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We collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA.

SA was carried out in a sitting position, following a strictly aseptic technique. After recognition of L2-L3 intervertebral space through landmark technique, a 25 Gauge needle was inserted and the correct positioning was confirmed by detecting free flow of cerebrospinal fluid. Subsequently, 10-12 mg of hyperbaric bupivacaine + sufentanil 2 mcg according to the decision of the anesthetist was administered intrathecally without barbotage.

Subsequently, the patient underwent ESD of the colorectal lesion.

endoscopic submucosal dissection of large colorectal lesions under spinal anesthesia

ESD of large LSTs under SA

Mauro Manno, MD

The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS).

Background and study aim: Endoscopic submucosal dissection (ESD) of large colorectal lesions requires the patient to be in a still position for a long time. Both deep sedation and general anesthesia carry a substantial risk of anesthesia-related adverse events (ARAEs), especially in frail patients. Conversely, mild-to-moderate sedation does not prevent involuntary movements of the patient. Spinal anesthesia (SA) is a safe and simple technique that provides analgesia and motor block without systemic drug administration or orotracheal intubation. As the use of SA in colorectal endoscopic resections has not been described so far, we aimed to evaluate the feasibility and performance of SA in large (\>35 mm) recto-sigmoid lesion ESD.

Patients and methods: The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS). The secondary endpoints were as follows: intra- and post-procedural need for additional opioid or other analgesic drug administration, ESD-related adverse eventss, length of hospital stay, and median ESD duration.

Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia

Technical success was defined as completion of the ESD under SA without the need of conversion to deep sedation or general anesthesia.

Safety was evaluated intra- and post-procedurally by recording anesthesia-related adverse events (ARAEs). Major ARAEs included death, anaphylaxis and severe cardiorespiratory or neurologic AEs. Minor ARAEs included any other cardiorespiratory or neurologic AEs, headache, acute urinary retention and itching.

Intra- and post-procedural need for additional opioid or other analgesic drug administration

Perforation, bleeding, post-coagulation syndrome, adverse events related to endoscopic bowel preparation

Azienda USL Modena

Directore Gastroenterology and Endoscopy Unit

Laterally Spreading Tumors (LST) are important precursosrs of invasive colorectal cancer. Endoscopic treatment has replaced surgery in most of the cases. Nevertheless, after conventional Endoscopic Mucosal Resection (CER), Local Residual Neoplasia (LRN) is an issue. Therefore, endoscopic follow-up and treatment are necessary. To decrease its occurrence, the risk factors of LRN shoudl be identified. Thereafter, in high-risk patients, other modalities of initial treatment including Endoscopic Submucosal Dissection (ESD) and surgical treatment, could be considered. The purpose of this prospective study is to identify risk factors associated with the presence of LRN after CER of LSTs.

Risk Factors for Residual Neoplasia After Endoscopic Mucosal Resection

Risk Factors for Local Residual Neoplasia After Convetional Endoscopic Mucosal Resection of Laterally Spreading Tumors

LRN was defined as a histologically confirmed neoplastic tissue in the biopsy samples obtained from post-resection scar during follow-up colonoscopy 3 months after endoscopic resection

Evaluation of selected patient- and lesion-related risk factors associated with LRN (gender, age, lesion size, location, morphology, pit pattern, histology, type of resection, and others)

Vitkovice Hospital

Investigator

Symptoms and General Pathology

Recurrence

Adenoma

Colonic Polyps

Polyps

Pathological Conditions, Anatomical

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Polyps

Herbal and Botanical

Cola

Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.

Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.

Hybrid APC

John Levenick, MD

The purpose of this study to evaluate and examine whether use of Hybrid Argon Plasma Coagulation (APC) as an adjunct to endoscopic mucosal resection (EMR) will reduce the risk of residual or recurrent neoplasia at 6 months. Hybrid APC is an existing FDA approved device used to assist with ablation of abnormal tissue anywhere in the GI tract.

Colon Cancer is a major disease that effects more than 1 million people per year globally. Adenomatous polyps have been identified as the main precursor leading to colorectal cancer. Colon cancer screening is the best way to detect and remove large, often asymptomatic polyps. Early detection and resection of these colorectal polyps can prevent the development of colon cancer. Endoscopic mucosal resection (EMR) is a technique used for resection of medium to large colon polyps. In this technique, fluid is injected into the submucosa creating a cushion between the mucosa and the muscularis propria. An electrocautery snare is then deployed to resect the polyp in a single (en-bloc) or multiple (piecemeal) pieces. Most polyps \>2 cm are resected in piecemeal way. Although EMR is now considered standard of care with a successful resection rate of 85 % and low risk of complication (3-10% bleeding and 1% perforation), this technique has inherent deficiencies, especially piecemeal EMR. Recurrence rates following piecemeal EMR can be as high as 20%. Resection of scarred polyps using this technique is particularly challenging due to the non-lifting of the polyp. Endoscopic submucosal dissection (ESD) is an alternative approach that aims to remove non- pedunculated precancerous or cancerous lesions over 20 mm in one piece (en-bloc resection rate of 89.95% and lesion recurrence rate of 0.7%). However, due to its technical complexity and high complication risk (mainly bleeding and perforation, with complication rates approximately 8%), it is not the current standard of care and only performed by experts in the technique.

Hybrid Argon plasma coagulation (APC) is a new technique in which the endoscopist reinjects the submucosa with fluid to create a cushion (normal saline/ diluted adrenaline and /or sodium hyaluronate solution) to protect the muscle layer and then ablation is done using spray argon coagulation to treat any microscopic residual disease that is the seed for local recurrence. Previous studies have shown that this technique is a safe and easily applicable technique to complete resection for recurrent polyps after first EMR.

Investigators hypothesize that with Hybrid APC assisted EMR there will be a decrease in recurrence rate after 6 months and it will be more effective compared to the standard EMR procedure.

This is a pilot study in which patients with non-pedunculated large polyps ≥ 20mm undergoing endoscopic mucosal resection (EMR) will be recruited. Following standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease. Resected polyps will be sent to the pathology laboratory where pathologist determine the final diagnosis of the polyps as per standard of care.

This is a pilot study design in which patients with non-pedunculated large polyps ≥ 20mm undergoing EMR will be recruited. Following standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation (APC) of the base edges of the polypectomy site to fulgurate any potential microscopic residual disease.

Following Standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.

Hybrid APC Assisted EMR for Large Colon Polyps

Hybrid APC Assisted EMR for Large Colon Polyps to Reduce Local Recurrence : A Prospective Data Collection Study

The primary outcome of interest will be the percentage of participants having complete resection at 6 months.

The secondary outcome of interest will be measure of major adverse event rate, mainly post-polypectomy bleeding and post-polypectomy syndrome

Milton S. Hershey Medical Center

Assistant Professor of Medicine

Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.

Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Included polyps were a median size of 27 mm (IQR: 14.5 mm) and predominantly located in the ascending colon (31.8%), cecum (25.0%), and transverse colon (20.5%).

Measurement of polyps in mm

Participant population was 10% (n=4) African American and 90% (n=36) with 100% (n=40) non-Hispanic/Latino population

Dr. John Levenick

Hybrid APC ( Erbe Hybrid APC) design for ablation of abnormal tissue in GI tract.

Hybrid APC: Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.

0% of recurrence in 32 cases who completed post-procedure colonoscopy 6 month follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia	NCT06316401	Colorectal (Col...	ESD of large LS...	18 Years -	Azienda USL Modena
Risk Factors for Residual Neoplasia After Endoscopic Mucosal Resection	NCT01478919	Colorectal Canc...		18 Years -	Vitkovice Hospital
Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia	NCT06316401	Colorectal (Col...	ESD of large LS...	18 Years -	Azienda USL Modena
Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia	NCT06316401	Colorectal (Col...	ESD of large LS...	18 Years -	Azienda USL Modena
Hybrid APC Assisted EMR for Large Colon Polyps	NCT03390907	Colon Polyp Colon Adenoma Colon Cancer	Hybrid APC	18 Years - 89 Years	Milton S. Hershey Medical Center
Risk Factors for Residual Neoplasia After Endoscopic Mucosal Resection	NCT01478919	Colorectal Canc...		18 Years -	Vitkovice Hospital

Spots Global Cancer Trial Database for laterally spreading tumor