Guidelines for the Management of Upper Gastrointestinal Bleeding

Guidelines for the Management of Upper Gastrointestinal Bleeding Nasser Ahmed A- Harhra – MD Surgery Consultant Surgeon - Associate Professor of Surgery Guidlines UGIT Bleeding - Dr. 1

Background : The management of patients with acute upper gastrointestinal bleeding has evolved worldwide substantially over the past 10 years amid a paucity and absence of local consensus guidelines. Purpose : To provide evidence-based management recommendations that address clinically relevant issues for these patients in our hospital. Guidlines UGIT Bleeding - Dr. 2

Determination of Need for Guidelines : The need for clinical practice guidelines on the management of patients with upper GI bleeding was identified worldwide by different systems , hospitals and GIT units. Review of the existing literature and the current local situation will guide to recommendations to the management of UGI bleeding in our hospital. Guidlines UGIT Bleeding - Dr. 3

What is a guideline ? It is meant to be a guide for clinical practice , based on the best available evidence at the time of development. Adherence to these guidelines may not necessarily ensure the best outcome in every case. Every health care provider is responsible for the management of his/her unique patient based on the clinical picture presented by the patient and the management options available locally. Review of the Guidelines : The guideline is issued and reviewed periodically according to the outcome or sooner if new evidence becomes available Guidlines UGIT Bleeding - Dr. 4

Validity and grading of recommendations These guidelines have been produced to conform to the system proposed by a specialized professional unit ( eg : British Society of Gastroenterology by North of England evidence based guidelines development project ). CATEGORIES OF EVIDENCE as follows: Gra Ia: evidence obtained from meta-analysis of randomised trials. Gra Ib: evidence obtained from at least one randomised trial. Gra IIa: evidence obtained from at least one well designed controlled study without randomisation. Gra IIb: evidence obtained from at least one other type of well designed quasi experimental study. Gra III: evidence obtained from well designed non-experimental descriptive studies such as comparative studies, correlation studies, and case studies. Gra IV: evidence obtained from expert committee reports, or opinions or clinical experiences of respected authorities. Guidlines UGIT Bleeding - Dr. 5

The current guidelines are a consensus paper with multisociety representation by The Canadian Registry in Upper Gastrointestinal Bleeding and Endoscopy(RUGBE) General Organization A 2 -day consensus conference was held in June 2002 under the auspices of the Canadian Association of Gastroenterology. The conference was conducted according to generally accepted standards for the development of clinical practice guidelines. At the consensus conference, data were presented and the statements and the grades attributed to evidence were discussed, modified if necessary, and voted on by each participant according to the recognized criteria Categorization of Evidence, Classification of Recommendations, and Voting Schema Category and Grade Description Guidlines UGIT Bleeding - Dr. 6

Quality of evidence I Evidence obtained from at least 1 properly randomized, controlled trial. II-1 Evidence obtained from well-designed controlled trials without ndomization. II-2 Evidence obtained from well-designed cohort or case– control analytic studies, preferably from more than 1 center or research group. II-3 Evidence obtained from comparisons between times or places with or without the intervention, or dramatic results in uncontrolled experiments. III Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees. Guidlines UGIT Bleeding - Dr. 7

Classification of recommendations A There is good evidence to support the procedure or treatment. B There is fair evidence to support the procedure or treatment. C There is poor evidence to support the procedure or treatment, but recommendations may be made on other grounds. D There is fair evidence that the procedure or treatment should not be used. E There is good evidence that the procedure or treatment should not be used. Voting on the recommendations* a Accept completely. b Accept with some reservation. c Accept with major reservation. d Reject with reservation. e Reject completely. • Statements for which more than 50% of participants voted a, b, or c were accepted. Guidlines UGIT 8 Bleeding - Dr.

It is reported that , mortality is found to be lower in specialist units and this is probably not related to technical developments but because of adherence to protocols and guidelines. Thus guidelines do have the potential * To improve prognosis * In addition may be of value in making the best use of resources by fast tracking low risk patients , * thereby optimizing duration of hospital stay. What is the problem ? Guidlines UGIT Bleeding - Dr. 9

Worldwide : Epidemiology : incidence ranging 50 – 100 per 100 000 / year Etiology : Peptic ulcer disease 35 – 50 % liver cirrhosis and portal hypertension ( Alcohol ) 5 – 10 % ( High risk patients : old , coagulopathies and impaired liver Function ) Significant improvements in patient assessment and management have reduced : Guidlines UGIT the mortality from 10 -40 % to 5 %. Bleeding - Dr. 10

In yemeni Local Studies ¡ ¡ : ( Hati , Al-Nawi , and Karama ( J of Nat and App Science - University of Aden ; 2001 ) -- Ben Silm (Yemeni J of Med & Health Res 2003 ) &Amin Abdu-Elrub et al , Sana` ( Yemen Medical J ; 2002 ). Incidence : ? ? Mortality : ? One study : The overall mortality was 24% and bleeding esophageal varices were the major causes of death , in 230 patients. (Amin ; 2002 ). In all : Port. hypertension is the commonest cause 60 – 70 % - ( Mostly due to periportal fibrosis of Schistosomiasis and cirrhosis due to viral hepatitis B & C ). Patients are mostly young and have good , reserved hepatic function. Peptic ulcer disease : 25 – 40 % Guidlines UGIT 11 Bleeding - Dr.

Critical care Units ( ICU , HDU , CCU ect. . ) Endoscopy Unit Gastroenterology Unit Specialized centers , hospitals , ……ect An agreed protocol for the management of UGIT bleeding should be distributed to all medical and nursing staff who care for such patients. This includes medical, geriatric, and surgical wards, the admission unit, laboratories, and pharmacy. Guidlines UGIT 12 Bleeding - Dr.

+ UK guidelines on the management of variceal haemorrhage in cirrhotic patients - R Jalan , P C Hayes : Gut 2000 ; 46(Suppl 3): iii 1 -iii 15 ( June ) + Consensus Recommendations for Managing Patients with Nonvariceal Upper Gastrointestinal Bleeding – Alan Barkun et al ; Ann Intern Med. 2003; 139: 843 -857. www. annals. org + Review : Non-variceal upper gastrointestinal bleeding – CB Ferguson, RM Mitchell - www. ums. ac. uk Ulster Med J 2006; 75 (1) 32 -39 + Leeds General Infirmary Guidelines – February 2002 + Rockall TA et al Gut 1996; 38: 316 -21 Guidlines UGIT + Vreeburg EM et al Gut 1999; 44: 331 -5 Bleeding - Dr. 13

+ The Victorian Surgical Consultative Council Guidelines for the Management of Upper Gastrointestinal Bleeding Dr Simon Travis DPhil and Dr Dermot Mc. Govern John Radcliffe Hospital, Oxford – 2006 + British Society of Gastroenterology Endoscopy Committee. Nonvariceal upper gastrointestinal hemorrhage: guidelines , Gut. 2002; 51 (Suppl 4): iv 1 -6. www. gutjnl. com + CLINICAL PRACTICE GUIDELINES , April 2003 – MANAGEMENT OF NON-VARICEAL UPPERGASTROINTESTINAL BLEEDING MALAYSIAN SOCIETY of GASTROENTEROLOGY AND HEPATOLOGY ACADEMY OF MEDICINE MALAYSIA http: // www. moh. gov. my/medical/htm or : http: // www. acadmed. org. my Guidlines UGIT Bleeding - Dr. 14

®UGIB remains a common and challenging emergency for gastroenterologists and general physicians. ® The annual incidence is 50 to 150 per 100, 000 of the population, and , even though there have been significant improvements in endoscopic and supportive therapies ® Overall mortality around 10% , and even reach 35% in hospitalised patients with serious comorbidity. Patients aged over 80 years of age now account for around 25% of all UGIB and 33% of UGIB occurring in hospitalized patients with the poor outcome of this condition Guidlines UGIT Bleeding - Dr. 15

®The commonest cause of UGIB is peptic ulcer disease ( 50 -60 %) and then mucosal erosive diseases at 12 -20%. In a recent large (CORI )study of UGIB, peptic ulcer was the probable cause of UGIB in only 20% of cases. The incidence is expected to continue to decline with more widespread helicobacter pylori eradication and PPI usage. Gastrointest Endosc 2004; 9(7): 788 -94. ® Factors commonly associated with poor outcome from UGIB may be related to the patient’s presentation and comorbidities, or to the behaviour of the pathologic cause ® RISK ASSESSMENT AND INITIAL MANAGEMENT : Several clinical scoring systems e. g. Rockall score, the Baylor bleeding score, the Cedars Sinai M C Pre. Index and the Blatchford score, developed to direct appropriate patient management and enable cost effective use of resources. These weigh a combination of clinical, laboratory and endoscopic variables to produce a score that predicts the risk of mortality, recurrent haemorrhage, need for intervention or Guidlines UGIT 16 suitability for early discharge. Bleeding - Dr.

Risk Factors For Death After Hospital Admission For Acute Upper Gastrointestinal Bleeding 1. Advanced age 2. Shock on admission (pulse rate >100 beats/min; systolic blood pressure < 100 mm. Hg) 3. Comorbidity (particularly hepatic or renal failure and disseminated malignancy) 4. Diagnosis (worst prognosis for advanced upper gastrointestinal malignancy) 5. Endoscopic findings (active, spurting haemorrhage from peptic ulcer; non-bleeding visible vessel) 6. Rebleeding (increases mortality 10 fold) Rockall TA, Logan RFA, Devlin HB, et al. Risk assessment after acute upper gastrointestinal haemorrhage. Gut 1996; 38: 316 -321 Mortality is low in patients below 40 years of age but increases steeply thereafter. Patients with severe comorbidity, particularly renal failure, liver failure and disseminated malignancy have a poor prognosis (Grade A). Guidlines UGIT Bleeding - Dr. 17

Rockall Score • Initial Rockall Score • Age <60 years 0 • 60 -79 yrs 1 • >80 yrs 2 • Shock • None 0 • Pulse>100 & • Syst BP>100 1 • Syst BP<100 2 • Co-morbidity • None 0 • Cardiac failure, IHD or any • major co-morbidity 2 • Renal/liver failure, or • dissem. malignancy 3 Initial R-sc (Max score 7) Guidlines UGIT Bleeding - Dr. • • • Full score after OGD Endoscopic diagnosis M-W tear*, no lesion seen and no SRH* 0 All other diagnoses 1 Malignancy of upper GI tract 2 Major SRH* None or dark spot only 0 Blood in upper GI tract, adherent clot, visible or Spurting vessel 2 Final R- score(Max score 11) 18

In the Rockall risk assessment score, a series of independent risk factors were scored. Patients who score 2 or less have a mortality of 0. 1% and a rebleeding rate of 4. 3% score in excess of 8 is associated with a 41% mortality and rebleeding rate of 42. 1%. The score was more reliable in predicting mortality than it was in predicting rebleeding (Grade A). Such risk assessment scores may be useful in triaging patients for either outpatient care or admission to an high dependency unit ® Inclusion of endoscopic stigmata of recent haemorrhage (SRH) that relate to increased risk of re-bleeding and death into scoring systems increases the sensitivity for predicting patients at high or low risk compared to non-endoscopic assessments. Guidlines UGIT Bleeding - Dr. 19

® Endoscopic intervention reduces the rate of re-bleeding, need for surgical intervention and mortality in high risk patients. The optimum timing of endoscopy remains a balance between clinical need and resources, but endoscopy performed within 24 hours of admission has been shown to reduce the length of hospital stay and may reduce likelihood of rebleeding or surgical intervention in the highest risk pats. Rebleeding occurs in 55% of patients who have active bleeding (pulsatile, oozing), in 43% who have a nonbleeding visible vessel, in 22% who have an ulcer with an adherent clot, and in 0 – 5% who have an ulcer with a clean base. At endoscopy, the prevalence rate for a clean base is 42%, for a flat spot is 20%, for an adherent clot is 17%, for a visible vessel is 17%, and for active bleeding is 18%. Guidlines UGIT Bleeding - Dr. 20

Forrest classification of peptic ulcers in UGIB Forrest class Type of lesion Risk of rebleed if untreated [%] Ia Arterial spurting 100 Ib Arterial oozing 17 -100 IIa Visible vessel 8 -81 IIb Sentinel clot 14 -36 IIc Haematin covered flat spot 0 -13 III No stigmata 0 -10 SRH=Stigmata of recent haemorrhage. Major SRH=Forrest 1 a, 1 b, 2 a and 2 b. Minor SRH=Forrest 2 c and 3. Risk Assessment : Endoscopic findings of active, spurting haemorrhage and a non-bleeding visible vessel within an ulcer are associated with a definite risk of rebleeding. The absence of these stigmata, varices or upper GIT cancer indicates a low risk of rebleeding (Grade A). Guidlines UGIT 21 Bleeding - Dr.

Endoscopic Treatment For Non-variceal UGI Bleeding Thermal · Heater probe · Multipolar electrocoagulation (BICAP, Gold Probe) · Argon plasma coagulation · Laser Injection · Adrenaline (1: 10000) · Procoagulants(fibrin glue, human thrombin) · Sclerosants (ethanolamine, 1% polidoconal) · Alcohol (98%) Mechanical · Clips · Band Ligation · Endoloops · Staples Guidlines UGIT · Sutures Bleeding - Dr. Combination therapy. Injection plus thermal therapy · Injection plus mechanical therapy 22

A combination of therapies has become more common. Injection therapy is applied first to better clarify the bleeding site, especially in the actively bleeding patient; then, heater probe or bipolar (gold) probe coagulation is applied. Injection therapy can also be performed prior to endoscopic placement of hemoclips. Injection therapy is useful prior to laser therapy to reduce the heat sink effect of rapidly flowing blood prior to laser coagulation BALLOON TAMPONADE : This form of treatment is highly effective and controls acute bleeding in up to 90% of patients although about 50% rebleed when the balloon is deflated. It is , however, associated with serious complications such as oesophageal ulceration and aspiration pneumonia in up to 1520% of patients. Despite this, it may be a life saving treatment in cases of massive uncontrolled variceal haemorrhage pending Guidlines UGIT 23 other forms of treatment. Bleeding - Dr.

PHARMACOLOGICAL THERAPY : The use of H 2 antagonists in upper gastrointestinal bleeding is not recommended (Grade A). A meta-analysis of randomised trials It is recommended that following endoscopic therapy in major peptic ulcer bleeding, high dose intravenous PPI (eg IV Omeprazole 80 mg stat followed by an infusion of 8 mg hourly for 72 hours) be commenced (Grade B) Somatostatin : High dose IV somatostatin suppresses acid secretion and reduces sphanchnic blood flow. A metaanalysis showed benefit for treated patients (grade A) but the quality of most of the individual trials is poor and currently there are insufficient data to advocate routine use of this drug in patients with nonvariceal UGIB bleeding. Guidlines UGIT Bleeding - Dr. 24

• Vasopressin (either alone or in combination with nitroglycerine) and Octretide ( somatostatin analogue ) are valuable vasoactive drugs that are used in the treatment of bleeders with portal hypertension. Glypressin is a synthetic analogue of vasopressin and is found to be equally effective Antifibrinolytic drugs. A meta-analysis has shown that tranexamic acid therapy, while not reducing ulcer rebleeding , does appear to reduce the need for surgical intervention and tends to reduce mortality in ulcer bleeding patients. Guidlines UGIT Bleeding - Dr. 25

• It is found in control of bleeding in esophageal vaices that : Variceal band ligation is the method of first choice. (Recommendation grade AI. ) If banding is difficult because of continued bleeding or this technique is not available, endoscopic variceal sclerotherapy should be performed. (Recommendation grade AI. ) If endoscopy is unavailable, vasoconstrictors such as octreotide or glypressin, or a Sengstaken tube inserted (with adequate provision for airways protection) may be used while more definitive therapy is arranged. (Recommendation grade AI Guidlines UGIT Bleeding - Dr. 26

Philosophy of Surgical Management ©The general philosophy is that saving lives, i. e. stopping the bleeding, comes first. This is the main consideration in the severely ill patients. © The role of surgery has changed with wider use of endoscopic hemostasis in bleeding ulcers, no longer aiming to cure the disease but primarily to stop the hemorrhage. © In the less compromised subjects, the secondary issue of long-term cure of disease may be considered. But now, when such a goal can be achieved by medical means, the role of definitive anti-ulcer procedures is limited and should be considered only in well-selected patients: those expected to be not compliant with medications and in situations where such medications are not readily available. Guidlines UGIT Bleeding - Dr. 27

Indications for Surgery as the Primary Mode of Treatment : The rate of primary-emergency surgery varies depending on the case mix and the expertise of endoscopic management. Thus the surgeon should be involved from the outset in the team caring for the patient early and close cooperation between endoscopists/gastroenterologists and surgeons is vital. 1. Massive bleeding Uncontrolled massive bleeding by endoscopic procedures. This may be due to bleeding that is unresponsive to endoscopic hemostasis or failure of endoscopic visualization of the bleeder due to profuse hemorrhage. A continued attempt with endoscopic treatment is futile and dangerous. 2. Ulcer inaccessible to endoscopic control This can occur in duodenums that are often deformed and narrowed. Primary surgery is indicated in such circumstances. Guidlines UGIT Bleeding - Dr. 28

Type of Surgery for Bleeding Peptic Ulcer There appears to be no difference between local (underrunning/ over-sewing or excision of ulcer) and radical surgery (gastric resection or vagotomy) with respect to mortality although rebleeding rate may be higher in the local group Currently it is not possible to make definite recommendations in the absence of any good prospective randomized trials. The magnitude of surgery should be tailored to the type of ulcer, severity of illness in the patient and experience of the surgeon. © The source of bleeding is always at the base of a posterior ulcer. Hemostasis is accomplished through an anterior duodenotomy, underrunning the base (and bleeding vessel) with two or three (2 -0 monofilament) deeply placed sutures each placed on a different axis. Guidlines UGIT Bleeding - Dr. 29

If the patient is in good shape and requires a definitive procedure , other options are : © Truncal vagotomy (TV), extending the duodenotomy across the pylorus, and closing it to form a Heinke-Mikulicz pyloroplasty. © In a fit and stable patient, close the duodenotomy and perform a highly selective vagotomy (HSV), adding an hour or so to the procedure. © The proponents of antrectomy plus vagotomy for bleeding DUs claim an increased incidence of re-hemorrhage when gastric resection is avoided Traditionally, a bleeding Gastric Ulcer mandated a partial gastrectomy. Gastric resection is indeed effective in controlling the hemorrhage, but in most instances represents a superfluous ritual. For acute-superficial ulcers all that is required is simple underrunning of the lesion through a small gastrotomy. In fact, in most patients who bleed from a chronic GU, simple underrunning of the ulcer from within, through a gastrotomy, suffices Guidlines UGIT 30 Bleeding - Dr.

Type I is the classical lesser curvature GU. Billroth I partial gastrectomy. An HSV (from the ulcer proximally) plus the excision of the ulcer (from inside the stomach) is the alternative. Type II is a pre-pyloric ulcer- between DU and GU – antrectomy plus vagotomy are popular, excellent results are achieved with HSV plus pyloroplasty. Type III is a combination of a GU and a DU: it should be treated as type 11. Type IV implies a high, juxta-cardial lesser curvature GU. Prior to the days of effective anti-ulcer medication, partial gastrectomy – distal to the ulcer - was the procedure of choice. Since the entire lesser curvature may be obliterated, HSV is usually impossible - making TV plus a drainage procedure a reasonable alternative. Guidlines UGIT Bleeding - Dr. 31

AFTER CARE After the initial endoscopy and the institution of endoscopic therapeutic measures where necessary, the key point in the aftercare is the recognition of patients at high risk of rebleeding and death who would require careful monitoring in an intensive care or high dependency setting. Predictors of an increased risk of rebleeding and death (as well as failure of endoscopic therapy) include (i) clinical factors such as shock at the time of presentation, advanced age, co-existing illnesses, (ii) endoscopic features such as ulcer location (posterior duodenal ulcer) , size of the ulcer (>2 cm) , stigmata of recent haemorrhage and the presence of blood at the time of endoscopy as well as (iii) laboratory features such as haemoglobin (<10 g/dl) and elevated blood urea levels Guidlines UGIT Bleeding - Dr. 32

Rebleeding After Initial Endosc. Control of Bleed Ulcers : The major challenge in applying endoscopic therapy for bleeding peptic ulcers is that haemostasis is not permanent and re-bleeding occurs in about 15 -20% of the cases. Endoscopic treatment would avoid the surgical risk. However, delay in establishing haemostasis may result in hypotension and adversely affect the survival. In patients with peptic ulcers and recurrent bleeding after initial endoscopic control of bleeding , endoscopic retreatment reduces the need for surgery without increasing the risk of death and is associated with fewer complications than is surgery (Grade A). Guidlines UGIT Bleeding - Dr. 33

1. To establish local guidelines for management of these high risky patients according to the available resources in the hospital. 2. Establish a system : Team approach of these risky patients within the same unit and between medico-surgical units Clinical assessment of severity and risk Medical treatment especially in patients with esophageal varices Discuss and enhance the role of surgery in these patients especially in stable emergency patients ( child`s A +/_ B ) , young and fit patients , and patients with schistosomiasis. Guidlines UGIT Bleeding - Dr. 34

3. The hospital : To Support the role of emergency and ICU units Discuss the possibility of foundation of Gastroenterology Unit in the hospital To Support the role of endoscopy department in the hospital The proper registration of cases in the health center and hospitals 4. To stimulate the research and documentation of the experience of post graduates and senior surgeons about this disease Guidlines UGIT Bleeding - Dr. 35

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