reverse fragility index (RFI). METHODS: A systematic review of RCTs studying different treatment modalities for esophageal cancer from 2000 to 2023 was conducted. The FI and RFI were utilized to gauge the robustness of statistically significant and non-significant outcomes, respectively. The FI represents the minimal number of patient outcomes that would need to alter to overturn a trial's statistical significance, while RFI indicates the minimal changes required to achieve significance in non-significant results. RESULTS: Out of 4028 studies retrieved, 21 RCTs were included for final analysis. The studies spanned 2001 to 2023 with a mean followup of 66 months (range, 29-108 months) and median number of patients of 194 (range, 45-802). The most common treatment modalities examined in these studies were neoadjuvant chemoradiotherapy (n = 7, 33.3%), neoadjuvant chemotherapy (n = 4, 19.0%), and neoadjuvant immunotherapy (n = 2, 9.5%). Only 5 studies (23.8%) had a statistically significant primary outcome result with a median FI of 6 (IQR, 2.5-8.5). Non-significant primary outcomes were seen in 16 studies (76.2%) with a median RFI of 4 (IQR 1-11) and lost to followup of 0 (IQR 0-4). In the study with the highest FI (10), the FI was lower than the number of patients lost to followup (13). CONCLUSION: Our findings demonstrate that most RCTs on esophageal cancer treatments did not report significant primary outcomes. The few studies that reported significant results had a low fragility index, suggesting a vulnerability in their findings.

Inflammatory bowel disease in families with four or more affected first-degree relatives.

BACKGROUND: Family history increases the risk for inflammatory bowel diseases (IBDs). However, data on differences in phenotypic characteristics among patients with a strong family history of IBD are scarce and controversial. The aim of the study was to compare the phenotypic features of IBD patients with four or more affected first-degree relatives with sporadic cases of IBD. METHODS: Patients with familial and sporadic IBD were identified from the institutional IBD database. IBD patients from families with at least four first-degree affected relatives were selected for analysis and were compared to non-matched sporadic cases with IBD chosen randomly. Comparison for type of IBD (Crohn's disease (CD) vs. ulcerative colitis (UC)), age at onset as well as for disease extent, behavior, extraintestinal manifestations and indicators of severe disease were analyzed. RESULTS: Thirty-five patients with familial IBD (28 CD, seven UC) were compared to 88 sporadic IBD patients (61 CD, 24 UC and three IBDU). Disease duration was 10.3 ± 8.2 in the familial and 8.0 ± 7.2 years in the sporadic cases, p=.13. The familial cases were younger at diagnosis (19.3 ± 8.6 vs. 25.7 ± 11.8, p=.004). Patients with familial compared to sporadic IBD were significantly more likely to require steroid treatment (80% vs. 54.5%, p=.009), biological treatment (94.3%, vs. 63.6%, p<.001) or surgery (25.7%, vs. 11.4%, p=.048). CONCLUSIONS: IBD with a very strong positive family history is associated with younger age at onset and a more adverse IBD phenotype compared to sporadic IBD.

The effect of mechanical bowel preparation on postoperative complications in laparoscopic right colectomy: a retrospective propensity score matching analysis.

PURPOSE: To assess whether full bowel preparation affects 30-day surgical outcomes in laparoscopic right colectomy for colon cancer. METHODS: A retrospective chart review of all elective laparoscopic right colectomies performed for colonic adenocarcinoma between Jan 2011 and Dec 2021. The cohort was divided into two groups-no bowel preparation (NP) group and patients who received full bowel preparation (FP), including oral and mechanical cathartic bowel preparation. All anastomoses were extracorporeal stapled side-to-side. The two groups were compared at baseline and then were matched using propensity score based on demographic and clinical parameters. The primary outcome was 30-day postoperative complication rate, mainly anastomotic leak (AL) and surgical site infection (SSI) rate. RESULTS: The original cohort included 238 patients with a median age of 68 (SD 13) and equal M:F ratio. Following propensity score matching, 93 matched patients were included in each group. Analysis of the matched cohort showed a significantly higher overall complication rate in the FP group (28 vs 11.8%, p = 0.005) which was mostly due to minor type II complications. There were no differences in major complication rates, SSI, ileus, or AL rate. Although operative time was significantly longer in the FP group (119 vs 100 min, p ≤ 0.001), length of stay was significantly shorter in the FP group (5 vs 6 days, p = 0.001). CONCLUSIONS: Aside from a shorter hospital stay, full mechanical bowel preparation for laparoscopic right colectomy does not seem to have any benefit and may be associated with a higher overall complication rate.

Small Bowel Obstruction in Patients without Prior Abdominal Surgery: To Operate or Not?

INTRODUCTION: Surgical exploration is still considered mandatory in the setting of small bowel obstruction (SBO) in patients without prior intra-abdominal surgery. However, recent studies have challenged this 'classic' approach describing success with conservative non-surgical treatment. The aim of this study is to identify clinical, radiological and biochemical variables that may be associated with the absence of intra-abdominal pathology in patients with SBO who have not undergone previous surgery. METHODS: This is a retrospective cohort study of prospectively recorded data. Patients with SBO without prior abdominal surgery who presented to a single tertiary referral medical center between 2009 and 2019 were included. RESULTS: Eighty-seven patients were included of whom 61(70.0%) were allocated to the 'therapeutic exploration' group and 26 (30.0%) to the 'non-therapeutic exploration' group. Forty-eight patients (55.0%) had adhesions, 17.2% had closed-loop obstruction, 10.0% had an internal hernia, 27.6% had bowel ischemia and 5.7% had bowel necrosis. Although multiple clinical, laboratory, radiological and preoperative factors were examined, none were significantly associated with pathological findings during surgical exploration. There was no statistically significant difference in the incidence of complications when comparing between those groups. CONCLUSIONS: In this series, no variables were associated with intra-abdominal pathology in patients who underwent surgery for SBO with no history of prior abdominal surgery. However, the fact that 27.0% had ischemic bowel upon surgical exploration suggests that this approach is still mandatory for this specific group of patients. Furthermore, clinicians and patients should be aware that negative exploration may be expected in up to 30.0%.

Pyogenic Liver Abscess: Contemporary Trends in a Tertiary Institute.

Background: Pyogenic liver abscess (PLA) is an uncommon but potentially life-threatening condition. In recent years, advances in diagnostics and management have led to early diagnosis and treatment and decreased mortality. We present recent data from a large series of patients with PLA and examine the trends in the management of PLA over a period of 50 years. Methods: The medical records of all patients admitted to the Shaare Zedek Medical Center, Israel, between January 2011 and December 2021 with a primary or secondary diagnosis of PLA were reviewed retrospectively. Results: : Ninety-five patients with PLA were identified. Thirty-eight (40%) were female. The median patient age was 66 years (range 18-93). The diagnosis of PLA in all patients was confirmed with abdominal computed tomography (CT). In twenty patients (21.1%), PLA was not diagnosed by the initial abdominal US. Most abscesses were right-sided. Biliary tract origin was the most common underlying cause of PLA (n = 57, 60%), followed by cryptogenic etiology (n = 28, 30%). Escherichia coli, Klebsiella pneumoniae, and Streptococcus species were most commonly identified. The most common primary treatment modality was percutaneous drainage (PD), which was performed in 81 patients (85.3%). Fourteen patients (14.7%) were treated medically without intervention, and two patients (2.1%) were treated surgically following a failure of PD. Four patients died as a direct result of PLA. Conclusions: Patients diagnosed with PLA are older, the male predominance is less pronounced, and the offending pathogens are likely to originate from the biliary tract. This study questions the utility of abdominal US as the initial diagnostic imaging in patients with suspected PLA (versus CT) and demonstrates improved outcomes for patients with PLA over the years.

[SARCOPENIA IS AN INDEPENDENT RISK FACTOR FOR DELAYED GASTRIC EMPTYING AFTER PANCREATICODUODENECTOMY].

BACKGROUND: Sarcopenia is defined as the degenerative loss of skeletal muscle and can be measured using the cross-sectional diameter of the psoas muscle on computed tomography. Sarcopenia has been associated with a variety of post-operative complications. We propose that sarcopenia acts as an independent factor predictive of delayed gastric emptying (DGE) after elective pancreaticoduodenectomy (PD). METHODS: A retrospective analysis of a prospectively maintained database of all patients undergoing PD at our tertiary hepatobiliary center was performed for the period December 2014 - March 2017. For each patient, the preoperative cross-sectional diameter of the psoas muscle at the upper border of L4 was calculated. Measurements in the lowest third of gender specific groups were considered to be sarcopenic. The presence of DGE, post-operative pancreatic fistulas (POPF) and major postoperative complications graded as Clavien Dindo III or more were included in the analysis. RESULTS: A total of 40 patients were included, 15 (37.5%) of whom were classified as sarcopenic. Comparison between the sarcopenic and non-sarcopenia groups revealed homogeneity in terms of gender, age, BMI and pre-operative albumin levels. DGE occurred in 11 patients (27.5%) of whom 7 were sarcopenic. Significantly more sarcopenic patients suffered from DGE (7/15 vs 4/25, p = 0.042). Major postoperative complications and POPF occurred in 15 patients each (37.5%). Nevertheless, sarcopenia was not significantly associated with POPF or other complications. The presence of sarcopenia was found to have a significant relationship with the incidence of DGE (OR 4.594, 95% CI 1.052-20.057). DISCUSSION: Sarcopenia acted as an independent risk factor predicting DGE after PD but not for POPF or other major postoperative complications.

Magnetic resonance imaging for acute appendicitis in pregnancy: can clinical scores predict when imaging is needed?

PURPOSE: Advanced imaging may augment the diagnostic milieux for presumed acute appendicitis (AA) during pregnancy, however it is not clear when such imaging modalities are indicated. The aim of this study was to assess the sensitivity and specificity of clinical scoring systems with the findings on magnetic resonance imaging (MRI) of AA in pregnant patients. METHODS: A retrospective cohort study between 2019 and 2021 was performed in two tertiary level centers. Pregnant patients presenting with suspected AA and non-diagnostic trans-abdominal ultrasound who underwent MRI as part of their evaluation were identified. Patient demographics, parity, gestation, presenting signs, and symptoms were documented. The Alvarado and Appendicitis Inflammatory Response (AIR) score for each patient were calculated and correlated with clinical and MRI findings. Univariate analysis was used to identify factors associated with AA on MRI. RESULTS: Of the 255 pregnant patients who underwent MRI, 33 (13%) had findings of AA. On univariate analysis, presentation during the second/third trimester, migration of pain, vomiting and RLQ tenderness correlated with MRI findings of AA. Whilst 5/77 (6.5%) of patients with an Alvarado score ≤4 had signs of AA on MRI, a score of ≥5 had a sensitivity, specificity, negative and positive predictive value of 84.8%, 36.6%, 94.0% and 17.2%. For an AIR score ≥ 5, this was 78.8%, 41.5%, 93.0%, and 16.7%, respectively. CONCLUSIONS: Whilst clinical scoring systems may be useful in identifying which pregnant patients require MRI to be performed when AA is suspected, the low sensitivity implies further research is needed to refine the use of this valuable resource.

Anorectal Malignancies Presenting as a Perianal Abscess or Fistula.

BACKGROUND: Acute anorectal abscess and fistula are common conditions that usually presents as a painful lump close to the anal margin. Tumors in the distal rectum and in the perianal region may mimic the symptoms and signs of anorectal sepsis, thereby leading to a delay in diagnosis and management. The purpose of this study was to describe patients presenting with acute perianal abscess or fistula who were subsequently diagnosed with anorectal cancer. METHODS: We performed a retrospective, review of all cases presenting with acute perianal abscess or fistula who were subsequently found to have anorectal carcinoma on biopsy in two tertiary centers. We analyzed the data focusing on the clinical features, laboratory values, clinical staging of the tumors, the subsequent management, the pathological staging, and the outcome of each patient. RESULTS: Overall, 3219 patients presenting with anorectal abscess or fistula were reviewed. Cancer was diagnosed in 16 (.5%) patients, 12 with adenocarcinoma of the rectum and 4 with squamous cell carcinoma of the anus. In 5 patients (31.2%), cancer was diagnosed in the setting of chronic perianal fistula, 4 of them had Crohn's disease. In 10 patients (62.5%), cancer was not diagnosed during the initial evaluation of the acute symptoms. CONCLUSIONS: A high index of suspicion is required to make the diagnosis of perianal tumors when assessing patients presenting with perianal sepsis, particularly those with Crohn's disease, a long history of persistent perianal disease, and an advanced age. In most cases, proper drainage followed by proximal diversion are the surgical treatment of choice in the acute setting.

Sarcopenia is associated with a greater incidence of delayed gastric emptying following pancreaticoduodenectomy.

BACKGROUND AND AIMS: Sarcopenia is the degenerative loss of skeletal muscle and has been associated with a variety of post-operative complications. We propose sarcopenia is associated with delayed gastric emptying (DGE) following elective pancreaticoduodenectomy (PD). METHODS: A retrospective analysis of a computerised database maintained in real time of all patients undergoing PD within our hepatobiliary unit was performed. The cross-sectional area of the psoas muscle at the upper border of L3 was calculated and corrected for patient height. The lowest quartile of gender specific groups was considered to be sarcopenic. RESULTS: 61 patients were included, 32 male and 29 female of whom 8 from each group were sarcopenic (26.2%). Although the sarcopenic and non-sarcopenia groups were found to be comparable, significantly more sarcopenic patients were older (75 vs 64 years, p = 0.003), had a lower body mass index (21.9 vs 25.0 kg/m2, p = 0.003) and suffered from DGE (7/16 vs 8/45, p = 0.045). On multivariate analysis, these variables maintained their significance with DGE having an OR of 6.042 (p = 0.036). CONCLUSION: Sarcopenia is significantly associated with DGE, older age and lower BMI in this specific cohort of patients. Further research into the reversibility of this phenomenon is warranted.