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Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_1073_Библиотеки_им_академика_М_И_Перельмана

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16.4months for patients who underwent chemotherapy alone (hazard ratio, 1.60; 95% condence interval, 1.43–1.78) [21]. The authors acknowledged the potential for bias, since the reasons for resection and nonresection were not available. Moreover, data from patients who did not meet the inclusion criteria for the trials, such as morbidity or mortality after primary tumor resection, were not available.
P. Goredo and M. R. Weiser
Morbidity andMortality
Resection of the primary tumor is associated with high morbidity. In the iPACS trial, grade2 complications occurred in 38% of the patients and grade3 com­plications occurred in 21% [14]. The rates of anastomotic leak and 30-day mortality were 4%. Additionally, both grade  2 and grade 3 nonhematological adverse events were more frequent than after chemotherapy alone (87% vs. 77% and 48% vs. 34%, respectively). Similarly, the PTR trial found higher morbidity in patients who underwent resection, with postoperative complications in 19% of the patients, including 1 death, and a 30-day readmission rate of 12% [13]. There were no cases of anastomotic leakage. The rate of chemotherapy-related toxicities was approxi­mately 27% in both groups. The CAIRO4 trial reported comparable rates of grade3 toxicity in the two groups (23% for resection vs. 30% for chemotherapy alone, P=0.25) [15]. However, within 60days from randomization, mortality was 11% in the resection group vs. 3% in the chemotherapy group (P=0.03).
Postoperative recovery and morbidity can signicantly delay or sometimes pre­vent initiation of chemotherapy. This has frequently been considered a drawback to resection of the primary tumor in patients with metastasis. In the iPACS trial, the median time to initiation of systemic chemotherapy after surgery was 34days, com­pared with 9days after enrollment for patients who did not undergo resection [14]. In the PTR trial, the median interval from surgery to initiation of systemic chemo­therapy was 25days [13]. In the CAIRO4 trial, the median interval from randomiza­tion to initiation of systemic chemotherapy was 7days for patients who did not undergo resection and 46days for patients who did [15].
Conversion toResectability
The guidelines of the American Society of Colon and Rectal Surgeons advise against primary tumor resection in patients with asymptomatic unresectable stage IV disease and strongly recommend neoadjuvant chemotherapy as a means of facili­tating conversion to resectability [22]. This recommendation is based in part on a 2020 systematic review of 20 trials, which found that neoadjuvant treatment with oxaliplatin- or irinotecan-based chemotherapy plus bevacizumab or cetuximab pro­duced a response in 55–85% of patients and conversion to resectability in 10–61% of patients, with R0 resection rates as high as 54% [23]. The PTR and iPACS trials reported conversion to resectability in 18 and 6% of patients randomized to chemo­therapy alone, respectively [13, 14].
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Natural History ofNonresected Primary Disease
One argument for resecting the primary tumor electively is potential prevention of obstruction, perforation, severe bleeding, or another cancer-related complication. However, these events are relatively rare. In the multicenter prospective phase II trial NSABP C-10, in which patients with an asymptomatic primary tumor and unresectable metastases received oxaliplatin-based chemotherapy and bevaci­zumab, with median follow-up of 21months, 14% of the patients had major mor­bidity related to the primary tumor and 12% required an operation, mostly for obstruction [12]. A 2019 population-based SEER study of 4692 patients with stage IV colorectal cancer (74% of the patients had colon cancer and 26% had rectal can­cer) obtained similar results, with unplanned operations required in only 12% of the patients [24]. In the PTR trial, 4 (18%) of the 22 patients assigned to chemotherapy alone underwent surgery during chemotherapy and 5 (23%) of the 22 patients required interventional therapy (colonic stent placement or salvage radiotherapy) [13]. The rate of palliative surgery in patients assigned to chemotherapy alone was 13% in the iPACS trial and 6% in the CAIRO4 trial [14, 15]. These data indicate that if upfront resection was performed routinely in order to prevent possible acute sur­gery during chemotherapy, approximately 5 to 10 patients would undergo an unnec­essary intervention in order to prevent an emergency intervention in 1 patient. Resection of an asymptomatic primary tumor, therefore, does not provide a signi­cant prophylactic benet for most patients.
It is important to note that complications associated with an untreated primary tumor may be more common for rectal cancer than for colon cancer. In a recent single-institution series from Memorial Sloan Kettering Cancer Center, of 190 patients who did not undergo an upfront or elective intervention for the primary tumor, 68 (36%) experienced complications; 42 (62%) of the 68 patients ended up with a diverting ostomy [25]. These data suggest that closer follow-up may be needed for metastatic rectal cancer than for metastatic colon cancer.
Recommendations Based ontheData
Asymptomatic patients with unresectable metastatic colorectal cancer should pro­ceed with systemic therapy and not undergo resection of the primary tumor (evi­dence quality high; strong recommendation).
Personal View oftheData
Until recently, the value of resecting an asymptomatic primary tumor in patients with incurable metastatic colon cancer was debatable, based on biased retrospective series. We now have data from randomized controlled trials demonstrating the futil­ity of resection for most patients. Immediate surgery is associated with morbidity and is not associated with longer survival, and it can delay initiation of systemic chemotherapy. Timely intervention can rescue patients who develop complications related to the primary lesion.
Clinical judgment should guide the decision-making process, with the goal of optimizing survival and balancing the quality of life. Our current practice is to
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P. Goredo and M. R. Weiser
administer chemotherapy rst, based on the fact that in a subset of patients, current multimodal therapies substantially prolong life and facilitate the possibility of a curative resection.
When developing a treatment plan, patients’ symptoms, colonoscopy reports, and cross-sectional images should be carefully reviewed. In patients who present with anemia, the symptoms can be managed medically, with improvement within two to four cycles of chemotherapy. Similarly, upfront chemotherapy with close observation may be safely employed in patients with mild obstructive symptoms, which generally improve with systemic treatment. However, when patients present with signicant symptoms or evidence of proximal dilation on CT, surgical inter­vention in the form of a diverting ostomy or tumor resection should be considered, keeping in mind the signicant risk of complications and potential delay in chemotherapy.
Future investigations may identify clinicopathologic or molecular factors that can be used to predict which patients may indeed benet form upfront surgery. Currently, based on the evidence, the standard of care should be upfront chemo­therapy, evaluation of response, estimation of prognosis, and further discussion in a multidisciplinary setting.
References
1. U.S.Cancer Statistics Working Group. U.S.Cancer Statistics Data Visualizations Tool, based on 2020 submission data (1999–2018) www.cdc.gov/cancer/dataviz: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2021.
2. Corsini EM, Mitchell KG, Correa A, Morris VK, Antonoff MB.Effect of primary colorectal cancer tumor location on survival after pulmonary metastasectomy. J Thorac Cardiovasc Surg. 2021;162(1):296–305.
3. Tomlinson JS, Jarnagin WR, DeMatteo RP, Fong Y, Kornprat P, Gonen M, et al. Actual 10-year survival after resection of colorectal liver metastases denes cure. J Clin Oncol. 2007;25(29):4575–80.
4. Engstrand J, Nilsson H, Strömberg C, Jonas E, Freedman J.Colorectal cancer liver metas­tases – a population-based study on incidence, management and survival. BMC Cancer. 2018;18(1):78.
5. National Comprehensive Cancer Network. NCCN clinical practical guidelines in oncology: colon cancer: NCCN; (updated Version 1.2019 – March 15, 20192019). Available from:
https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf.
6. Weiser MR.Primum non nocere: a word of caution regarding prophylactic colectomy in the setting of incurable metastatic disease. Ann Surg Oncol. 2011;18(12):3229–31.
7. Yamada Y, Takahari D, Matsumoto H, Baba H, Nakamura M, Yoshida K, etal. Leucovorin, uorouracil, and oxaliplatin plus bevacizumab versus S-1 and oxaliplatin plus bevacizumab in patients with metastatic colorectal cancer (SOFT): an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2013;14(13):1278–86.
8. Yamazaki K, Nagase M, Tamagawa H, Ueda S, Tamura T, Murata K, etal. Randomized phase III study of bevacizumab plus FOLFIRI and bevacizumab plus mFOLFOX6 as rst­line treatment for patients with metastatic colorectal cancer (WJOG4407G). Ann Oncol. 2016;27(8):1539–46.
9. Ahmed S, Leis A, Fields A, Chandra-Kanthan S, Haider K, Alvi R, etal. Survival impact of surgical resection of primary tumor in patients with stage IV colorectal cancer: results from a large population-based cohort study. Cancer. 2014;120(5):683–91.
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10. Ishihara S, Hayama T, Yamada H, Nozawa K, Matsuda K, Miyata H, etal. Prognostic impact of primary tumor resection and lymph node dissection in stage IV colorectal cancer with unre­sectable metastasis: a propensity score analysis in a multicenter retrospective study. Ann Surg Oncol. 2014;21(9):2949–55.
11. Poultsides GA, Servais EL, Saltz LB, Patil S, Kemeny NE, Guillem JG, etal. Outcome of primary tumor in patients with synchronous stage IV colorectal cancer receiving combination chemotherapy without surgery as initial treatment. J Clin Oncol. 2009;27(20):3379–84.
12. McCahill LE, Yothers G, Sharif S, Petrelli NJ, Lai LL, Bechar N, etal. Primary mFOLFOX6 plus bevacizumab without resection of the primary tumor for patients presenting with surgi­cally unresectable metastatic colon cancer and an intact asymptomatic colon cancer: denitive analysis of NSABP trial C-10. J Clin Oncol. 2012;30(26):3223–8.
13. Park EJ, Baek JH, Choi GS, Park WC, Yu CS, Kang SB, et al. The role of primary tumor resec­tion in colorectal cancer patients with asymptomatic, synchronous, unresectable metastasis: a multicenter randomized controlled trial. Cancers (Basel). 2020;12(8):2306.
14. Kanemitsu Y, Shitara K, Mizusawa J, Hamaguchi T, Shida D, Komori K, et al. Primary tumor resection plus chemotherapy versus chemotherapy alone for colorectal cancer patients with asymptomatic, synchronous unresectable metastases (JCOG1007; iPACS): a randomized clin­ical trial. J Clin Oncol. 2021;39(10):1098–107.
15. van der Kruijssen DEW, Elias SG, Vink GR, van Rooijen KL, t Lam-Boer J, Mol L, etal. Sixty-day mortality of patients with metastatic colorectal cancer randomized to systemic treat­ment vs primary tumor resection followed by systemic treatment: the CAIRO4 phase 3 ran­domized clinical trial. JAMA Surg. 2021;156(12):1093–101.
16. Moritani K, Kanemitsu Y, Shida D, Shitara K, Mizusawa J, Katayama H, etal. A randomized controlled trial comparing primary tumour resection plus chemotherapy with chemotherapy alone in incurable stage IV colorectal cancer: JCOG1007 (iPACS study). Jpn J Clin Oncol. 2020;50(1):89–93.
17. Alawadi Z, Phatak UR, Hu CY, Bailey CE, You YN, Kao LS, etal. Comparative effectiveness of primary tumor resection in patients with stage IV colon cancer. Cancer. 2017;123(7):1124–33.
18. Ahmed S, Fields A, Pahwa P, Chandra-Kanthan S, Zaidi A, Le D, et al. Surgical resection of primary tumor in asymptomatic or minimally symptomatic patients with stage IV colorectal cancer: a Canadian province experience. Clin Colorectal Cancer. 2015;14(4):e41–7.
19. Shida D, Hamaguchi T, Ochiai H, Tsukamoto S, Takashima A, Boku N, et al. Prognostic impact of palliative primary tumor resection for unresectable stage 4 colorectal cancer: using a propensity score analysis. Ann Surg Oncol. 2016;23(11):3602–8.
20. Tarantino I, Warschkow R, Worni M, Cerny T, Ulrich A, Schmied BM, et al. Prognostic rel­evance of palliative primary tumor removal in 37,793 metastatic colorectal cancer patients: a population-based, propensity score-adjusted trend analysis. Ann Surg. 2015;262(1):112–20.
21. van Rooijen KL, Shi Q, Goey KKH, Meyers J, Heinemann V, Diaz-Rubio E, etal. Prognostic value of primary tumour resection in synchronous metastatic colorectal cancer: individual patient data analysis of rst-line randomised trials from the ARCAD database. Eur J Cancer. 2018;91:99–106.
22. Vogel JD, Felder SI, Bhama AR, Hawkins AT, Langenfeld SJ, Shaffer VO, etal. The American Society of Colon and Rectal Surgeons clinical practice guidelines for the Management of Colon Cancer. Dis Colon Rectum. 2022;65(2):148–77.
23. Bolhuis K, Kos M, van Oijen MGH, Swijnenburg RJ, Punt CJA.Conversion strategies with chemotherapy plus targeted agents for colorectal cancer liver-only metastases: a systematic review. Eur J Cancer. 2020;141:225–38.
24. Lorimer PD, Motz BM, Kirks RC, Han Y, Symanowski JT, Hwang JJ, etal. Frequency of unplanned surgery in patients with stage IV colorectal cancer receiving palliative chemother­apy with an intact primary: an analysis of SEER-Medicare. J Surg Oncol. 2019;120(3):407–14.
25. Tan WJ, Patil S, Guillem JG, Paty PB, Weiser MR, Nash GM, etal. Primary tumor-related complications and salvage outcomes in patients with metastatic rectal cancer and an untreated primary tumor. Dis Colon Rectum. 2021;64(1):45–52.
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ofLarge Colonic Polyps?
15
SumeyyeYilmaz andEmreGorgun
Introduction
Colorectal cancer is the third most commonly diagnosed cancer and second leading cause of cancer-related mortality globally [1, 2]. Based on adenoma-carcinoma sequence theory, early detection and removal of colorectal neoplasms is essential for improving cancer incidence and mortality [3]. Ideally, a neoplastic lesion should be resected in one-piece (en-bloc) with histologically negative margins (R0). Fortunately, 80–90% of polyps are 1cm and can effectively be managed by con­ventional polypectomy [4]. However, management of large colorectal polyps (2cm) require more advanced resection techniques, as conventional snare-based techniques might result in piecemeal resection, which precludes proper histopatho­logical evaluation and increases the risk for recurrence [5]. Given that large polyps may have an increased risk for harboring malignancy [6], adequate treatment is of the utmost importance. Further, risks of different procedures should be considered.
Search Strategy
A comprehensive literature search of Cochrane Database of Collected Research, EMBASE, and MEDLINE was performed. The search strategy included different combinations of the following terms: “colon or colorectal”, “large polyp or polyp 2 cm”, “polypectomy”, “endoscopic mucosal resection (EMR)”, “endoscopic sub­mucosal dissection (ESD)”, “surgery or colectomy”, “en-bloc resection”,
S. Yilmaz · E. Gorgun (*) Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland, OH, USA e-mail: gorgune@ccf.org
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 K. Umanskiy, N. Hyman (eds.), Difcult Decisions in Colorectal Surgery, Difcult Decisions in Surgery: An Evidence-Based Approach,
https://doi.org/10.1007/978-3-031-42303-1_15
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Table 15.1 PICO table
Intervention
Patients
Patients with large (2 cm) colorectal polyps
ESD Endoscopic Submucosal Dissection, EMR Endoscopic Mucosal Resection, U-EMR Underwater EMR En-bloc resection: Resection of a neoplasm in one piece. R0 resection: En-bloc resection of a lesion with histologically proven negative margins
groups Comparator groups
ESD Conventional
polypectomy EMR U-EMR Hybrid ESD Surgery
EMR Conventional
polypectomy U-EMR Hybrid ESD Surgery
S. Yilmaz and E. Gorgun
Outcomes Primary:
• Postoperative/procedural complications
• En-bloc and R0 resection
• Local recurrence
Secondary:
• Procedure time
• Length of hospital stay
• Cost
“perforation”, “bleeding”, “recurrence” in “All elds”, and the related Mesh terms to identify all English-language publications from 1999 (the year ESD was rst described [7]) to 2022. Since guidelines’ recommendation is to use ESD for resec­tion of polyps larger than 2cm [5, 8], ESD is identied as the intervention group, and studies comparing ESD with any of the following were included: conventional polypectomy (CP), EMR, Underwater EMR (U-EMR), Hybrid ESD, and surgery. However, while conducting the search, studies comparing EMR with different tech­niques (other than ESD) were found. They were also included to give a more com­prehensive information about efcacy and safety of different resection techniques. Primary outcomes were: postoperative/procedural complications (mainly bleeding and perforation), en-bloc resection, R0 resection, and tumor recurrence. Secondary outcomes were: procedure time, length of hospital stay, and cost (Table 15.1). Studies were excluded according to the following criteria: (a) Articles without a control group (non-comparative studies); (b) Articles including patients with polyps 2cm without a subgroup analysis for patients with large polyps; (c) Conference abstracts (since evaluation for quality of evidence would not be possible), system­atic reviews, meta-analyses, guidelines, book chapters, editorials. Only the most recent study was included in the presence of multiple articles reporting data from the same study population. The references of the included studies were reviewed to identify additional studies that were incorporated as appropriate.
Results
Colorectal ESD was rst described in 1999 [7]. Since then, literature on the out­comes of different management techniques for colorectal polyps has been expand­ing. Guidelines recommend CP and/or EMR for most supercial colorectal lesions and ESD for lesions larger than 2cm and/or lesions with suspicion of submucosal
15 What Are theOptions forManagement ofLarge Colonic Polyps?
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invasion [5, 8]. However, reports published in this area are mostly case series (non- comparative) and/or include polyps regardless of their size without a subgroup analysis for large polyps.
12 studies comparing ESD with: CP&EMR [9], EMR [1015], U-EMR [16], Hybrid ESD [12, 1719], and surgery [20] were identied and summarized in Table15.2. 5 studies comparing EMR with: CP [21], U-EMR [22, 23], Hybrid ESD [12], and surgery [24] were identied and summarized in Table15.3. 1 study [12] was included in both tables, as it compared the outcomes of EMR, Hybrid ESD, and ESD. Reports included: 2 randomized controlled trials (RCTs) [21, 22], 2 prospec­tive cohort [9, 18] and 12 retrospective cohort studies [1017, 19, 20, 23, 24].
181
En-Bloc, R0 andComplete Resection
In terms of efcacy of different techniques, most studies [914, 1619, 22, 23] reported en-bloc resection (resection of a neoplasm in one-piece) with some [10, 12,
14, 1619] reporting R0 resection (en-bloc resection of a lesion with histologically
proven negative margins) rates. Oka etal. [9] combined CP with EMR and com­pared the en-bloc resection rate with ESD, and reported that ESD achieved signi­cantly higher en-bloc resection rates. Studies comparing ESD with EMR reported signicantly higher en-bloc [1114] and R0 [12, 14] resection rates with ESD.Iizuka etal. [10] compared 38 ESDs with 83 EMRs and found no signicant difference between en-bloc resection rates. However, R0 resection rate was signicantly higher for ESD.Hybrid ESD achieved similar en-bloc and R0 resection rates with ESD in 2 studies [18, 19]; whereas in other 2 studies [12, 17], ESD achieved signicantly higher en-bloc and R0 resection rates.
Chien etal. [23] compared EMR with U-EMR, and reported that there was no statistically signicant difference in en-bloc resection rates. Lee etal. [12] reported that Hybrid ESD achieved higher en-bloc and R0 resection rates when compared with EMR.
2 studies [ 15, 21] reported complete resection as resection of a lesion with his­tologically proven negative margins (instead of resection of a lesion in one-piece with negative margins). ESD achieved signicantly higher complete resection rate when compared with EMR [15], as EMR with CP [21]. When EMR was compared with U-EMR, there was no signicant difference in incomplete resection rates [22].
Postoperative/Procedural Complications
Regarding safety of different techniques, most commonly reported complications were bleeding [9, 1119, 22, 23] and perforation [919]. 5 studies [12, 14, 20, 22, 24] reported total complication rates. Surgery was associated with higher complication rates compared to EMR [24] and ESD [20]. Bleeding (either early or delayed) rates were not different between different techniques in the majority of the studies [9, 11
19, 22]. Oka etal. [9] reported no signicant differences between perforation rates of
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Quality of
evidence
Moderate
Low
Moderate
Low
S. Yilmaz and E. Gorgun
Low
NSNSp<0.00001
2.5% vs. 1.4%
Delayed bleeding
CP & EMR
p<0.01
p=0.056NSp<0.05
1.1% vs. 0.9%
95.0% vs. 53.2%
1.4% vs. 6.8%
8% vs. 1%
Perforation
En bloc resection
Recurrence
(1,029)
61% vs. 54%
En bloc resection
NSNSp<0.0001
58% vs. 37%
1.4% vs. 3.1%
6.2% vs. 1.3%
84% vs. 33%
R0 resection
Perforation
En bloc resection
p<0.0001
p<0.0001
p=0.024NSp<0.001
2% vs. 14%
108±71 vs. 29±25
11.5% vs. 5.7%
Recurrence
Procedure time, min
p<0.001
0.6% vs. 0%
8% vs. 0%
92.7% vs. 42.9%
Bleeding
Perforation
En bloc resection
p<0.001
p<0.001
NSNSp=0.048
87.6% vs. 32.9%
0.8% vs. 25.7%
11.5% vs. 15.9%
0.6% vs. 2.9%
8% vs. 2.9%
R0 resection
Recurrence
Complication (any)
Bleeding
PerforationEn bloc
(69)
p=0.004
p=0.006
NS
NS
p=0.04
92.7% vs. 65.2%
87.6% vs. 59.4%
0.8% vs. 3.1%
2.4% vs. 2.9%
5.9% vs. 0%
resection
R0 resection
Recurrence
Perforation
p<0.001
p=0.002
p<0.001
83.5% vs. 48.1%
1.2% vs. 15.4%
87.2±49.7 vs.
29.4±26.1
En bloc resection
Recurrence
Procedure time, min
Intervention
group Control Group Outcome measures Results Signicance
ESD dissection
(816)
Study Design
Cohort
Study
Table 15.2 Studies comparing ESD with other techniques
Oka 2015 [9] Prospective
ESD (38) EMR (83) Perforation
Retrospective
Iizuka 2009
ESD (145) EMR (228) Delayed bleeding
Cohort
[10]
Saito 2009 [11] Retrospective
Cohort
ESD (314) EMR (140) Complication (any)
Lee 2011 [12] Retrospective
Cohort
ESD (314) Hybrid ESD
ESD (85) EMR (104) Bleeding
Retrospective
Cohort
Tajika 2011
[13]
15 What Are theOptions forManagement ofLarge Colonic Polyps?
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Quality of
evidence
Low
NSNSNS
p<0.0001
p<0.0001
9.5% vs. 6.4%
3.8% vs. 4.1%
5.7% vs. 2.3%
87.3% vs. 26.3%
83.4% vs. 26.3%
Bleeding
Perforation
En bloc resection
R0 resection
p=0.026
7.6% vs. 15.2%
Recurrence
Low
p<0.0001
NSNSNS
2.2±1.79 vs.
0.97±1.32
19.1% vs. 12.4%
6.1% vs. 3.3%
Length of stay, days
Intraprocedural
bleeding
p<0.001
p<0.001
p<0.001NSp<0.001
2.6% vs. 4.9%
83.9% vs. 32.2%
0.5% vs. 7.1%
55.4±47.0 vs.
25.6±32.7
2.4±1.1 vs. 2.5±1.4
Delayed bleeding
Perforation
Complete resection
Recurrence
Procedure time, min
Length of stay, days
NS
1480.0±728.0 vs.
729.8±299.7
847.6±823.0 vs.
Cost (initial
resection), p<0.001
Cost (cumulative),
Low
NS
Signicant
N/A
2.7% vs. 5.4%
5.4% vs. 0%
871.9±994.4
p<0.001
99% vs. 61%
Perforation
En bloc resection
183
(continued)
N/ANSSignicant
89% vs. 34%
0% vs 0%
64.8 vs. 6.7
R0 resection
Recurrence
Procedure time, min
Intervention
group Control Group Outcome measures Results Signicance
ESD (157) EMR (217) Complication (any)
Study Design
Retrospective
Cohort
Study
Soliman 2018
[14]
piecemeal (115)
ESD (429) EMR –
Cohort
Ham 2019 [15] Retrospective
ESD (74) U-EMR (74) Delayed bleeding
Retrospective
Cohort
a
Inoue 2021
[16]
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Quality of
evidence
Low
Low
Low
S. Yilmaz and E. Gorgun
Low
NSNSNS
1% vs. 0%
Immediate bleeding
p<0.01
p<0.01
p=0.05
1% vs. 4%
6% vs. 2%
85% vs. 49%
73% vs. 43%
52±37 vs. 40±25
Delayed bleeding
Perforation
En bloc resection
R0 resection
Procedure time, min
(47)
NSNSNSNSp=0.005
3.2% vs. 2.9%
6.5% vs. 8.8%
100% vs. 94.1%
93.5% vs. 91.2%
40.6±22.1 vs.
27.4±12.7
Bleeding
Perforation
En bloc resection
R0 resection
Procedure time, min
(34)
NSNSNSNSp<0.001
1.0% vs. 2.9%
2.9% vs. 5.9%
100% vs. 94.1%
90.2% vs. 76.5%
45.6±30.1 vs.
12.7±7.0
Bleeding
Perforation
En bloc resection
R0 resection
Procedure time, min
(34)
p<0.001NSNS
p<0.001
13% vs. 15%
133±72.7 vs. 136±45
1.5±1.4 vs. 5.2±2.4
ESD/surgery: 60%
Procedure time, min
Length of stay, days
Cost
Intervention
group Control Group Outcome measures Results Signicance
ESD (141) Hybrid ESD
Study Design
Retrospective
Cohort
Study
Byeon 2011
Table 15.2 (continued)
[17]
ESD (36) Hybrid ESD
Cohort
Bae 2016 [18] Prospective
ESD (102) Hybrid ESD
Cohort
Yang 2017 [19] Retrospective
ESD (48) Surgery (48) Complication (any)
Retrospective
Cohort
Gamaleldin
2017 [20]
No information regarding the signicance level for perforation, en bloc and R0 resection rates, and procedure time
a
CP Conventional polypectomy, EMR Endoscopic mucosal resection, ESD Endoscopic submucosal dissection, NS Non-signicant, U-EMR Underwater EMR
En bloc resection: resection of a polyp in one-piece. R0 resection: resection of a polyp in one-piece with histologically proven negative margins. Complete
resection: resection of a polyp with histologically proven negative margins (not necessarily in one-piece)