Effectiveness of pyloric exclusion (PEX) in treating duodenal trauma

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One discussion this week involved the use of pyloric exclusion (PEX) for management of severe duodenal injuries.

References: DuBose JJ, et al. Pyloric exclusion in the treatment of severe duodenal injuries: results from the National Trauma Data Bank. The American Surgeon. 2008 Oct;74(10):925-929.

Malhotra A, et al. Western Trauma Assoication Critical Decisions in Trauma: Diagnosis and management of duodenal injuries. Journal of Trauma and Acute Care Surgery. 2015 Dec;79(6):1096-1101. doi: 10.1097/TA.0000000000000870

Summary: Using the American College of Surgeons National Trauma Data Bank (v 5.0), DuBose et al (2008) evaluated adult patients with severe duodenal injuries [AAST Grade > or = 3] undergoing primary repair only or repair with PEX within 24 hours of admission.  Of the 147 patients, 28 (19.0%) underwent PEX [15.9% (11/69) Grade III vs 34.0% (17/50) Grade IV-V]. Their main findings were:

  • PEX was associated with a longer mean hospital stay (32.2 vs 22.2 days, P = 0.003).
  • PEX was not associated with a mortality benefit.
  • There was a trend toward increased development of septic abdominal complications (intra-abdominal abscess, wound infection, or dehiscence) with PEX that was not statistically significant.
  • After multivariable analysis using propensity score, no statistically significant differences in mortality or occurrence of septic abdominal complications was noted between those patients undergoing primary repair only or PEX.

DuBose et al (2008) conclude that the use of PEX in patients with severe duodenal injuries may contribute to longer hospital stay and confers no survival or outcome benefit.

The Western Trauma Association guidelines for management of duodenal injuries (Malhotra et al, 2015) include the algorithm below for determining management:

duodenal screenshot

Additional reading: Ginzburg E, et al. Pyloric exclusion in the management of duodenal trauma: is concomitant gastrojejunostomy necessary? The American Surgeon. 1997 Nov;63(11):964-966.

ONCOTYPE IQ for DCIS: A 12-year update on the ECOG-ACRIN E5194 study

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One discussion last week included Dr. Wood’s ONCOTYPE IQ for DICS, Trial E5194.

Reference: Solin LJ, et al. Surgical excision without radiation for ductal carcinoma in situ of the breast: 12-year results from the ECOG-ACRIN E5194 study. Journal of Clinical Oncology. 2015 Nov 20;33(33):3938-3944. doi: 10.1200/JCO.2015.60.8588

ClinicalTrials.gov NCT00002934.

Summary: The Eastern Cooperative Oncology Group–American College of Radiology Imaging Network (ECOG-ACRIN; formerly the Eastern Cooperative Oncology Group) Cancer Research Group E5194 study (a nonrandomized clinical trial) prospectively enrolled patients for whom surgical excision alone (without radiation) was thought to be a reasonable treatment option on the basis of low-risk clinical and pathologic characteristics. This report provides updated results from the ECOG-ACRIN E5194 study, including 10- and 12-year outcomes.

Continue reading →

The ACOSOG Z0011 Randomized Control Trial

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One discussion last week included the ACOSOG Z0011 RCT.

Reference: Giuliano AE, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: the ACOSOG Z0011 (Alliance) randomized control trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.

Summary: The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years. Longer follow-up was necessary because the majority of the patients had estrogen receptor-positive tumors that may recur later in the disease course. In this follow-up study, the authors sought to determine whether the 10-year overall survival of patients with 2 or fewer sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection.

Compared with ALND, SLND alone was found to be noninferior for overall survival. The 10-year overall survival rate was 86.3% in the SLND alone group and 83.6% in the ALND group. The unadjusted HR comparing overall survival between the SLND alone group and the ALND group was 0.85 (1-sided 95% CI, 0–1.16), which did not cross the prespecified noninferiority HR margin of 1.3. The HR for overall survival adjusting for adjuvant therapy (chemotherapy, endocrine therapy, radiation, or a combination of these 3) and age for the SLND alone group compared with the ALND group was 0.93 (1-sided 95% CI, 0–1.28) (Table 2).

10yr survival

CONCLUSION: In this randomized clinical trial including 856 women, after median follow-up of 9.3 years, overall survival for patients treated with sentinel lymph node dissection alone was not inferior to those treated with completion axillary lymph node dissection (86.3% vs 83.6%, respectively; noninferiority hazard ratio margin of 1.3). These findings do not support the use of axillary lymph node dissection when 2 or fewer metastases are found with sentinel lymph node sampling in women with cT1-2M0 breast cancer.

Lobectomy vs total thyroidectomy for intermediate-size papillary thyroid cancer

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One discussion last week included the extent of surgery for intermediate-size papillary thyroid cancer: lobectomy vs total thyroidectomy.

Reference: Adam MA, et al. Extent of surgery for papillary thyroid cancer is not associated with survival: an analysis of 61,775 patients. Annals of Surgery. 2014 Oct;260(4):601-605. doi:10.1097/SLA.0000000000000925.

Summary: Guidelines recommend total thyroidectomy for PTC tumors >1 cm, based on older data demonstrating an overall survival advantage for total thyroidectomy over lobectomy.

Adult patients with PTC tumors 1.0-4.0 cm undergoing thyroidectomy in the National Cancer Database between 1998-2006 were included, totaling 61,775 patients. Median follow-up was 82 months (range, 60-179 months).

Lobectomy (n=6849)

Total thyroidectomy (n=54,926)
Nodal disease

7%

27%
Extrathyroidal disease

5%

16%
Multifocual disease

29%

44%

After multivariable adjustment, overall survival was similar in patients undergoing total thyroidectomy versus lobectomy for tumors 1.0-4.0 cm and when stratified by tumor size: 1.0-2.0 cm and 2.1-4.0 cm. Older age, male sex, black race, lower income, tumor size, and presence of nodal or distant metastases were independently associated with compromised survival (P < 0.0001).

Adam et al (2014) conclude that although current guidelines suggest total thyroidectomy for PTC tumors >1 cm, they did not observe a survival advantage associated with total thyroidectomy compared with lobectomy. These findings call into question whether tumor size should be an absolute indication for total thyroidectomy.

Hepaticojejunostomy vs end-to-end biliary reconstructions in treatment of bile duct injury

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One discussion this week included treatments for bile duct injury.

Reference: Jablonska B, et al. Hepaticojejunostomy vs end-to-end biliary reconstructions in the treatment of iatrogenic bile duct injuries. Journal of Gastrointestinal Surgery. 2009 Jun;13(6):1084-1093. doi:10.1007/s11605-009-0841-7.

Summary: Iatrogenic bile duct injuries (IBDI) most frequently develop during cholecystectomy. An increase in patients with IBDI has been associated with the widespread use of laparoscopic cholecystectomy (p.1084).

Jablonska et al (2009) clarify that the Roux-Y hepaticojejunostomy (HJ) is the most frequently recommended type of reconstruction. End-to-end ductal anastomosis (EE) is used very seldom in the surgical treatment of IBDI but is performed during hepatic transplantation with good results.

In this study by Jablonska et al (2009), 94 patients underwent reconstructive surgery for IBDI (49, Roux-Y HJ, and 45, EE) between January 1990 and March 2005. The major findings include:

  • Early complications occurred more after HJ (24.5%) than after EE (6.7%).
  • Wound infection was most frequent early complication: 16.3% of HJ group, 2.2% of EE group.
  • HJ group saw 2% early postoperative mortality rate, and 8% early reoperations rate. EE group saw no mortality, no early reoperations.
  • Excellent/good long-term results were observed in 78.94% of HJ group, and 77.42% of EE group.
  • Recurrent stricture was observed in 2 HJ patients (5.3%) and 3 EE patients (9.6%).
  • Quality of life in both groups was comparable.

“This study emphasizes that it is possible to achieve very good long-term results and high quality of life using both HJ and the EE” (p.1092).

Bloodstream infection rates: PICC vs CVC

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One discussion this week involved the comparison of bloodstream infection rates with PICCs vs CVCs.

Reference: Chopra V, et al. The risk of bloodstream infection associated with peripherally inserted central catheters compared with central venous catheters in adults: a systematic review and meta-analysis. Infection Control and Hospital Epidemiology. 2013 Sep;34(9):908-918. doi:10.1086/671737.

Summary: In 23 studies involving 57,250 patients, pooled meta-analyses revealed that PICCs were associated with a lower risk of central line-associated bloodstream infection (CLABSI) than were CVCs. A subgroup analysis further showed that CLABSI reduction was greatest in outpatients (RR [95% CI], 0.22 [0.18-0.27]) compared with hospitalized patients who received PICCs (RR [95% CI], 0.73 [0.54-0.98]).

The authors conclude that although PICCs are associated with a lower risk of CLABSI than CVCs in outpatients, hospitalized patients may be just as likely to experience CLABSI with PICCs as with CVCs. Consideration of risks and benefits before PICC use in inpatient settings is warranted.

Treatment in uremic bleeding

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One discussion this week involved the treatment for uremic bleeding.

Reference: Hedges SJ, et al. Evidence-based treatment recommendations for uremic bleeding. National Clinical Practice. Nephrology. 2007 Mar;3(3):138-153.

Summary: Hedges et al (2007) provide a review of normal hemostatic and homeostatic mechanisms that operate within the body to prevent unnecessary bleeding, as well as an in-depth discussion of the dysfunctional components that contribute to complications associated with uremic bleeding syndrome. Prevention and treatment options can include one or a combination of the following: dialysis, erythropoietin, cryoprecipitate, desmopressin, and conjugated estrogens.

The article cited is worth a full text read because:

  • Treatment options are compared with regard to their mechanism of action, and onset and duration of efficacy.
  • An extensive review of the clinical trials that have evaluated each treatment is also presented (Tables 3, 4, 5).
  • An evidence-based treatment algorithm to help guide clinicians through most clinical scenarios, and address common questions related to the management of uremic bleeding.

Uremic bleeding in patients with chronic renal failure is extremely complex. One factor contributing to this complexity is the incomplete elucidation of its pathophysiology. Because the mechanisms underlying uremic bleeding are not fully understood, prevention and treatment for many different clinical scenarios are not clearly defined (p.150).

  • EPO works to increase the number of red blood cells, allowing platelets to travel in closer proximity to the endothelium.
  • Cryoprecipitate and desmopressin work to increase the proportion of normal or functional factors that might be dysfunctional in patients with uremic bleeding.
  • Estrogens are thought to work by decreasing NO levels, thereby increasing concentrations of TxA2 and ADP.

Multiple interventions that simultaneously affect different aspects of the pathophysiology of uremic bleeding might most effectively prevent bleeding in high-risk patients and limit active bleeding in those for who cessation of blood loss is more pressing.

By determining which patients are most at risk, clinicians can utilize dialysis and EPO in the early stages of uremic bleeding, and employ desmopressin, cryoprecipitate and/or estrogens prior to a surgical procedure, thereby possibly preventing bleeding secondary to uremic platelet dysfunction.