Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rectal Neoplasms

Adenocarcinoma

Pathologic Complete Response

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Disease Progression

Disease Attributes

rectal resection

Many data suggest that patients with low rectal adenocarcinoma who achieved ypT0N0 status have improved survival and disease-free survival (DFS) compared to all other stages however only few data are available regarding the specific prognosis factors of this subgroup. This retrospective multicentric study aimed to predict the prognosis of patients with complete pathological response after neoadjuvant treatment.

Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma

A postoperative local recurrence was defined by biopsy-proven or radiographic evidence of local recurrent disease.

A postoperative distant recurrence was defined by biopsy-proven or radiographic evidence of distant recurrent disease.

Disease free survival was defined as the period between the day of surgery and the date of recurrence or the last date of follow-up

Moroccan Society of Surgery

Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer

loop ileostomi

Mark Ellebæk, MD

Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

The aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer.

Early closer is defined as postoperative days 8-12 and delayed as later then 3 months.

Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma.

A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. The patients will be randomized after the "intention-to-treat" principle, before the primary operation.

If there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed.

Primary end point is the rate of either postoperative death or postoperative complications occurring at 90 days after the rectal resection.

Major and minor postoperative complications (anastomotic leakage, post operative death, anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related complications (prolapsus or peristomial eventration, erosive peristomal dermatitis, dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered.

LARS score and EORTC QLQ-30 will be sent preoperatively and after 3, 6, 12 and 24 months postoperatively.

Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Death occurring during the first 90 postoperative days

Odense University Hospital

Doctor

Anastomotic Leak

Postoperative Complications

All patients who will fulfill the inclusions criteria. Patients will undergo formal curative radical Laparoscopic resection for rectal cancer

Formal curative radical laparoscopic rectal resection.

Laparoscopic resection for rectal cancer

Mostafa Shalaby, M,D., MSc.

Anastomotic leak (AL) is a breakdown of a suture line in a surgical anastomosis with a subsequent leakage of the luminal content. Anastomotic leakage occurs commonly in rectal and esophageal anastomosis than the other parts of the alimentary tract due to technical difficulties in accessing these areas and their easily compromised blood supply.

Anastomotic leakage is the most feared complication following rectal resection and anastomosis. The incidence of anastomotic leakage ranges from 2.8% to more than 15%, with mortality rate more than 30%. Subclinical anastomotic failure may occur in up to 51% of patients.

Anastomotic leakage leads to increase the rate of secondary interventions, re-operations, longer postoperative hospital stay, increased cost, and major impact on the patient's quality of life. In the medium to long term, patient may be unfit for post-operative adjuvant therapy with decreased the disease survival. Furthermore anastomotic leakage itself may increase the local recurrence, a reduction in overall survival, and a large proportion of patients are left with a permanent stoma.

Study populations: all patients will sign an informed consent prior to the surgery to be included in the study, after explanation of the nature of the disease, possible treatment, and the possibility of stoma formation.

Data recording: basic demographic data are recorded including age and sex of the patient as well as detailed information on history, risk factors, preoperative diagnostics, surgical procedure, intraoperative findings, histopathological work-up, and postoperative course.

Variables analysis: the variables are divided into patient-related, tumor-related, therapy-related, and techniques-related variables.

Preoperative workup: all patients will have detailed clinical history and physical examination including DRE. Routine laboratory investigations also are included e.g. CBC, blood glucose level, liver, and kidney function tests.

Regular workup for rectal cancer are included; full colonoscopy with biopsy, gastrografin/barium enema, TRUS evaluate degree of invasion of the rectal wall and regional lymph nodes, abdominal and pelvic CT scan, Chest x-ray or CT scan, CEA level, and EORTC Quality of life Questionnaire.

Level of the tumor: is measured from the lower border of the tumor to the anal verge by the rigid sigmoidoscope; considering it low \< 6 cm, middle 6-12 cm, and upper \> 12 cm.

Preoperative preparation: all patients will have preoperative mechanical bowel preparation and adequate thromboembolic prophylaxis. Prophylactic antibiotics will be given 30 - 60 minutes before surgery. A surgeon or stoma therapist will mark the site of the stoma before the operation in all patients.

Level of the anastomosis: is measured from the anastomosis to the anal verge by the rigid sigmoidoscope intraoperative; considering it low \< 10 cm, middle 10-15 cm, and upper \> 15 cm.

The rectal anastomosis is tested intraoperative with: trans-anal air insufflation with the pelvis immersed with saline to detect bubbles, trans-anal introduction of dye, or competence of donuts in stapled anastomosis.

Postoperative follow up:

Access the postoperative condition locally and systemically by bedsides clinical parameters, and usual blood tests like leucocyte count and CRP level at the 3rd and the 7th day postoperative.

Radiological follow up by Gastrografin enema around the 10th day or before dismissal from the hospital. Abdominal and pelvic CT scan is ordered in patients with clinical deterioration, abnormal abdominal findings, and turbid drainage secretion.

Peritoneal samples are collected from the abdominal drains at the first, third, and fifth days postoperatively for peritoneal microbiological study and cytokines (IL-6, IL-10, and TNF) level measurement.

Patients will receive a Quality of Life questionnaire (EORTC 30, 38) preoperatively, 30 days postoperative, and 30 days after stoma closure in case of diversion.

Follow up of patients continue till discharge, and 30 days postoperative. In cases with diversion follow up will continue till closure of stoma and 30 days after closure. Stoma closure in an uneventful course will be scheduled 8-10 weeks after the primary operation.

Diagnosis of leakage:

1. Fecal secretion via indwelling abdominal drainage, surgical wound or vagina.
2. Radiological via fluid collection adjacent to anastomosis associated with extraluminal contrast extravasation.

Classification of leakage: patients classified according to leakage into:

1. Non leakage group.
2. Leakage group, radiological is asymptomatic and detected on imaging, localized is diagnosed on radiological findings of a pelvic collection and clinically do not require a laparotomy or laparoscopy, and generalized is confirmed at laparotomy or laparoscopy.

Outcomes:

Primary outcomes:

Incidences of anastomotic leakage following laparoscopic resection for rectal cancer.

30 day's postoperative morbidity and mortality. secondary outcomes: The role of diversion on prevention of anastomotic leakage, are patients with diversion have low incidences of leakage.

Management of anastomotic leakage. Effect of anastomotic leakage on oncological outcome, assessment of local recurrence after 24 months follow-up.

Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer

Incidence of anastomotic leakage in patients who underwent laparoscopic resection of rectal cancer. This including clinical and sub-clinical (radiological diagnosis) leakage.

Do the patients with diversion have low incidences of anastomotic leakage compared to those without.

The comparison of conservative, radio-logical, or surgical options.

For patients who complete 24 months of follow-up for local recurrence.

University of Rome Tor Vergata

Mansoura University

Recurrence

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Herbal and Botanical

Oxaliplatin

Leucovorin

Fluorouracil

Capecitabine

Cola

Patients underwent anterior or low anterior resection. Patients with tumors in the lower third of the rectum where anal sphincters could not be preserved underwent abdominoperineal resection. In majority of the cases, inferior mesenteric artery (IMA) was ligated caudal to the origin of the left colic artery. For the tumors of the upper rectum, partial excision of the mesorectum was performed up to the minimum of 5 cm from the inferior aspect of the tumor. For the tumors of the middle and low rectum a total mesorectum excision was done with the minimum distal mucosal margin of 1 to 2 cm. Ileostomy was performed in cases where colon was poorly prepared, anastomotic leak test was positive or colonel anastomosis was made. In most of the cases, open surgery was performed. Laparoscopic surgery was performed in selected cases. Wide local excision was performed in selected cases with T1 tumors without locoregional lymphadenopathy.

Rectal resection

Patients with locally advanced disease (T3, T4) or lymph nodal positive disease were offered neoadjuvant therapy. In the neoadjuvant therapy, we used 45 Gy in 25 fractions with concurrent 5-fluorouracil \[5-FU\] and patients were operated 8 to 10 weeks after neoadjuvant therapy. In some cases, especially the elderly patients with multiple co-morbidities, we used short-course pelvic radiation therapy which included 25 Gy in 5 fractions over 1 week.

Neoadjuvant therapy

Patients with locally advanced disease (T3, T4) or lymph nodal positive disease were offered adjuvant therapy. In most of the cases, FOLFOX (leucovorin, 5-FU, oxaliplatin) regimen was used and for elderly patients who could not tolerated this regimen, we used oral capecitabine.

Adjuvant therapy

Colorectal cancer is one of the most frequently diagnosed cancers and a major cause of cancer deaths worldwide. Recurrence after curative surgery is one of the major factors affecting the long-term survival and its frequency is estimated to be 22.5% at 5 years. of which 12% have local recurrence. The overall survival in case of recurrence of 11% at 5 years.

Several patient-, tumor-related and treatment-related prognostic factors have been found to be associated with the risk of recurrence of rectal adenocarcinoma. Some of these factors such as TNM stage, lymphatic and perineural invasion and vascular emboli have been found to affect recurrence free survival in most studies. While the impact of other factors such as distal resection margin, tumor size, extra capsular spread and neoadjuvant chemoradiotherapy on recurrence remains controversial. Moreover, most of the previous studies on prognostic factors have been from American and European countries with very little data from African countries. Recognition of these factors helps in identification of high-risk patients who require close and more rigorous postoperative surveillance. Hence this study was conducted to determine the factors affecting recurrence after curative resection of rectal cancer in African population.

Factors Predicting Recurrence in Rectal Cancer After Surgery

Factors Predicting Recurrence After Curative Resection for Rectal Cancer: a 16-year Study

the development of any new malignant lesion within the field of surgery (locoregional recurrence) or outside it (distant metastasis) after initial resection was judged to be curative (R0) based on the preoperative imaging and histopathological examination of the resected specimen.

ammar houssem

Surgeon

Surgery after ≤ 42 days from the end of neoadjuvant radio-chemotherapy

Surgery after 43-56 days from the end of neoadjuvant radio-chemotherapy

Surgery after 57 or more days from the end of neoadjuvant radio-chemotherapy

Low Anterior Resection and Abdominoperineal Resection

Rectal Resection

Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal tumours. Ideal time interval between the end of NRCT and surgery is still debated; a 6-8 weeks time interval is considered optimal, but shorter or longer intervals have been associated with better oncological outcomes. Moreover, there is a lack of data about clinical postoperative outcomes and different time intervals after the end of NRCT. Here, effect that different time intervals have on postoperative complications with particular regard to the anastomotic dehiscence have been evaluated.

Methods One hundred-sixty-seven patients underwent surgery after long-course NRCT. Three different time intervals were considered: (0-42; 43-56; \>57 days).

Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal adenocarcinoma. Even though a 6-8 weeks' time interval after the end of NRCT and surgery is considered ideal, the optimal time for surgery is still controversial.

Outcomes of Resection at Different Times Between the End of Neoadjuvant Treatment and Surgery

Evaluation of Anatomopathological, Oncological and Surgical Outcomes in Relation to the Different Times Between the End of Neoadjuvant Treatment and Surgery

Campus Bio-Medico University

Principal Investigator

Observation

Ivan Cecconello, MD

Ulysses Ribeiro, MD

With the possibility of pathological complete response in surgical specimens, some authors have proposed non-operative management of the patient group, when re-staged after neoadjuvant treatment, have complete clinical response. So far, this approach remains discussed in the literature, and there are still many uncertainties that patients with clinical complete response after chemoradiotherapy in fact no detectable viable tumor and may be omitted of radical surgical treatment. It is a still investigational approach and actually gained space even for patients with very high or who refuse surgery after all clarifications surgical risk.

Hypothesis: The preservation of the rectum in patients with adenocarcinoma of the middle and distal rectum (up to 10 cm) reaching clinical complete response after neoadjuvant chemoradiotherapy have similar rate of the rectal cancer recurrence than patients who underwent surgical rectal resection.

This will be a prospective, randomized, open label phase II of surgical resection versus conservative treatment (observation) in patients with mid and distal rectal cancer who achieved complete after neoadjuvant chemoradiotherapy combined with clinical response.

The main objective of this study is to assess whether conservative approach is similar to rectosigmoidectomy with complete mesorectal excision or amputation abdminoperineal the rectum in patients with complete clinical response after neoadjuvant therapy combined chemoradiotherapy.

Patient Selection: To be eligible patients who have neoadjuvant prior histologic diagnosis of rectal adenocarcinoma, tumors located within 10 cm from the anal verge, a complete clinical response after treatment with chemoradiotherapy for rectal tumors staged clinical and radiological T3-4 N0 M0 or T (any) N + M0, absence of colorectal synchronous tumors.

Treatment: Eligible patients will be randomized 1:1 to resection of the rectum or notice. The period for randomization of patients will be 12 weeks after the last dose of radiotherapy / chemotherapy, so that we can properly assess the antitumor response as described above. After randomization, patients in the surgical group will undergo resection of the rectum with complete excision of mesorectal within 2 weeks after randomization.

Observation Versus Surgical Resection in Patients With Rectal Cancer Who Achieved Complete Clinical Response After Neoadjuvant Chemoradiotherapy

Open Randomized Study of Observation Versus Surgical Resection in Patients With Rectal Cancer Who Achieved Complete Clinical Response After Neoadjuvant Chemoradiotherapy

Instituto do Cancer do Estado de São Paulo

Neoplasm Metastasis

T1 and T2 rectal carcinoma operated on will be included in the study group. The first step will be a retrospective and exploratory analysis of FFPE slides retrieved from the pathology archives testing a panel of molecular marker exploring the immune reaction to the cancer (i.e. antigen presenting cells and T lymphocytes activation).

T1 and T2 rectal carcinoma operated on will be included in the study group. The second step will be a prospective and validating analysis. Tissue samples will be obtained from normal rectal mucosa adjacent to the cancer at the time of the trans anal or trans abdominal resection. In patients with early rectal cancer, the combination of immunological markers on healthy rectal mucosa adjacent to the cancer obtained in the part 1a of the study will be validated to identify the patients that will have not any nodal metastasis.

every patients will undergo to the appropriate rectal resection

Marco Scarpa, MD, PhD

ABSTRACT Background The current management on rectal cancer based on TNM staging has some limitations. In early rectal cancer T stage can be not sufficient to predict the nodal status and, in locally advanced rectal cancer after neoadjuvant therapy the persistence of a complete response to therapy cannot be accurately predicted by the simple tumor regression grade. For both cases the current guidelines recommend the complete rectal resection with a total mesorectal excision. The implications for patients' quality of life are evident even in case of sphincter sparing surgery. Moreover, in both cases the cancer sample available for the analysis can be small or inexistent.

Hypothesis The main hypothesis underlying our research is that the aggressiveness of rectal cancer is determined by the complex interactions between the malignant cells and their immune microenvironment. The second hypothesis is that relevant trace of this cross talk between tumor cells and immune microenvironment can be detected in the normal mucosa surrounding the cancer according to the concept of field cancerization.

Aims The aim of this project is to analyze the healthy rectal mucosa surrounding the cancer to identify traces of immunosurveillance mechanisms and of field cancerization and to use them to obtain a composite prognostic test to predict nodal metastasis in early rectal cancer and recurrence after complete response at neoadjuvant therapy in case of locally advanced rectal cancer.

Experimental Design This prognostic test will be constructed on the combinatory analysis of the transcriptome, immune and epithelial cells cross-talk, immune checkpoints and miRNA expression in normal rectal mucosa surrounding cancer. The aim is to predict the presence of nodal metastasis in patients with early rectal cancer. In step A, we will retrospectively analyze archival tissue samples in order to identify the most performing biomarkers; in step B, we will validate the prognostic performance of the markers identified in phase I through a prospective analysis of rectal mucosa specimen.

Expected Results The anticipated outcome of this project is to generate one or different combination of markers to optimize rectal management and to predict rectal cancer patients outcome more accurately than traditional TNM staging or tumore regression grade. We expect to obtain a prognostic test from normal tissue that accurately predicts rectal cancer behavior even in case when the tumor samples are scarce (early rectal cancer) or absent (complete response to therapy) to avoid unnecessary total rectal excision.

Impact On Cancer An immunoscore specific for rectal cancer may predict tumor progression and clinical outcome more accurately and may contribute to better design a personalized therapeutic algorithm. Moreover, nowadays patients with early rectal cancer without nodal involvement and patients with potential complete response to neoadjuvant therapy still undergo total rectal excision which is a risky procedure that impairs quality of life. The use of this new prognostic test may make possible to adopt a minimally invasive approach or even simple observation if nodal involvement or residual disease are reasonably excluded.

Background The introduction of new technologies for diagnosis and screening programs led to an increasing rate of early detection of colorectal cancer \[9\]. This, combined to the evolution of techniques of local excision, led to the development of new strategies to reduce treatment related morbidity, especially for early rectal cancer. In fact, transanal local excision has recently received attention as an alternative to radical surgery for early rectal cancer \[10\]. Nevertheless, the definition of early rectal cancer and its staging and treatment algorithm are still under debate \[9\]. In, fact, to minimize the recurrence rate after local excision of rectal cancer, the false-negative rate of nodal staging should be minimized \[11\]. MRI can be helpful to better identify candidates suitable for local excision of early stage rectal cancer. However, strict MRI criteria for oncologic safety might result in considerable false-positive cases and limit the application of local excision \[11\]. Therefore, different markers are warranted to overcome this critical point in early rectal cancer management. A recent Swiss study on 126 rectal biopsies analyzed with microarray aimed to investigate whether immunoprobing might help in predicting lymph node involvement in this subgroup. Their results suggested that in early rectal cancers absence of CD8+ T-cell infiltration helps in predicting patients' nodal involvement \[12\]. Last but not least, a recent systematic review provided data suggesting that selected patients with T1/T2N0M0 rectal cancer may undergo local excision without compromising the oncological outcome otherwise conferred by total mesorectal excision \[13\]. High risk patients (i.e. those with low CD8 infiltrate) might benefit of chemoradiation. In fact, while guideline-concordant adoption of local excision for treatment of low-risk stage I rectal cancer is increasing, its use is also increasing for higher-risk rectal cancers that do not meet guideline criteria.

Treatment with local alone is associated with poorer long-term OS and additional studies are warranted to understand risk factor of poor outcome after local excision \[14\].

Hypothesis The clinical question is how to predict the presence of nodal metastasis in patients with early rectal cancer. These patients may potentially benefit of a minimally invasive treatment, a trans anal resection, provided that the nodal status can be considered negative for metastasis.

Study design Tissue samples will be obtained from cancer tissue (if possible) and from normal rectal mucosa adjacent to the cancer at surgery. The very large number of patients need to answer the two questions imply a multicentric design. Complete medical record and follow-up will be collected from each center. The analysis will be centralized mostly in Azienda Ospedaliera di Padova. The study will be articulated in two parts each of them aiming to answer to one of the above described questions. Each part of the study will be articulated in a retrospective and exploratory step (A) and in a prospective validation step (B).

Healthy rectal mucosa sourrounding the rectal cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma	NCT03601689	Rectal Neoplasm...	rectal resectio...	18 Years -	Moroccan Society of Surgery
Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer	NCT01865071	Rectal Cancer	loop ileostomi	18 Years -	Odense University Hospital
Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer	NCT02718729	Anastomotic Lea...	Laparoscopic re...	-	Mansoura University
Factors Predicting Recurrence in Rectal Cancer After Surgery	NCT03899870	Rectal Cancer Rectal Adenocar...	Rectal resectio... Neoadjuvant the... Adjuvant therap...	-	Université de Sousse
Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer	NCT01865071	Rectal Cancer	loop ileostomi	18 Years -	Odense University Hospital
Anastomotic Leakage Following Laparoscopic Resection for Rectal Cancer	NCT02718729	Anastomotic Lea...	Laparoscopic re...	-	Mansoura University
Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma	NCT03601689	Rectal Neoplasm...	rectal resectio...	18 Years -	Moroccan Society of Surgery
Outcomes of Resection at Different Times Between the End of Neoadjuvant Treatment and Surgery	NCT04013347	Neoadjuvant Che... Rectal Tumor Surgery Surgery--Compli...	Rectal Resectio...	18 Years - 90 Years	Campus Bio-Medico University
Observation Versus Surgical Resection in Patients With Rectal Cancer Who Achieved Complete Clinical Response After Neoadjuvant Chemoradiotherapy	NCT02052921	Rectal Cancer	Rectal resectio... Observation	18 Years - 75 Years	Instituto do Cancer do Estado de São Paulo
IMMUNOlogical Microenvironment in REctal Adenocarcinoma Treatment	NCT04915326	Rectal Cancer S... Rectal Cancer N...	rectal resectio...	18 Years -	University of Padova
Factors Predicting Recurrence in Rectal Cancer After Surgery	NCT03899870	Rectal Cancer Rectal Adenocar...	Rectal resectio... Neoadjuvant the... Adjuvant therap...	-	Université de Sousse

Spots Global Cancer Trial Database for rectal resection