Rescue from complications after pancreaticoduodenectomies at a low-volume Caribbean center: Value of tailored peri-pancreatectomy protocols.

BACKGROUND: Pancreaticoduodenectomy (PD) is a technically complex operation, with a relatively high risk for complications. The ability to rescue patients from post-PD complications is as a recognized quality measure. Tailored protocols were instituted at our low volume facility in the year 2013. AIM: To document the rate of rescue from post-PD complications with tailored protocols in place as a measure of quality. METHODS: A retrospective audit was performed to collect data from patients who experienced major post-PD complications at a low volume pancreatic surgery unit in Trinidad and Tobago between January 1, 2013 and June 30, 2023. Standardized definitions from the International Study Group of Pancreatic Surgery were used to define post-PD complications, and the modified Clavien-Dindo classification was used to classify post-PD complications. RESULTS: Over the study period, 113 patients at a mean age of 57.5 years (standard deviation [SD] ± 9.23; range: 30-90; median: 56) underwent PDs at this facility. Major complications were recorded in 33 (29.2%) patients at a mean age of 53.8 years (SD: ± 7.9). Twenty-nine (87.9%) patients who experienced major morbidity were salvaged after aggressive treatment of their complication. Four (3.5%) died from bleeding pseudoaneurysm (1), septic shock secondary to a bile leak (1), anastomotic leak (1), and myocardial infarction (1). There was a significantly greater salvage rate in patients with American Society of Anesthesiologists scores ≤ 2 (93.3% vs 25%; P = 0.0024). CONCLUSION: This paper adds to the growing body of evidence that volume alone should not be used as a marker of quality for patients requiring PD. Despite low volumes at our facility, we demonstrated that 87.9% of patients were rescued from major complications. We attributed this to several factors including development of rescue protocols, the competence of the pancreatic surgery teams and continuous, and adaptive learning by the entire institution, culminating in the development of tailored peri-pancreatectomy protocols.

A comparative clinical study of postoperative care by teleophthalmology and in-person consultation at hospital outpatient department after an uncomplicated cataract surgery.

BACKGROUND: Teleophthalmology provides an opportunity to conduct consultations in far-flung and remote areas that have no access to specialized eye care. However, there is a paucity of studies to assess the effect of missing in-person follow-up on initial postoperative visits. The study thus aims to compare postoperative satisfaction and uncorrected distance visual activity after an uneventful phacoemulsification cataract surgery in patients with teleconsultation approach to those with hospital visit. MATERIALS AND METHODS: The prospective observation study (n = 240) was conducted in patients who underwent surgery for cataract. Pre- and post-operative data were collected and divided into two groups based on the type of postoperative follow-up. All patients were scheduled for ophthalmic reviews in the hospital on day 1, day 7, and day 30-40 (hospital visit group) or through teleconsultation on days 1 and 7 followed by a hospital visit on days 30-40 (teleconsultation group). Outcomes evaluated in both groups were complications, patient satisfaction, and uncorrected distance visual acuity. RESULTS: Most patients in both groups were in the age group of 51-70 years. Overall satisfaction was comparable in teleconsultation and hospital visit groups (3.74 ± 0.23 vs. 3.72 ± 0.27; P = 0.22). The majority of patients had visual acuity 6/18-6/6 on postoperative day 1, day 7, and day 30-40 in both groups. Lid edema, pain, redness, watering, and congestion complications were more in the hospital visit group on postoperative day 1. CONCLUSION: The study concludes that patients with no preexisting ocular and systemic comorbidity undergoing an uneventful phacoemulsification cataract surgery teleconsultation approach can be used for follow-up without any impact on the postoperative visual outcome and patient satisfaction, thereby increasing the efficiency and productivity of health-care system.

Preliminary experience in laparoscopic distal pancreatectomy using the AEON™ endovascular stapler.

Background: The aim of this study is to investigate the effects of using a new innovative endovascular stapler, AEON™, on the pancreatic leak rates and other outcome measures. Methods: In a retrospective review of prospectively collected data from a secure tertiary unit registry, patients undergoing distal or lateral pancreatectomy were analyzed for any differences on pancreatic fistula rates, length of stay, comprehensive complication index (CCI), and demographics after using AEON™ compared with other commonly used staplers. Statistical significance was defined as <0.05. Results: There were no differences in the demographics between the two groups totaling 58 patients over 2 years from 2019 to 2021. A total of 43 and 15 patients underwent pancreatic transection using other staplers and AEON™ endovascular stapler, respectively. The comparison of the two groups revealed a significantly reduced rate of mean drain lipase at postoperative day 3 with AEON™ (446 U/L) versus the other staplers (4,208 U/L) (p = 0.018) and a subsequent reduction of postoperative pancreatic fistula (POPF) from 65% to 20%. A reduction in the mean CCI, from 13.80 when other staplers were used to 4.97 when AEON™ was used, was also observed (p = 0.087). Mean length of stay was shorter by 3 days in the AEON™ group compared with that in the other staplers (6 and 9 days, respectively; p = 0.018). Conclusion: AEON™ stapler when used to transect the pancreas demonstrated a significantly reduced pancreatic fistula rate, length of stay in hospital, and a leaning towards a reduced CCI. Its use should be further evaluated in larger cohorts with the encouraging results to determine whether this is possibly related to the technology used in the design of the AEON™ stapler.

A comparative study to evaluate the effect of various postoperative treatment protocols on dry eye and patient satisfaction after phacoemulsification.

Purpose: Foreign body sensation and irritation are common after cataract surgery, as is the exacerbation of dry eye disease if present. This study compared postoperative dry eye treatments and patient satisfaction. Methods: Age-related cataract patients undergoing phacoemulsification were recruited and were divided randomly into 4 postoperative treatment groups: Group A: Antibiotic + Steroids; Group B: Antibiotic + Steroids + Mydriatic; Group C: Antibiotic + Steroids + Mydriatic + Non-steroidal Ant-inflammatory drugs (NSAIDs); Group D: Antibiotic + Steroids + Mydriatic + NSAID + Tear substitute. Patients were assessed at 1, 3, and 5 weeks post-operatively for uncorrected distance and near vision, best corrected visual acuity (BCVA) for distance and near, Schirmer's-1 test, and Tear Film Break-Up Time test. At each visit, patients were assessed for dry eye-related subjective parameters using Ocular Surface Disease Index questionnaire. Results: Study participants numbered 163. (87 male and 76 female patients). No statistically significant difference was present in visual acuity for near and distance. The mean values of Schirmer's test and TFBUT were better in group D patients at each postoperative visit, with significant differences noted in comparison with other groups. The patient response to pain and dry eye symptoms was superior in groups C and D, with group D producing the best results. Compared to group A, patients in groups C and D were more satisfied with their vision and surgery. Conclusion: The addition of tear substitutes to steroids and NSAIDs has been associated with decreased dry eye-related symptoms and a better subjective feeling of vision, although no significant difference was noted in vision measured objectively.

Comparative study of anatomical and functional recovery of eye along with patient satisfaction score after small-incision cataract surgery and phacoemulsification cataract surgery.

Purpose: Functional recovery after cataract surgery depends on the anatomical recovery of the eye. This study compared the improvement in visual function parameters after uniocular manual small-incision cataract surgery (MSICS) and phacoemulsification cataract surgery. Methods: This study included 310 patients divided randomly into two groups: 155 who received MSICS (MSICS group) and 155 who underwent phacoemulsification (phaco group) for cataract treatment. Outcome measures assessed included vertical and horizontal keratometry reading. The mean corneal astigmatism tear function measured using Schirmer 1 test results were recorded preoperatively, and on postoperative day 1, day 7, and day 30. Optical coherence tomography (OCT) was done to record the average central macular thickness (µm) on day 7 and day 30. Results: The mean corneal astigmatism and anterior chamber inflammation were more in the MSICS group than in the phaco group immediately postoperatively. However, no statistically significant difference was found between the groups with respect to corneal sensation, mean corneal astigmatism, tear film function, and visual outcomes on postoperative day 30. Uncorrected visual acuity was better in the phacoemulsification group than in the manual SICS group on postoperative day 1, day 7, and day 30 (P < 0.001). Conclusion: Both phacoemulsification cataract surgery and manual small-incision sutureless cataract surgery (MSICS) are safe and effective for visual rehabilitation. Phacoemulsification is the preferred technique where resources are available with the advantages of less mean corneal astigmatism, less anterior chamber inflammation, and better uncorrected visual acuity (UCVA) in the immediate postoperative period.

Whipple's operation with a modified centralization concept: A model in low-volume Caribbean centers.

Conventional data suggest that complex operations, such as a pancreaticoduodenectomy (PD), should be limited to high volume centers. However, this is not practical in small, resource-poor countries in the Caribbean. In these settings, patients have no option but to have their PDs performed locally at low volumes, occasionally by general surgeons. In this paper, we review the evolution of the concept of the high-volume center and discuss the feasibility of applying this concept to low and middle-income nations. Specifically, we discuss a modification of this concept that may be considered when incorporating PD into low-volume and resource-poor countries, such as those in the Caribbean. This paper has two parts. First, we performed a literature review evaluating studies published on outcomes after PD in high volume centers. The data in the Caribbean is then examined and we discuss the incorporation of this operation into resource-poor hospitals with modifications of the centralization concept. In the authors' opinions, most patients who require PD in the Caribbean do not have realistic opportunities to have surgery in high-volume centers in developed countries. In these settings, their only options are to have their operations in the resource-poor, low-volume settings in the Caribbean. However, post-operative outcomes may be improved, despite low-volumes, if a modified centralization concept is encouraged.

Effects on ocular aberration and contrast sensitivity after implantation of spherical and aspherical monofocal intraocular lens - A comparative study.

Purpose: Phacoemulsification with intraocular lens (IOL) implantation is the standard of care for cataractous eyes. Monofocal IOLs are spherical or aspheric. The aspheric design of IOLs reduces the spherical and higher-order aberrations and impacts contrast sensitivity post cataract surgery. There are some studies, but data in the Indian setting with the IOLs we used is lacking. We aimed to compare the effect of implantation of spheric and aspheric foldable intraocular lenses on postoperative quality of vision, spherical aberration, and contrast sensitivity. Methods: This prospective observational study was conducted at a tertiary care hospital with an ophthalmology specialty, data collection from January 2017 to May 2018 in 100 patients. Patients meeting the inclusion criteria were selected. Their preoperative and postoperative data were collected and divided into groups based on whether spherical or aspheric IOL was implanted after cataract surgery. Variables assessed were visual acuity on days 7 and 30, spherical aberrations, and contrast sensitivity was assessed at 1-month postoperative. Results: The mean age of the patients in this study was 64 ± 8 years with a majority of patients (60%) being females. There is no significant difference in postoperative visual acuity between the two groups. Internal SA was significantly lower (~50%) in eyes implanted with aspheric IOLs (P value = 0.004, 0.0001) compared with the spherical group. Contrast sensitivity of patients of the aspheric group was significantly better (P value <0.05). Conclusion: The optical design of the aspheric IOLs reduced spherical aberrations and increased contrast sensitivity.

A fast-track surgery programme leads to timelier treatment and higher resection rates in pancreatic cancer.

BACKGROUND: The aim was to perform a propensity-matched comparison of patients with pancreatic cancer undergoing surgery, with and without biliary stenting and an intention to treat analysis of long-term survival between the two groups. METHODS: This was an observational study of a cohort of consecutive patients presenting with obstructive jaundice and undergoing pancreatoduodenectomy for pancreatic and periampullary malignancies between November 2015 and May 2019. RESULTS: In this study of 216 consecutive operable patients, 70 followed the fast-track pathway and 146 had pre-operative biliary drainage. All 70 patients in the FT group and 122 out of 146 in the PBD group proceeded to surgery (100% and 83.6% respectively, p = 0.001). Interval time from diagnostic CT scan to surgery and from MDT decision to treat to surgery was shorter in the FT group, (median 8 vs 43 days p < 0.001 and 3 vs 36 days p < 0.001 respectively) as was the overall time from diagnostic CT to adjuvant treatment (88 vs 121 days p < 0.001). Postoperative outcomes including complications, readmission and mortality rates were comparable in the two groups. There was no difference in survival. CONCLUSION: For a person with pancreatic cancer who is proceeding to surgery, the best approach is to avoid pre-operative biliary drainage.

Review of minimally invasive pancreas surgery and opinion on its incorporation into low volume and resource poor centres.

Pancreatic surgery has been one of the last areas for the application of minimally invasive surgery (MIS) because there are many factors that make laparoscopic pancreas resections difficult. The concept of service centralization has also limited expertise to a small cadre of high-volume centres in resource rich countries. However, this is not the environment that many surgeons in developing countries work in. These patients often do not have the opportunity to travel to high volume centres for care. Therefore, we sought to review the existing data on MIS for the pancreas and to discuss. In this paper, we review the evolution of MIS on the pancreas and discuss the incorporation of this service into low-volume and resource-poor countries, such as those in the Caribbean. This paper has two parts. First, we performed a literature review evaluating all studies published on laparoscopic and robotic surgery of the pancreas. The data in the Caribbean is examined and we discuss tips for incorporating this operation into resource poor hospital practice. Low pancreatic case volume in the Caribbean, and financial barriers to MIS in general, laparoscopic distal pancreatectomy, enucleation and cystogastrostomy are feasible operations to integrate in to a resource-limited healthcare environment. This is because they can be performed with minimal to no consumables and require an intermediate MIS skillset to complement an open pancreatic surgeon's peri-operative experience.

Surgical relevance of anatomic variations of the right hepatic vein.

BACKGROUND: Variations in the anatomy of hepatic veins are of interest to transplant surgeons, interventional radiologists, and other medical practitioners who treat liver diseases. The drainage patterns of the right hepatic veins (RHVs) are particularly relevant to transplantation services. AIM: The aim was to identify variations of the patterns of venous drainage from the right side of the liver. To the best of our knowledge, there have been no reports on RHV variations in in a Caribbean population. METHODS: Two radiologists independently reviewed 230 contrast-enhanced computed tomography scans performed in 1 year at a hepatobiliary referral center. Venous outflow patterns were observed and RHV variants were described as: (1) Tributaries of the RHV; (2) Variations at the hepatocaval junction (HCJ); and (3) Accessory RHVs. RESULTS: A total of 118 scans met the inclusion criteria. Only 39% of the scans found conventional anatomy of the main hepatic veins. Accessory RHVs were present 49.2% and included a well-defined inferior RHV draining segment VI (45%) and a middle RHV (4%). At the HCJ, 83 of the 118 (70.3%) had a superior RHV that received no tributaries within 1 cm of the junction (Nakamura and Tsuzuki type I). In 35 individuals (29.7%) there was a short superior RHV with at least one variant tributary. According to the Nakamura and Tsuzuki classification, there were 24 type II variants (20.3%), six type III variants (5.1%) and, five type IV variants (4.2%). CONCLUSION: There was significant variation in RHV patterns in this population, each with important relevance to liver surgery. Interventional radiologists and hepatobiliary surgeons practicing in the Caribbean must be cognizant of these differences in order to minimize morbidity during invasive procedures.

Can the postoperative follow-up visit be deferred up to four weeks after an uneventful cataract surgery? - A randomized controlled trial.

Purpose: The aim of this study was to compare the postoperative visual outcome after a Day 0 examination in patients with two follow-ups, one between Day 3 to Day 7 and other between Day 25 to Day 30 to those with a single ophthalmic follow-up directly after 25-30 Days and to assess the safety of deferral of the first follow-up visit at 1 week. Methods: Randomized Controlled Trial was conducted at a tertiary eye care hospital, with 848 patients enrolled for the study. Patients meeting the inclusion criteria were selected. Their pre-operative and post-operative data was collected and the patients were divided into groups based on the type of cataract surgery and the postoperative follow-up protocol through randomization. Results: No significant difference was observed in the postoperative visual outcome in patients that underwent postoperative review at Day 3-7 and Day 25-30 as opposed to those that followed up directly at Day 25-30 after a mandatory Day 0 examination for all patients. Conclusion: In patients with no preexisting ocular or systemic comorbidity undergoing an uneventful cataract surgery, the postoperative follow-up visit can be safely deferred until 4 weeks, without any impact on the postoperative visual outcome, thereby conserving the available resources which can be deviated towards better eye care services.

Post hepatectomy liver failure (PHLF) - Recent advances in prevention and clinical management.

BACKGROUND: Posthepatectomy liver failure (PHLF) is a relatively rare but feared complication following liver surgery, and associated with high morbidity, mortality and cost implications. Significant advances have been made in detailed preoperative assessment, particularly of the liver function in an attempt to predict and mitigate this complication. METHODS: A detailed search of PubMed and Medline was performed using keywords "liver failure", "liver insufficiency", "liver resection", "postoperative", and "post-hepatectomy". Only full texts published in English were considered. Particular emphasis was placed on literature published after 2015. A formal systematic review was not found feasible hence a pragmatic review was performed. RESULTS: The reported incidence of PHLF varies widely in reported literature due to a historical absence of a universal definition. Incorporation of the now accepted definition and grading of PHLF would suggest the incidence to be between 8 and 12%. Major risk factors include background liver disease, extent of resection and intraoperative course. The vast majority of mortality associated with PHLF is related to sepsis, organ failure and cerebral events. Despite multiple attempts, there has been little progress in the definitive and specific management of liver failure. This review article discusses recent advances made in detailed preoperative evaluation of liver function and evidence-based targeted approach to managing PHLF. CONCLUSION: PHLF remains a major cause of mortality following liver resection. In absence of a specific remedy, the best approach is mitigating the risk of it happening by detailed assessment of liver function, patient selection and general care of a critically ill patient.

Management of ocular surface squamous neoplasia extending up to a filtering trabeculectomy bleb.

A 73-year-old-gentleman was referred for ocular surface squamous neoplasia (OSSN) in his right eye (RE). He had history of combined cataract with trabeculectomy in RE and was maintaining his intraocular pressure (IOP). He showed a corneoscleral lesion measuring 11 × 8 mm in nasal quadrant wherein, the superior edge of the lesion was extending up to the filtering bleb. After ruling out intraocular invasion or regional spread, he underwent complete tumor excision with "no touch" technique along with cryotherapy and surface reconstruction and a perilesional injection of Interferon α2B. At 6-month visit, he shows no locoregional recurrence and has controlled IOP.

Evaluation of skills transfer in short-term phacoemulsification surgery training program by International Council of Ophthalmology -Ophthalmology Surgical Competency Assessment Rubrics (ICO-OSCAR) and assessment of efficacy of ICO-OSCAR for objective evaluation of skills transfer.

Purpose: To evaluate skills transfer in short-term phacoemulsification surgery training program by International Council of Ophthalmology -Ophthalmology Surgical Competency Assessment Rubrics (ICO-OSCAR) and assessment of efficacy of ICO-OSCAR for objective evaluation of skills transfer. Methods: Prospective analysis of total 1300 phacoemulsification surgeries performed by 52 phacoemulsification trainees divided into three groups based on the previous cataract surgical experience. The pretraining and posttraining average mean scores, independent completion rates (ICR), and complication rates among the groups were calculated and statistically analyzed. Results: Mean age of trainees (N = 52) was found to be 30.98 ± 2.44 years. Mean pretraining scores in the three groups were 42.8 ± 0.2, 46.6 ± 0.2, and 50.1 ± 0.1, respectively, and posttraining mean scores of the groups were 88.4 ± 0.2, 92.3 ± 0.2, and 94.3 ± 0.2, respectively, out of 100. Pretraining independent completion rates (%) were 22.1 ± 2.5, 52.1 ± 2.5, and 62 ± 3.7, respectively, and posttraining independent completion rates (%) were 74.8 ± 3, 79.7 ± 3, and 90.6 ± 3.5, respectively. Learning curves of all groups were noted to be steep. Rate of complications was within acceptable range, overall complication rate being 12.30% (160 out of 1300 cases). OSCAR scores correlate significantly (P = 0.0004) with ICR. Conclusion: Steep learning curve for phacoemulsification can be made easy by the use of standardized rubrics, proper techniques, expert guidance, and adequate surgical volume. The previous SICS experience provides smoother learning curve. ICO-OSCAR is indicator of proficiency and provides constructive feedback and objective evaluation immediately after surgery as well as at the end of training. Short-term (1 Month) training program is an effective, efficient, and safe approach to progressively master phacoemulsification skills for trainees with SICS experience.

Loss of CLN3, the gene mutated in juvenile neuronal ceroid lipofuscinosis, leads to metabolic impairment and autophagy induction in retinal pigment epithelium.

Juvenile neuronal ceroid lipofuscinosis (JNCL, aka. juvenile Batten disease or CLN3 disease) is a lysosomal storage disease characterized by progressive blindness, seizures, cognitive and motor failures, and premature death. JNCL is caused by mutations in the Ceroid Lipofuscinosis, Neuronal 3 (CLN3) gene, whose function is unclear. Although traditionally considered a neurodegenerative disease, CLN3 disease displays eye-specific effects: Vision loss not only is often one of the earliest symptoms of JNCL, but also has been reported in non-syndromic CLN3 disease. Here we described the roles of CLN3 protein in maintaining healthy retinal pigment epithelium (RPE) and normal vision. Using electroretinogram, fundoscopy and microscopy, we showed impaired visual function, retinal autofluorescent lesions, and RPE disintegration and metaplasia/hyperplasia in a Cln3 ~ 1 kb-deletion mouse model [1] on C57BL/6J background. Utilizing a combination of biochemical analyses, RNA-Seq, Seahorse XF bioenergetic analysis, and Stable Isotope Resolved Metabolomics (SIRM), we further demonstrated that loss of CLN3 increased autophagic flux, suppressed mTORC1 and Akt activities, enhanced AMPK activity, and up-regulated gene expression of the autophagy-lysosomal system in RPE-1 cells, suggesting autophagy induction. This CLN3 deficiency induced autophagy induction coincided with decreased mitochondrial oxygen consumption, glycolysis, the tricarboxylic acid (TCA) cycle, and ATP production. We also reported for the first time that loss of CLN3 led to glycogen accumulation despite of impaired glycogen synthesis. Our comprehensive analyses shed light on how loss of CLN3 affect autophagy and metabolism. This work suggests possible links among metabolic impairment, autophagy induction and lysosomal storage, as well as between RPE atrophy/degeneration and vision loss in JNCL.

Eyelid Lesion as a Presenting Sign of Pancreatic Adenocarcinoma.

Eyelid metastases are relatively rare, and they can occasionally lead the way to an unknown primary malignancy elsewhere. The authors report a case of 65-year-old diabetic gentleman with a right-sided eyelid lesion that was present for 1 month and turned out to be a presenting sign of a previously undiagnosed pancreatic adenocarcinoma. The eyelid mass had been treated elsewhere for 2 weeks for a presumed infectious lesion, using systemic antibiotics and was then referred to us in view of no response. The right-sided lesion involving the subbrow and eyelid area was tender and showed surface ulceration, as well as induration with scabbing. An incision biopsy of the mass was performed followed by computed tomography imaging. Histopathologic findings were suggestive of adenocarcinoma of a probable secondary origin. A whole-body positron emission tomography (PET) scan along with raised serum tumor markers (carcinoembryonic antigen 125 [CEA 125] and carbohydrate antigen 19-9 [CA-19-9]) was helpful in diagnosing a stage IV probable primary carcinoma of the pancreas, with metastasis to paraaortic nodes, liver, lungs, and eyelid. After a detailed systemic work-up, the patient was put on systemic chemotherapy with carboplatin and capacitabane. He responded well to the treatment. At a follow up of 12 months, upon clinical examination and PET imaging, he showed a complete resolution of eyelid, lung, and liver disease and a near-complete resolution of the pancreatic lesion. This case delineates the role of a prompt biopsy and histopathologic evaluation of an atypical eyelid mass in diagnosing asymptomatic primary malignancy.

The Influence of Patients' Age on the Outcome of Treatment for Pancreatic Ductal Adenocarcinoma.

OBJECTIVE: The aim of the study was to determine the impact of age on curative management and outcomes of patients with pancreatic ductal adenocarcinoma. METHODS: Patients who underwent resection for pancreatic ductal adenocarcinoma at 2 units were retrospectively reviewed (between 2005 and 2017) and stratified by age (older patients ≥70 years). Regression analysis was used to explore factors impacting administration of adjuvant chemotherapy and survival. The Kaplan-Meier method was used to estimate overall survival (time from surgery to death). Statistical significance was set at P < 0.05. RESULTS: From 2005 to 2014, 222 patients were identified (<70 years, n = 128; ≥70 years, n = 94). Elderly patients were less likely to receive adjuvant chemotherapy compared with younger patients (odds ratio, 0.57, P = 0.041). Tumor stage, margin, and year of surgery (post-2011 vs pre-2011) were not predictors for chemotherapy receipt (P > 0.05). Frailty was the commonest reason (36.8%) to decline chemotherapy in elderly patients. In patients receiving adjuvant chemotherapy, completion rates (P = 0.32) and overall survival (24 months vs 30 months, P = 0.50) were no different. CONCLUSIONS: Elderly patients demonstrate similar outcomes to younger yet are less likely to commence chemotherapy because of frailty. Holistic preoperative assessment may improve selection for curative treatment.

PROCalcitonin-based algorithm for antibiotic use in Acute Pancreatitis (PROCAP): study protocol for a randomised controlled trial.

BACKGROUND: Differentiating infection from inflammation in acute pancreatitis is difficult, leading to overuse of antibiotics. Procalcitonin (PCT) measurement is a means of distinguishing infection from inflammation as levels rise rapidly in response to a pro-inflammatory stimulus of bacterial origin and normally fall after successful treatment. Algorithms based on PCT measurement can differentiate bacterial sepsis from a systemic inflammatory response. The PROCalcitonin-based algorithm for antibiotic use in Acute Pancreatitis (PROCAP) trial tests the hypothesis that a PCT-based algorithm to guide initiation, continuation and discontinuation of antibiotics will lead to reduced antibiotic use in patients with acute pancreatitis and without an adverse effect on outcome. METHODS: This is a single-centre, randomised, controlled, single-blind, two-arm pragmatic clinical and cost-effectiveness trial. Patients with a clinical diagnosis of acute pancreatitis will be allocated on a 1:1 basis to intervention or standard care. Intervention will involve the use of a PCT-based algorithm to guide antibiotic use. The primary outcome measure will be the binary outcome of antibiotic use during index admission. Secondary outcome measures include: safety non-inferiority endpoint all-cause mortality; days of antibiotic use; clinical infections; new isolates of multiresistant bacteria; duration of inpatient stay; episode-related mortality and cause; quality of life (EuroQol EQ-5D); and cost analysis. A 20% absolute change in antibiotic use would be a clinically important difference. A study with 80% power and 5% significance (two-sided) would require 97 patients in each arm (194 patients in total): the study will aim to recruit 200 patients. Analysis will follow intention-to-treat principles. DISCUSSION: When complete, PROCAP will be the largest randomised trial of the use of a PCT algorithm to guide initiation, continuation and cessation of antibiotics in acute pancreatitis. PROCAP is the only randomised trial to date to compare standard care of acute pancreatitis as defined by the International Association of Pancreatology/American Pancreatic Association guidelines to patients having standard care but with all antibiotic prescribing decisions based on PCT measurement. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number, ISRCTN50584992. Registered on 7 February 2018.