Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652672
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma SENTRY Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENTRY
Brief Summary:
The aim of this study is to reduce the need for segmental colonic resection and its associated morbidity and mortality in patients with high-risk pT1 and low-risk pT2 colon cancer following endoscopic resection by performing an endoscopic-assisted laparoscopicrobotic wedge resection of the residual tumor or scar along with sentinel node biopsy using indocyanine green ICG This intervention will be compared to the standard-of-care segmental resection using a partially randomized patient preference design The primary outcome is the 3-year recurrence rate
Detailed Description:
Colorectal cancer is the third most common type of cancer in the Netherlands and the second leading cause of cancer-related deaths An increased incidence of T1-T2 tumors has been observed following the introduction of population screening programs leading to more frequent endoscopic excisions The risk of lymph node metastasis in high-risk T1 and low-risk T2 colon cancers is relatively low However the diagnostic accuracy of abdominal CT scans for detecting lymph node metastasis is limited necessitating a formal segmental colonic resection to allow definitive nodal staging through pathological examination of the draining lymph nodes Nevertheless segmental resections following endoscopic excision of early-stage colon cancer will overtreat 85-95 of patients depending on the histological risk profile as the majority do not have lymph node metastases
Segmental colonic resections are associated with substantial morbidity Based on large population-based data 33 of patients experience at least one complication including anastomotic leakage with a postoperative mortality rate of 15-31 Morbidity is known to substantially impact quality of life and contribute to a high economic burden Additionally major symptoms of low anterior resection syndrome LARS is present in 21 of patients after segmental resection with reported effects on quality of life comparable to those experienced by patients who undergo rectal cancer resection and develop LARS
To reduce the number of segmental resections in early colon cancer risk stratification is applied based on histopathological examination of locally excised lesions In low-risk T1 cancer segmental resections are already omitted The risk of lymph node metastasis varies between 5-15 depending on the presence of one or more risk factors For low-risk T2 tumors the risk of lymph node metastasis ranges from 105-14 As a result the vast majority of patients still undergo surgery with potential harm but no benefit
The investigators hypothesize that in patients who have undergone R0R1Rx endoscopic excision of high-risk T1 or low-risk T2 colon cancer sentinel lymph node SLN biopsy combined with wedge resection of the residual tumor or scar can safely spare the majority of patients with negative SLNs from undergoing segmental resection For reliable identification of high-risk features endoscopic resection with pathological examination of a complete specimen is required therefore only patients who have had endoscopic resection will be included in this study In our systematic review and meta-analysis the investigators found a pooled accuracy of 98 and a sensitivity of 80 for SLN detection in T1-2 colon cancer The investigatorsuse endoscopic submucosal injection of indocyanine green ICG at the tumor site which carries a low risk of intra-abdominal spillage that could hinder SLN identification
The SLN biopsy will be combined with an endoscopy-assisted wedge resection of the residual tumor or scar following endoscopic resection During the endoscopy-assisted wedge resection the surgeon first identifies and mobilizes the colon to facilitate the wedge resection A gastroenterologist then performs a colonoscopy to visualize the scar from the previously resected tumor With intraluminal endoscopic visualization the surgeon places a suture which allows for traction to position the linear stapler The gastroenterologist confirms complete inclusion of the scar and ensures lumen patency before the stapler is fired Endoscopy-assisted limited wedge resection is associated with low complication rates and is performed at a lower cost compared to laparoscopic segmental resection Since no anastomosis is created the risk of anastomotic leakage is eliminated This approach could reduce morbidity mortality hospital stay and stoma rates Although staple line failure and leakage are theoretical risks such complications have not been reported in previous cases
Patients with a positive SLN macro- or micrometastasis are offered segmental resection with adjuvant chemotherapy SLN-negative patients do not undergo further surgery and are managed with an intensive follow-up strategy A conservative estimate of 80 sensitivity and an average of 10 lymph node metastases results in a 2 risk of retained positive nodes after SLN biopsy Additionally tumor deposits TDs could potentially be missed when patients are treated with the SLN biopsy and wedge resection However only 045 of patients with stage I disease are TD-positive The investigators consider the absolute risks of missed lymph node metastases and TDs acceptable given the reduced perioperative morbidity and mortality associated with segmental colectomy
The SENTRY trial will be the first to offer organ-sparing surgery combined with a SLN biopsy for patients with early-stage colon cancer following endoscopic resection This organ-sparing approach is anticipated to improve postoperative mortality morbidity hospital stay quality of life and costs compared to standard segmental resection without compromising oncological outcomes This multicenter partially randomized patient preference trial will compare the organ-sparing approach to the standard of care segmental resection to assess oncologic safety
Segmental colonic resections are associated with substantial morbidity Based on large population-based data 33 of patients experience at least one complication including anastomotic leakage with a postoperative mortality rate of 15-31 Morbidity is known to substantially impact quality of life and contribute to a high economic burden Additionally major symptoms of low anterior resection syndrome LARS is present in 21 of patients after segmental resection with reported effects on quality of life comparable to those experienced by patients who undergo rectal cancer resection and develop LARS
To reduce the number of segmental resections in early colon cancer risk stratification is applied based on histopathological examination of locally excised lesions In low-risk T1 cancer segmental resections are already omitted The risk of lymph node metastasis varies between 5-15 depending on the presence of one or more risk factors For low-risk T2 tumors the risk of lymph node metastasis ranges from 105-14 As a result the vast majority of patients still undergo surgery with potential harm but no benefit
The investigators hypothesize that in patients who have undergone R0R1Rx endoscopic excision of high-risk T1 or low-risk T2 colon cancer sentinel lymph node SLN biopsy combined with wedge resection of the residual tumor or scar can safely spare the majority of patients with negative SLNs from undergoing segmental resection For reliable identification of high-risk features endoscopic resection with pathological examination of a complete specimen is required therefore only patients who have had endoscopic resection will be included in this study In our systematic review and meta-analysis the investigators found a pooled accuracy of 98 and a sensitivity of 80 for SLN detection in T1-2 colon cancer The investigatorsuse endoscopic submucosal injection of indocyanine green ICG at the tumor site which carries a low risk of intra-abdominal spillage that could hinder SLN identification
The SLN biopsy will be combined with an endoscopy-assisted wedge resection of the residual tumor or scar following endoscopic resection During the endoscopy-assisted wedge resection the surgeon first identifies and mobilizes the colon to facilitate the wedge resection A gastroenterologist then performs a colonoscopy to visualize the scar from the previously resected tumor With intraluminal endoscopic visualization the surgeon places a suture which allows for traction to position the linear stapler The gastroenterologist confirms complete inclusion of the scar and ensures lumen patency before the stapler is fired Endoscopy-assisted limited wedge resection is associated with low complication rates and is performed at a lower cost compared to laparoscopic segmental resection Since no anastomosis is created the risk of anastomotic leakage is eliminated This approach could reduce morbidity mortality hospital stay and stoma rates Although staple line failure and leakage are theoretical risks such complications have not been reported in previous cases
Patients with a positive SLN macro- or micrometastasis are offered segmental resection with adjuvant chemotherapy SLN-negative patients do not undergo further surgery and are managed with an intensive follow-up strategy A conservative estimate of 80 sensitivity and an average of 10 lymph node metastases results in a 2 risk of retained positive nodes after SLN biopsy Additionally tumor deposits TDs could potentially be missed when patients are treated with the SLN biopsy and wedge resection However only 045 of patients with stage I disease are TD-positive The investigators consider the absolute risks of missed lymph node metastases and TDs acceptable given the reduced perioperative morbidity and mortality associated with segmental colectomy
The SENTRY trial will be the first to offer organ-sparing surgery combined with a SLN biopsy for patients with early-stage colon cancer following endoscopic resection This organ-sparing approach is anticipated to improve postoperative mortality morbidity hospital stay quality of life and costs compared to standard segmental resection without compromising oncological outcomes This multicenter partially randomized patient preference trial will compare the organ-sparing approach to the standard of care segmental resection to assess oncologic safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None