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Journal of Gastrointestinal Surgery
Published in: Journal of Gastrointestinal Surgery 10/2020

01-10-2020 | Surgery | Review Article

Relevant Clinical Trials for GI Surgeons: a Review of Recent Findings

Authors: Adriana C. Gamboa, Shishir K. Maithel

Published in: Journal of Gastrointestinal Surgery | Issue 10/2020

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Abstract

Over the last decade, a number of practice-changing clinical trials have been published to guide the management of esophageal, gastric, liver, pancreas, appendiceal, and colorectal pathologies. The following review aims to provide a succinct summary of these important trials that merit further critical assessment by every gastrointestinal surgeon. After each review, per the Editors’ request, the authors have provided their humble opinion as to the clinical context and application of the data.
Literature
1.
Fass R. Therapeutic options for refractory gastroesophageal reflux disease. 2012;27(s3):3-7.
2.
Spechler SJ, Hunter JG, Jones KM, et al. Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn. The New England journal of medicine. 2019;381(16):1513-1523.CrossRef
3.
Werner YB, Hakanson B, Martinek J, et al. Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. 2019;381(23):2219-2229.PubMed
4.
Stahl M, Walz MK, Riera-Knorrenschild J, et al. Preoperative chemotherapy versus chemoradiotherapy in locally advanced adenocarcinomas of the oesophagogastric junction (POET): Long-term results of a controlled randomised trial. Eur J Cancer. 2017;81:183-190.CrossRef
5.
Shapiro J, van Lanschot JJB, Hulshof M, et al. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015;16(9):1090-1098.CrossRef
6.
Cunningham D, Allum WH, Stenning SP, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. The New England journal of medicine. 2006;355(1):11-20.CrossRef
7.
Al-Batran SE, Homann N, Pauligk C, et al. Perioperative chemotherapy with fluorouracil plus leucovorin, oxaliplatin, and docetaxel versus fluorouracil or capecitabine plus cisplatin and epirubicin for locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4): a randomised, phase 2/3 trial. Lancet (London, England). 2019;393(10184):1948-1957.CrossRef
8.
Noh SH, Park SR, Yang H-K, et al. Adjuvant capecitabine plus oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): 5-year follow-up of an open-label, randomised phase 3 trial. The Lancet Oncology. 2014;15(12):1389-1396.CrossRef
9.
Macdonald JS, Smalley SR, Benedetti J, et al. Chemoradiotherapy after Surgery Compared with Surgery Alone for Adenocarcinoma of the Stomach or Gastroesophageal Junction. New England Journal of Medicine. 2001;345(10):725-730.CrossRef
10.
Lee J, Lim DH, Kim S, et al. Phase III trial comparing capecitabine plus cisplatin versus capecitabine plus cisplatin with concurrent capecitabine radiotherapy in completely resected gastric cancer with D2 lymph node dissection: the ARTIST trial. J Clin Oncol. 2012;30(3):268-273.CrossRef
11.
Yu J, Huang C, Sun Y, et al. Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial. Jama. 2019;321(20):1983-1992.CrossRef
12.
Lee HJ, Hyung WJ, Yang HK, et al. Short-term Outcomes of a Multicenter Randomized Controlled Trial Comparing Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy to Open Distal Gastrectomy for Locally Advanced Gastric Cancer (KLASS-02-RCT). Ann Surg. 2019;270(6):983-991.CrossRef
13.
Oh Y, Kim MS, Lee YT, Lee CM, Kim JH, Park S. Laparoscopic total gastrectomy as a valid procedure to treat gastric cancer option both in early and advanced stage: A systematic review and meta-analysis. Eur J Surg Oncol. 2020;46(1):33-43.CrossRef
14.
Dematteo RP, Ballman KV, Antonescu CR, et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet (London, England). 2009;373(9669):1097-1104.CrossRef
15.
Joensuu H, Eriksson M, Sundby Hall K, et al. One vs Three Years of Adjuvant Imatinib for Operable Gastrointestinal Stromal Tumor: A Randomized Trial. JAMA. 2012;307(12):1265-1272.CrossRef
16.
Raut CP, Espat NJ, Maki RG, et al. Efficacy and Tolerability of 5-Year Adjuvant Imatinib Treatment for Patients With Resected Intermediate- or High-Risk Primary Gastrointestinal Stromal Tumor: The PERSIST-5 Clinical Trial. JAMA Oncol. 2018;4(12):e184060.CrossRef
17.
Abstract LBA3 ‘IMbrave150: Efficacy and safety results from a ph III study evaluating atezolizumab (atezo) + bevacizumab (bev) vs sorafenib (Sor) as first treatment (tx) for patients (pts) with unresectable hepatocellular carcinoma (HCC)’. ESMO Asia Congress 2019.
18.
Primrose JN, Fox RP, Palmer DH, et al. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019;20(5):663-673.CrossRef
19.
Ben-Josef E, Guthrie KA, El-Khoueiry AB, et al. SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma. J Clin Oncol. 2015;33(24):2617-2622.CrossRef
20.
Shroff RT, Javle MM, Xiao L, et al. Gemcitabine, Cisplatin, and nab-Paclitaxel for the Treatment of Advanced Biliary Tract Cancers: A Phase 2 Clinical Trial. JAMA Oncol. 2019;5(6):824-830.CrossRef
21.
Shroff RT, Kennedy EB, Bachini M, et al. Adjuvant Therapy for Resected Biliary Tract Cancer: ASCO Clinical Practice Guideline. 2019;37(12):1015-1027.
22.
Neoptolemos JP, Dunn JA, Stocken DD, et al. Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial. Lancet (London, England). 2001;358(9293):1576-1585.CrossRef
23.
Oettle H, Neuhaus P, Hochhaus A, et al. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. Jama. 2013;310(14):1473-1481.CrossRef
24.
Neoptolemos JP, Palmer DH, Ghaneh P, et al. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial. The Lancet. 2017;389(10073):1011-1024.CrossRef
25.
Conroy T, Hammel P, Hebbar M, et al. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. 2018;379(25):2395-2406.PubMed
26.
Von Hoff DD, Ervin T, Arena FP, et al. Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine. 2013;369(18):1691-1703.
27.
Versteijne E, Suker M, Groothuis K, et al. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020:Jco1902274.
28.
de Rooij T, van Hilst J, van Santvoort H, et al. Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD): A Multicenter Patient-blinded Randomized Controlled Trial. Ann Surg. 2019;269(1):2-9.CrossRef
29.
Palanivelu C, Senthilnathan P, Sabnis SC, et al. Randomized clinical trial of laparoscopic versus open pancreatoduodenectomy for periampullary tumours. The British journal of surgery. 2017;104(11):1443-1450.CrossRef
30.
Poves I, Burdio F, Morato O, et al. Comparison of Perioperative Outcomes Between Laparoscopic and Open Approach for Pancreatoduodenectomy: The PADULAP Randomized Controlled Trial. Ann Surg. 2018;268(5):731-739.CrossRef
31.
van Hilst J, de Rooij T, Bosscha K, et al. Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours (LEOPARD-2): a multicentre, patient-blinded, randomised controlled phase 2/3 trial. The lancet Gastroenterology & hepatology. 2019;4(3):199-207.CrossRef
32.
Kooby DA, Gillespie T, Bentrem D, et al. Left-sided pancreatectomy: a multicenter comparison of laparoscopic and open approaches. Ann Surg. 2008;248(3):438-446.PubMed
33.
Mehta VV, Fisher SB, Maithel SK, Sarmiento JM, Staley CA, Kooby DA. Is it time to abandon routine operative drain use? A single institution assessment of 709 consecutive pancreaticoduodenectomies. J Am Coll Surg. 2013;216(4):635-642; discussion 642-634.CrossRef
34.
Salminen P, Tuominen R, Paajanen H, et al. Five-Year Follow-up of Antibiotic Therapy for Uncomplicated Acute Appendicitis in the APPAC Randomized Clinical Trial. JAMA. 2018;320(12):1259-1265.CrossRef
35.
Sippola S, Gronroos J, Tuominen R, et al. Economic evaluation of antibiotic therapy versus appendicectomy for the treatment of uncomplicated acute appendicitis from the APPAC randomized clinical trial. The British journal of surgery. 2017;104(10):1355-1361.CrossRef
36.
Jayne D, Pigazzi A, Marshall H, et al. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. Jama. 2017;318(16):1569-1580.CrossRef
37.
Vennix S, Musters GD, Mulder IM, et al. Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel-group, randomised, open-label trial. Lancet (London, England). 2015;386(10000):1269-1277.CrossRef
38.
Schultz JK, Yaqub S, Wallon C, et al. Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: The SCANDIV Randomized Clinical Trial. Jama. 2015;314(13):1364-1375.CrossRef
39.
Kohl A, Rosenberg J, Bock D, et al. Two-year results of the randomized clinical trial DILALA comparing laparoscopic lavage with resection as treatment for perforated diverticulitis. The British journal of surgery. 2018;105(9):1128-1134.CrossRef
40.
Oberkofler CE, Rickenbacher A, Raptis DA, et al. A multicenter randomized clinical trial of primary anastomosis or Hartmann’s procedure for perforated left colonic diverticulitis with purulent or fecal peritonitis. Ann Surg. 2012;256(5):819-826; discussion 826-817.CrossRef
41.
Bolkenstein HE, Consten ECJ, van der Palen J, et al. Long-term Outcome of Surgery Versus Conservative Management for Recurrent and Ongoing Complaints After an Episode of Diverticulitis: 5-year Follow-up Results of a Multicenter Randomized Controlled Trial (DIRECT-Trial). Ann Surg. 2019;269(4):612-620.CrossRef
42.
Goere D, Glehen O, Quenet F, et al. Results of a randomized phase 3 study evaluating the potential benefit of a second-look surgery plus HIPEC in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP- NTC01226394). 2018;36(15_suppl):3531-3531.
43.
Klaver CEL, Wisselink DD, Punt CJA, et al. Adjuvant hyperthermic intraperitoneal chemotherapy in patients with locally advanced colon cancer (COLOPEC): a multicentre, open-label, randomised trial. The lancet Gastroenterology & hepatology. 2019;4(10):761-770.CrossRef
44.
Verwaal VJ, Bruin S, Boot H, van Slooten G, van Tinteren H. 8-year follow-up of randomized trial: cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy in patients with peritoneal carcinomatosis of colorectal cancer. Ann Surg Oncol. 2008;15(9):2426-2432.CrossRef
45.
Quenet F, Elias D, Roca L, et al. A UNICANCER phase III trial of hyperthermic intra-peritoneal chemotherapy (HIPEC) for colorectal peritoneal carcinomatosis (PC): PRODIGE 7. 2018;36(18_suppl):LBA3503-LBA3503.
Metadata
Title
Relevant Clinical Trials for GI Surgeons: a Review of Recent Findings
Authors
Adriana C. Gamboa
Shishir K. Maithel
Publication date
01-10-2020
Publisher
Springer US
Published in
Journal of Gastrointestinal Surgery / Issue 10/2020
Print ISSN: 1091-255X
Electronic ISSN: 1873-4626
DOI
https://doi.org/10.1007/s11605-020-04676-6

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