What are the guideline sources, guidelines and references for Gallbladder cancer ?
Guideline sources The following summarized guidelines for the evaluation and management of gallbladder cancer are prepared by our editorial team based on guidelines from the Enhanced Recovery After Surgery Society (ERASS 2023), the European Society of Medical Oncology (ESMO 2023; 2016), the Society for Immunotherapy of Cancer (SITC 2023), the European Association for the Study of the Liver (EASL 2022), the American Society for Gastrointestinal Endoscopy (ASGE 2021), the American Society of Clinical Oncology (ASCO 2019), and the American College of Radiology (ACR 2019). 1 2 4 5 6 7 8 9 10 Guidelines 1. Screening and diagnosis Indications for screening: https://web.pathway.md/diseases/rec7AzQA8CnJmT9L8 1/7 6/24/23, 2:54 AM Gallbladder cancer Pathway As per EASL 2022 guidelines, consider obtaining screening for gallbladder cancer with ultrasound and/or MRI/MRCP at least annually in patients with large-duct PSC, regardless of disease stage. C As per ESMO 2016 guidelines, consider obtaining screening for biliary cancer only in at-risk patients, such as patients with PSC. E 2. Classification and risk stratification Staging: As per ESMO 2023 guidelines, classify biliary tract cancer according to the International Classification of Diseases-11 criteria. B Show 3 more As per ESMO 2016 guidelines: Consider obtaining EUS, with or without nodal biopsy, to clarify N-stage and to acquire information regarding vessel involvement. E Consider performing staging laparoscopy on an individual basis to exclude the presence of peritoneal metastases, if it will influence the decision to proceed with major resection. E Prognosis: recognize that elevated CA19-9 is associated with poorer prognosis. B 3. Diagnostic investigations Diagnostic imaging: As per ESMO 2023 guidelines, obtain radiological imaging before ERCP or percutaneous transhepatic cholangiography in patients with jaundice. B As per ESMO 2016 guidelines, consider obtaining abdominal ultrasound for initial evaluation (identification of biliary obstruction). E Show 2 more 4. Diagnostic procedures Biopsy and histopathology: As per ESMO 2023 guidelines, perform a core biopsy for diagnostic pathology and molecular profiling before any nonsurgical treatment. B Show 2 more As per ESMO 2016 guidelines: Follow standardized reporting tools (minimum dataset) for pathology examination and reporting of surgically-resected specimens. E Report the size and number of tumors, grade, the presence of satellite nodules, and vascular and/or perineural invasion to guide decisions regarding adjuvant therapy. B https://web.pathway.md/diseases/rec7AzQA8CnJmT9L8 2/7 6/24/23, 2:54 AM Gallbladder cancer Pathway 5. Medical management General principles: Provide patients with biliary tract cancer with a designated point of contact within the multidisciplinary team for advice and support (such as a nurse specialist). E Ensure full access to palliative care and symptom management (including pain control) for patients with biliary tract cancer. E Adjuvant chemotherapy: As per ESMO 2023 guidelines, consider offering adjuvant chemotherapy with capecitabine in patients with gallbladder cancer following resection. B As per ASCO 2019 guidelines: Offer adjuvant capecitabine chemotherapy for 6 months in patients with resected biliary tract cancer. B Consider offering chemoradiotherapy in patients with gallbladder cancer with a microscopically positive surgical margin resection (R1). C Definitive systemic therapy (first-line therapy): offer cisplatin plus gemcitabine as first-line therapy in patients with a performance status of 0-1. A Show 3 more Landmark trials: TOPAZ-1 In patients with previously untreated unresectable or metastatic biliary tract cancer or with recurrent disease, durvalumab was superior to placebo with respect to overall survival. Do-Youn Oh et al. NEJM Evid. 2022. Definitive systemic therapy, second- and later-line therapy: As per ESMO 2023 guidelines, offer 5-fluorouracil, leucovorin, and oxaliplatin as second-line therapy after cisplatin plus gemcitabine. A Show 7 more As per SITC 2023 guidelines, offer pembrolizumab monotherapy in patients with previously treated, advanced high MSI/MMR-deficient biliary tract cancer. Offer dostarlimab monotherapy for MMR-deficient tumors only. B Show 3 more 6. Therapeutic procedures Radiotherapy: consider offering radiotherapy after completion of adjuvant capecitabine in selected patients (R1 resection of gallbladder carcinoma). C Biliary stenting: https://web.pathway.md/diseases/rec7AzQA8CnJmT9L8 3/7 6/24/23, 2:54 AM Gallbladder cancer Pathway As per ESMO 2023 guidelines, perform biliary drainage and subsequent treatment in patients with biliary obstruction. Perform percutaneous transhepatic drainage when endoscopic access is not possible. B Prefer a metal stent in patients with a life expectancy of > 3 months. B Show 2 more As per ASGE 2021 guidelines, consider performing either endoscopic or percutaneous transhepatic biliary drainage in patients with unresectable malignant hilar obstruction undergoing palliative drainage. Make the final decision based on patient preferences, disease characteristics, and local expertise. C Show 3 more As per ACR 2019 guidelines: Place a percutaneous internal/external biliary catheter as an initial therapeutic procedure in patients with malignant hilar obstruction. B Place an endoscopic internal biliary catheter with a removable plastic stent as an initial therapeutic procedure in patients with dilated bile ducts and coagulopathy (INR > 2.0 or platelet count < 60, 000) or moderate-to-massive ascites. B 7. Perioperative care Preoperative care (counseling): Provide preoperative information and counseling regarding the upcoming liver surgery. Consider using brochures and multimedia support to improve verbal counseling. B Advise preoperative smoking cessation at least 4 weeks before hepatectomy. Advise alcohol cessation in heavy drinkers (> 24 g/day for females or > 36 g/day for males) 4-8 weeks before surgery. A Preoperative care (nutrition): obtain a nutritional assessment before liver surgery. Administer enteral supplementation at least 7-14 days before surgery to optimize nutritional status in malnourished patients (weight loss > 10% or > 5% over 3 months and reduced BMI or a low fat- free mass index). A Show 2 more Preoperative care (rehabilitation): offer prehabilitation in high-risk patients (elderly, malnourished or overweight patients, smokers, or patients with psychological disorders) before liver surgery. Initiate prehabilitation 4-6 weeks before the operation depending upon the urgency of surgery. Insufficient evidence to recommend the content (physical exercises, dietary interventions, or anxiety reduction exercises) and duration of the prehabilitation program for liver surgery. B Preoperative care (biliary drainage): perform biliary drainage in the cholestatic liver (> 50 mmol/L). Avoid performing surgery until the bilirubin level drops < 50 mmol/L. B Preoperative care (antibiotic prophylaxis): administer antibiotic prophylaxis (such as cefazolin) within 60 minutes before surgical incision with no extension into the postoperative period. https://web.pathway.md/diseases/rec7AzQA8CnJmT9L8 4/7 6/24/23, 2:54 AM Gallbladder cancer Pathway Consider administering a targeted antibiotic preemptive regimen based on preoperative bile culture in case of complex liver surgery with biliary reconstruction. B Preoperative care (corticosteroids): administer a preoperative dose of corticosteroids (methylprednisolone 500 mg). Insufficient evidence for its use in diabetic patients undergoing liver surgery. B Preoperative care (preanesthetic medication): avoid administering long-acting anxiolytic drugs, particularly in the elderly. D Show 3 more Intraoperative care (anesthesia and analgesia): Administer multimodal analgesia, including the potential use of intrathecal opioids, both for open A and laparoscopic surgery. B Recognize that thoracic epidural analgesia can provide excellent analgesia for open liver surgery but has significant disadvantages. Do not use regional anesthesia techniques in laparoscopic surgery as multimodal analgesia combined with judicious IV opioids provide functional analgesia. Perform continuous local anesthetic wound infiltration to provide lower complication rates and overall equivalent analgesia to thoracic epidural analgesia. Perform local anesthetic transversus abdominis plane blockade as a supplement to standard analgesia to improve pain control and reduce opioid usage. A Intraoperative care (temperature management): maintain perioperative normothermia with multimodal temperature management (including circulating water garments or forced warm air) during open and minimally invasive liver surgery. B Intraoperative care (fluid management): Maintain low central venous pressure (< 5 cmH O) with close monitoring during hepatic transection. A Prefer balanced crystalloids over 0.9% saline or colloids for fluid maintenance. Provide goal- directed fluid therapy to optimize cardiac output and end-organ perfusion, recognizing that this may be particularly beneficial after the intraoperative liver resection during a low central venous pressure state to restore tissue perfusion, with patients having comorbidities and reduced cardiac function benefiting the most. A Postoperative care (thromboprophylaxis): administer routine postoperative LMWH or UFH to reduce the risk of thromboembolic events unless exceptional circumstances make this unsafe. Use intermittent pneumatic compression devices to reduce this risk further. B Postoperative care (early mobilization): initiate early mobilization (out of bed) after liver surgery from the operative day until hospital discharge. Insufficient evidence regarding the optimal duration of mobilization. B Postoperative care (nutrition): implement early oral intake with a normal diet after hepatectomy. Assess the individualized needs for artificial nutrition in malnourished patients, patients with complications causing several days of fasting, and patients with liver cirrhosis. Prefer enteral administration for artificial nutrition. A Show 2 more https://web.pathway.md/diseases/rec7AzQA8CnJmT9L8 5/7 6/24/23, 2:54 AM Gallbladder cancer Pathway Postoperative care (antiemetics): use a multimodal approach to postoperative nausea and vomiting. Administer postoperative nausea and vomiting prophylaxis with at least 2 antiemetic drugs, such as dexamethasone and ondansetron. A Postoperative care (laxatives): insufficient evidence to support the routine use of postoperative laxatives, gum chewing, herbal medicine, or decoction to stimulate bowel movement after liver surgery. I 8. Surgical interventions Surgical resection (indications): perform radical surgery (including lymphadenectomy) as the only curative-intent treatment for biliary tract cancers. Decide on the exact nature and extent of surgery depending on tumor subtype and location agreed at a specialist hepatobiliary multidisciplinary tumor board meeting. B Show 3 more Surgical resection (technical considerations): perform liver resection laparoscopically, in trained teams and when clinically appropriate, to reduce the postoperative length of stay and complication rates. B Show 3 more 9. Specific circumstances Patients with gastric outlet obstruction: consider placing self-expandable metallic stents or performing surgical gastrojejunostomy in patients with incurable malignant gastric outlet obstruction undergoing palliative intervention. Decide between these approaches based on patient characteristics and preferences, multidisciplinary input, and local expertise. C Show 2 more 10. Follow-up and surveillance Assessment of treatment response: Consider obtaining CA 19-9 for the assessment of treatment response. C Re-assess patients by a multidisciplinary team to discuss surgery in case of response following locoregional or systemic treatment of locally advanced tumors. B Follow-up: follow up patients developing treatment-related complications and cancer recurrence. Consider obtaining surveillance with 3-6 monthly visits during the first 2 years and 6-12-monthly visits for up to 5 years or as clinically indicated. Consider obtaining clinical assessment, laboratory tests, tumor markers, and chest and abdominopelvic CT. B Show 4 more Rehabilitation: consider offering rehabilitation to counteract impairments related to cancer and its treatments to maximize the quality of life in survivorship. B https://web.pathway.md/diseases/rec7AzQA8CnJmT9L8 6/7 6/24/23, 2:54 AM Gallbladder cancer Pathway References 1. Ga tan-Romain Joliat, Kosuke Kobayashi, Kiyoshi Hasegawa et al. Guidelines for Perioperative Care for Liver Surgery: Enhanced Recovery After Surgery ERAS Society Recommendations 2022. World J Surg. 2023 Jan;47 1 11 34. Open 2. Bashar J Qumseya, Laith H Jamil, Badih Joseph Elmunzer et al. ASGE guideline on the role of endoscopy in the management of malignant hilar obstruction. Gastrointest Endosc. 2021 Aug;94 2 222 234.e22. Open 3. Jean-Marc Dumonceau, Andrea Tringali, Ioannis S Papanikolaou et al. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy ESGE Clinical Guideline Updated October 2017. Endoscopy. 2018 Sep;50 9 910 930. Open 4. J W Valle, I Borbath, S A Khan et al. Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v28-v37. Open 5. European Association for the Study of the Liver. EASL Clinical Practice Guidelines on Sclerosing Cholangitis. J Hepatol. 2022 May 31;S0168 8278 22 00326 9. Open 6. A Vogel, J Bridgewater, J Edeline et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34 2 127 140. Open 7. Rachna T Shroff, Erin B Kennedy, Melinda Bachini et al. Adjuvant Therapy for Resected Biliary Tract Cancer: ASCO Clinical Practice Guideline. J Clin Oncol. 2019 Apr 20;37 12 1015 1027. Open 8. Expert Panel on Interventional Radiology:, Alexandra H Fairchild, Eric J Hohenwalter et al. ACR Appropriateness Criteria Radiologic Management of Biliary Obstruction. J Am Coll Radiol. 2019 May;16 5S S196 S213. Open 9. Ronan J Kelly, Katherine Bever, Joseph Chao et al. Society for Immunotherapy of Cancer SITC clinical practice guideline on immunotherapy for the treatment of gastrointestinal cancer. J Immunother Cancer. 2023 Jun;11 6):e006658. Open 10. ASGE Standards of Practice Committee, Terry L Jue, Andrew C Storm et al. ASGE guideline on the role of endoscopy in the management of benign and malignant gastroduodenal obstruction. Gastrointest Endosc. 2021 Feb;93 2 309 322.e4. Open https://web.pathway.md/diseases/rec7AzQA8CnJmT9L8 7/7