Abstract
Background
The purpose of this study was to evaluate laparoscopy-assisted distal gastrectomy (LADG) compared to open distal gastrectomy (ODG) in the treatment of early gastric cancer with respect to survival, surgical outcomes, complications, and quality of life (QOL).
Methods
One hundred sixty-four patients with cT1N0M0 and cT1N1M0 distal gastric cancer were randomly assigned to either the LADG group or the ODG group. The primary end point was the 5-year disease-free survival (DFS) rate. Complications were classified using the accordion severity classification of postoperative complications scheme. QOL was measured using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-STO22 preoperatively and postoperatively during regular follow-up visits. This trial is registered at ClinicalTrials.gov (NCT00546468).
Results
The median (range) follow-up period was 74.3 (24.8–90.8) months. The LADG and ODG groups showed similar survival [5-year DFS rate: 98.8 % vs. 97.6 %, respectively (P = 0.514), 5-year overall survival (OS) rate: 97.6 vs. 96.3 %, respectively (P = 0.721)] or overall complication rate (29.3 vs. 42.7 %, respectively; P = 0.073). Mild complications were significantly less frequent in the LADG group than in the ODG group (23.2 vs. 41.5 %; P = 0.012). The rates of moderate, severe, and long-term complications (i.e., 31 days to 5 years after surgery) did not differ significantly between groups. No clinically meaningful differences were detected between the two groups in long-term QOL.
Conclusion
LADG showed similar DFS and OS compared to ODG in treating early gastric cancer. Marginal benefits in mild complications were observed with LADG. LADG did not show advantages over ODG regarding other complications and long-term QOL.
Similar content being viewed by others
References
Reddick EJ, Olsen DO (1989) Laparoscopic laser cholecystectomy. A comparison with mini-lap cholecystectomy. Surg Endosc 3:131–133
Clinical Outcomes of Surgical Therapy Study Group (2004) A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 350:2050–2059
Colon Cancer Laparoscopic or Open Resection Study Group, Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Påhlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ (2009) Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol 10:44–52
Jayne DG, Guillou PJ, Thorpe H, Quirke P, Copeland J, Smith AMH, Heath RM, Brown JM (2007) Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. J Clin Oncol 25:3061–3068
Kitano S, Iso Y, Moriyama M, Sugimachi K (1994) Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc 4:146–148
Kim YW, Baik YH, Yun YH, Nam BH, Kim DH, Choi IJ, Bae JM (2008) Improved quality of life outcomes after laparoscopy-assisted distal gastrectomy for early gastric cancer: results of a prospective randomized clinical trial. Ann Surg 248:721–727
Hayashi H, Ochiai T, Shimada H, Gunji Y (2005) Prospective randomized study of open versus laparoscopy-assisted distal gastrectomy with extraperigastric lymph node dissection for early gastric cancer. Surg Endosc 19:1172–1176
Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY (2010) Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report: a phase III multicenter, prospective, randomized trial (KLASS Trial). Ann Surg 251:417–420
Kitano S, Shiraishi N, Fujii K, Yasuda K, Inomata M, Adachi Y (2002) A randomized controlled trial comparing open vs laparoscopy-assisted distal gastrectomy for the treatment of early gastric cancer: an interim report. Surgery 131:S306–S311
Lee JH, Han HS (2005) A prospective randomized study comparing open vs laparoscopy-assisted distal gastrectomy in early gastric cancer: early results. Surg Endosc 19:168–173
Huscher CG, Mingoli A, Sgarzini G, Sansonetti A, Di Paola M, Recher A, Ponzano C (2005) Laparoscopic versus open subtotal gastrectomy for distal gastric cancer: five-year results of a randomized prospective trial. Ann Surg 241:232–237
Japanese Gastric Cancer Association (1998) Japanese Classification of Gastric Carcinoma—2nd English Edition. Gastric Cancer 1:10–24
Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213
Fayers P, Bottomley A (2002) Quality of life research within the EORTC—the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer 38(4):S125–S133
Blazeby JM, Conroy T, Bottomley A, Vickery C, Arraras J, Sezer O, Moore J, Koller M, Turhal NS, Stuart R, van Cutsem E, D’haese S, Coens C (2004) Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-STO 22, to assess quality of life in patients with gastric cancer. Eur J Cancer 40:2260–2268
Osoba D, Rodrigues G, Myles J, Zee B, Pater J (1998) Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16:139–144
Littell RC, Milliken GA, Stroup WW, Wolfinger RD, Schabenberber O (2006) SAS for mixed models, 2nd edn. SAS Publishing, Cary
Greene FL, Kercher KW, Nelson H, Teigland CM, Boller AM (2007) Minimal access cancer management. CA Cancer J Clin 57:130–146
Wente MN, Seiler CM, Uhl W, Buchler MW (2003) Perspectives of evidence-based surgery. Dig Surg 20:263–269
Braga M, Frasson M, Vignali A, Zuliani W, Civelli V, Di Carlo V (2005) Laparoscopic vs. open colectomy in cancer patients: long-term complications, quality of life, and survival. Dis Colon Rectum 48:2217–2223
Pugliese R, Maggioni D, Sansonna F, Ferrari GC, Forgione A, Costanzi A, Magistro C, Pauna J, Di Lernia S, Citterio D, Brambilla C (2009) Outcomes and survival after laparoscopic gastrectomy for adenocarcinoma. Analysis on 65 patients operated on by conventional or robot-assisted minimal access procedures. Eur J Surg Oncol 35:281–288
Lee SW, Nomura E, Bouras G, Tokuhara T, Tsunemi S, Tanigawa N (2010) Long-term oncologic outcomes from laparoscopic gastrectomy for gastric cancer: a single-center experience of 601 consecutive resections. J Am Coll Surg 211:33–40
Ryu KW, Kim YW, Lee JH, Nam BH, Kook MC, Choi IJ, Bae JM (2008) Surgical complications and the risk factors of laparoscopy-assisted distal gastrectomy in early gastric cancer. Ann Surg Oncol 15:1625–1631
Katai H, Sasako M, Fukuda H, Nakamura K, Hiki N, Saka M, Yamaue H, Yoshikawa T, Kojima K, JCOG Gastric Cancer Surgical Study Group (2010) Safety and feasibility of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: a multicenter phase II trial (JCOG 0703). Gastric Cancer 13:238–244
Jiang X, Hiki N, Nunobe S, Kumagai K, Nohara K, Sano T, Yamaguchi T (2012) Postoperative pancreatic fistula and the risk factors of laparoscopy-assisted distal gastrectomy for early gastric cancer. Ann Surg Oncol 19:115–121
Adachi Y, Shiraishi N, Shiromizu A, Bandoh T, Aramaki M, Kitano S (2000) Laparoscopy-assisted Billroth I gastrectomy compared with conventional open gastrectomy. Arch Surg 135:806–810
Strong V, Devaud N, Allen P, Gonen M, Brennan M, Coit D (2009) Laparoscopic versus open subtotal gastrectomy for adenocarcinoma: a case–control study. Ann Surg Oncol 16:1507–1513
Watson DI, Devitt PG, Game PA (1995) Laparoscopic Billroth II gastrectomy for early gastric cancer. Br J Surg 82:661–662
Ohtani H, Tamamori Y, Noguchi K, Azuma T, Fujimoto S, Oba H, Aoki T, Minami M, Hirakawa K (2010) A meta-analysis of randomized controlled trials that compared laparoscopy-assisted and open distal gastrectomy for early gastric cancer. J Gastrointest Surg 14:958–964
Ding J, Liao GQ, Liu HL, Liu S, Tang J (2011) Meta-analysis of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer. J Surg Oncol 105(3):297–303
Guzman E, Pigazzi A, Lee B, Soriano P, Nelson R, Benjamin Paz I, Trisal V, Kim J, Ellenhorn J (2009) Totally laparoscopic gastric resection with extended lymphadenectomy for gastric adenocarcinoma. Ann Surg Oncol 16:2218–2223
Varela JE, Hiyashi M, Nguyen T, Sabio A, Wilson SE, Nguyen NT (2006) Comparison of laparoscopic and open gastrectomy for gastric cancer. Am J Surg 192:837–842
Shehzad K, Mohiuddin K, Nizami S, Sharma H, Khan IM, Memon B, Memon MA (2007) Current status of minimal access surgery for gastric cancer. Surg Oncol 16:85–98
Kim W, Song KY, Lee HJ, Han SU, Hyung WJ, Cho GS (2008) The impact of comorbidity on surgical outcomes in laparoscopy-assisted distal gastrectomy: a retrospective analysis of multicenter results. Ann Surg 248:793–799
Noshiro H, Shimizu S, Nagai E, Ohuchida K, Tanaka M (2003) Laparoscopy-assisted distal gastrectomy for early gastric cancer: is it beneficial for patients of heavier weight? Ann Surg 238:680–685
Acknowledgments
This work was supported by a Grant (NCC 0310060-1,2,3) from the National Cancer Center, South Korea. We thank Jae Gahb Park, MD, Jin Soo Lee, MD, Jae-Moon Bae, MD, Seung Hoon Lee, MD, previous and present staff members of the Center for Gastric Cancer (Myeong-Cherl Kook, MD, Jong Seok Lee, MD, Sang-Gyun Kim, MD, Ho Joon Song, MD, Il Ju Choi, MD, Chan Gyu Kim, MD, Jong Yeul Lee, M.D., Soo Jeong Cho, MD, Ji Yoon Rho, M.D.), scrub nurses in the operating room, and nurses in the ward for their support during this clinical study. We also thank Hyun-Jung Park, RN, Eun Ju Yoo, RN, Yura Kim, RN, Seonhui Park, RN, Seonmi Kim, RN, Jaehyeun Lee, RN, Iyeong Kim, RN, Miae Park, RN, and Jiyeong Jang, RN, for collecting the data.
Disclosures
Young-Woo Kim, Hong Man Yoon, Young Ho Yun, Byung Ho Nam, Bang Wool Eom, Yong Hae Baik, Sang Eok Lee, Yeji Lee, Young-ae Kim, Ji Yeon Park, and Keun Won Ryu have no conflicts of interest or financial ties to disclose.
Author information
Authors and Affiliations
Corresponding authors
Additional information
Young-Woo Kim and Hong Man Yoon contributed equally to this study.
Rights and permissions
About this article
Cite this article
Kim, YW., Yoon, H.M., Yun, Y.H. et al. Long-term outcomes of laparoscopy-assisted distal gastrectomy for early gastric cancer: result of a randomized controlled trial (COACT 0301). Surg Endosc 27, 4267–4276 (2013). https://doi.org/10.1007/s00464-013-3037-x
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00464-013-3037-x