Endoscopic Treatment for Local Residual Neoplasia
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer,Colorectal Neoplasms,Neoplasms
PROVIDER: 2185609 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Most of the cancers develop from the adenomatous polyps. The therapeutic methods have been established already - endoscopic polypectomy (EPE) for stalked polyps and endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for non-pedunculated polyps. EMR is preferred in European countries over ESD because of its higher feasibility. However, the local residual neoplasia (LRN) after EMR has been reported in 14 - 24 % cases. There is a higher LRN risk in sessile polyps which do not elevate sufficiently after the submucosal injection (non-lifting sign) and the piece-meal resection needs to be used. Therefore, the new method of endoscopic full-thickness resection (FTR) has been developed to resect these lesions.
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Project description:Nowadays endoscopic mucosal resection (EMR) is the gold standard for the removal of large laterally spreading and sessile colorectal lesions ≥ 20 mm. However, recurrence rate after successful EMR (defined by the absence of neoplastic tissue at the completion of the procedure after careful inspection of the post-EMR mucosal defect and margin) is about 15-20%. Consequently, current guidelines recommend a surveillance colonoscopy between 4 and 6 months after resection for detection of residual or recurrent polyp.
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Project description:Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal adenomas, however, maintains some important limitations. In large lesions, EMR can often only be performed in a piecemeal fashion resulting in relatively low R0-resection rates and high recurrence rates. Endoscopic submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer procedural time, but is promising due to the high en-bloc resection rates and the very low recurrence rates. The aim of this multicenter randomized study is to compare EMR and ESD with regard to recurrence rates and radical (R0) resection rates, and to put this into perspective against the costs and complication rates of both strategies and the burden perceived by patients on the long term-term.
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Project description:Colorectal cancer (CRC) is the third most common cancer in men and the second in women worldwide, with 1.65 million new cases and almost 835,000 deaths in 2015. CRC is still a major cause of mortality associated with cancer, although the wide spread of the screening program has led to a reduction in the mortality rate compared to the last decades.
CRCs derive from precancerous lesions that may be polypoid or non-polypoid according to the Paris classification. Thus, resection in an early stage could led to a CRC mortality reduction.
Laterally spreading tumors (LST) are non-polypoid lesions of at least 1 cm in diameter that have lateral growth rather than upward or downward growth.
The prevalence of LSTs ranges from 1 to 6% of all colorectal lesions. LSTs can be divided into two groups: granular LSTs, which include homogeneous and granular mixed forms and non-granular (NG) LSTs, which include pseudo-depressed and flat-elevated forms.
Histologically, 90% of LSTs are adenomas and having a low incidence of invasive neoplasia, these lesions can be removed endoscopically.
However, as evidenced by a recent meta-analysis published by Bogie Roel MM et al on Endoscopy, the type of LST and the distal or proximal colonic localization could represent predictors of submucosal invasion and could simplify the therapeutic decision for the removal of these lesions. GM-LSTs and pseudo-depressed NG-LSTs predominantly localize in the distal portion of the colon and have a submucosal invasion rate of 10,5% and 31,6% respectively.
LSTs can be removed both through endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). The main limitation of EMR is that large lesions require a piecemeal approach, resulting in a non-optimal histological evaluation and a high risk of recurrence. ESD instead allows a higher rate of en bloc resections, thus resulting more curative and reducing the risk of having partial and incomplete resections, which can lead to disease recurrence/non curative resection.
LST-GM are characterized by the presence of a granular appearance with a main nodule and represent approximately 1/4 of the LSTs. There are no guidelines indicating the proper resective technique of these lesions.
The European Society of Gastrointestinal Endoscopy (ESGE) suggests to consider ESD for the removal of colorectal lesions that are > 20 mm in size, with a depressed and irregular morphology or a non-granular surface pattern, as these lesions have a high probability of having a limited submucosal invasion. Moreover ESD can be used to treat lesions that cannot be completely removed with standard polypectomy or EMR.
The investigators propose to perform a multicenter retrospective observational study to define the percentage of cancer in patients with GM-LSTs treated with endoscopic resection in order to evaluate the correlation between pre-resection and post-resection characteristics, defining the best therapeutic approach (en bloc or piecemeal) and avoiding incomplete endoscopic resections or unnecessary surgical procedures.
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Project description:Interventions: Advanced endoscopic resection techniques such as Endoscopic Mucosal Resection (EMR) have provided a minimally invasive alternative to surgery for curative management of advanced mucosal neoplasia. The safety profile and outcomes of EMR techniques are significantly better than surgical resection however significant post resection bleeding remains an ongoing challenge. There is currently no consistently recommended strategy to reduce the risk of post-EMR bleeding that has been adopted as standard of care. In particular, patients on antithrombotic therapy are at high risk of post procedure bleeding and strategies to mitigate this are required.
A recently introduced haemostatic gel (Purastat, 3D-Matrix) that acts as a self assembling nanoparticle matrix has demonstrated efficacy as a topical haemostat in controlling oozing bleeding in a number of anatomical locations including applications in ENT, Gynaecology, and endoscopy.
The haemostatic gel will be applied to the post EMR mucosal defect to consecutive eligible, consenting patients undergoing endoscopic mucosal resection who are on anti-thrombotic therapy (excluding single agent aspirin) or multiple agents. We will be applying aliquots of 1-5mLs of the gel matrix; the exact amount will be determined by the size of the defect remaining post excision of the target lesion. Gel will be applied endoscopically at the time of the procedure via the proceduralist until the entire defect has been covered - this is considered the one and only time the gel will be delivered.
Primary outcome(s): Rate of clinically significant post-procedural bleeding requiring further intervention (such as blood transfusion, admission to hospital, or other blood products (such as platelets, fresh frozen plasma, prothrombinex)
This will be assessed clinically by the presence of gastrointestinal bleeding (such as per-rectal bleeding) where patients were given blood products as documented in the medical record.[30 days post endoscopic procedure]
Study Design: Purpose: Prevention; Allocation: Non-randomised trial
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Project description:Superficial rectal tumors could be removed by ESD with two major advantages showed by the literature: high rate of monobloc resection and R0 resection. Hence, recurrence rate was lower than ERM therapy. This technique is actually performed routinely in Japan and experience is limited in Europe, with few data in the literature.
This study is suggested to patients with superficial medium or distal rectal tumors. The lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and chromoendoscopy. Then, marking around the lesions was performed. Local injection was made using injection needle, and then mucosal incision was performed around the lesion using endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel coagulation were practiced using primary hemostatic forceps during the procedure.
Follow-up is one year. For lesion with invasive carcinoma (vessel and lymphatic involvement, undifferentiated, free margin less than 1 mm), a surgical resection is performed.
All the patients have an endoscopic control 3 months after ESD (rectosigmoidoscopy with biopsies):
* For complete resection, an endoscopic control was performed at 1 year.
* For incomplete resection, another endoscopic therapy was attempted (EMR) an endoscopic control was performed at 1 year.
At one year, patient with incomplete resection have a surgical resection.
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