To evaluate the sensitivity of second-look endoscopic biopsies from the polypectomy site for residual adenocarcinoma in the surgical resection specimen.To register patients in whom exclusion criteria exist, in order to prospectively evaluate the…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity of second-look biopsies from the polypectomy site for residual
tumor in the resected bowel. Sensitivity is determined by the number of
tumor-positive biopsies divided by the number of tumor positive resection
specimens.
Secondary outcome
* 90-day mortality after rescue surgery: the number of patients that died
within 91 day after the operation for presumed residual adenocarcinoma*
* The sensitivity of biopsies for residual cancer in the bowel wall: the number
of patients with endoscopic biopsies containing adenocarcinoma divided by the
number of patients with adenocarcinoma in the resected bowel wall (regardless
of regional lymph nodes)*
* The number of complications (defined according to GCP) after biopsies from
the polypectomy: the number of patients with bleeding or perforation after
taking biopsies from the polypectomy scar, requiring at least prolongation of
treatment, or admission to hospital, or delay or speeding up rescue surgery.
This up until the moment of surgery.
* The sensitivity of global endoscopic assessment of initial polypectomy as
well as scar biopsies for residual cancer: the number of patients in whom the
endoscopic resection was assessed as incomplete and who also have residual
cancer in the surgically resected specimen divided by the total number of
patients in whom the endoscopic resection was judged to be incomplete.
* The proportion of patients with residual cancer in the resected specimen if
malignancy was unsuspected during the endoscopic polypectomy: the number of
patients in whom the malignancy was initially unsuspected during endoscopic
polypectomy and who also have residual cancer in the surgical specimen divided
by the total number of patients in whom the malignancy was initially
unsuspected during endoscopic polypectomy.
* The prevalence of residual tumor at operation and postoperative morbidity and
mortality in patients in whom exclusion criteria are applicable, and there for
are not eligible for taking biopsies.
Background summary
Since the introduction of a nation-wide screening program on large bowel
cancer, the number of endoscopically resected malignant colorectal polyps is
increasing.
Unfortunately, oncological radicality is usually impossible to guarantee after
endoscopic resection. Hence, additional surgical resection is carried out in a
considerable number of patients.
However, in 80% of these surgical resection specimens no residual
adenocarcinoma is found, nor in the bowel wall, nor in regional lymph nodes.
Evidently, the endoscopic resection was sufficient. One could state that these
patients have been operated in vain and that they have been exposed to
considerable postoperative morbidity and mortality risks (especially in the
elderly patient).
Study objective
To evaluate the sensitivity of second-look endoscopic biopsies from the
polypectomy site for residual adenocarcinoma in the surgical resection specimen.
To register patients in whom exclusion criteria exist, in order to
prospectively evaluate the results of operations in the Netherlands.
Study design
Prospective cross-sectional design using a multi-center approach. Patients
consenting to participation will have an endoscopy shortly before operation
(preferably in the operating room) to take biopsies from the polypectomy site.
The results of biopsies are compared to the resected bowel.
Patients in whom biopsies have no added value, will only be registered.
Study burden and risks
Depending on the situation of the patiënt, the following may occur:
1. A second endoscopy needs to be done to tattoo the polypectomy site, or for
endoscopic full-thickness resection. Participation is no extra burden. The
taking of biospies is painless and takes only a few minutes.
2. No second endoscopy would be needed (regular surgery, TEM, TAMIS,
polypectomy site already tattooed). Participation implies a second endoscopy.
Depending on the site where the polyp has been removed, the following types of
endoscopy may apply:
A. For distal tumors: a sigmoidoscopy. This implies distal bowel prep with two
enemas, investigation without conscious sedation in outpatient setting.
B. For tumors proximaal to the sigmoid: colonoscopy. This implies a full bowel
prep, investigation under conscious sedation and daycare admission.
The above mentioned situation is only applicable for patients having
laparoscopic or transabdominal surgical resection.
The risk of a second endoscopy are generale perceived as extremely small: the
endoscopy is only done to go to the polypectomy place and to take biopsies. The
risk of perforation or bleeding are estimated to be below 1: 5000. Again, if
risk are perceived to be elevated on the basis of the recent experience with
the colonoscopy, the patient will not be included.
Patients in whom exclusion criteria exist, will only be registered without any
intervention.
Nico Bolkesteinlaan 75
Deventer 7416 SE
NL
Nico Bolkesteinlaan 75
Deventer 7416 SE
NL
Listed location countries
Age
Inclusion criteria
All of the following criteria should be fulfilled:;1. Age 18 or above.
2. Endoscopically removed colorectal lesion with the following pathological characteristics:
a. A moderately to well-differentiated adenocarcinoma.
b. In case of an en-bloc resection: distance between adenocarcinoma and vertical or lateral resection
margin is less than 1 mm.
c. In case of piecemeal resection: unjudgeable radicality (mostly due to loss of orientation and multiple
fragments).
d. Absence of, or unjudgeable lymphatic or vascular invasion.
e. No tumor budding (only if specifically mentioned in the pathology report).
f. No deep (> 1mm) submucosal infiltration.
3. No suspicion of dissemination on the following investigations: serum carcino-embryonic antigen,
computer tomographic (CT) scan of the abdomen and a chest X-ray; in case of a rectal tumor (less
than 15 cm from the anal verge): magnetic resonance imaging of the rectum.
4. Operation (including local transmural excision by TEM, TAMIS or eFTR*) is advised in agreement
with the Dutch Guideline on Colorectal cancer and has been planned and agreed on by the
patient.
5. Written informed consent is obtained.;*TEM: Transanal Endoscopic Microsurgical excision
TAMIS: TransAnal Minimal Invasive Surgery
eFTR: Endoscopic Full-Thickness Resection
Exclusion criteria
1. Pathology shows one or more of the following characteristics:
a. A radical en-bloc resection with a free vertical and lateral margin of * 1 mm.
b. A poorly differentiated or signet-cell containing adenocarcinoma.
c. Lymphatic or vascular invasion (if this feature is unjudgeable due to piecemeal resection, no
exclusion is done).
d.Tumor budding (only if specifically mentioned in the pathology report)
f. Deep (> 1 mm) submucosal infiltration
2. Suspicion of dissemination on investigations as mentioned in the inclusion criteria
3. Patients already receiving anti-tumor treatment (including radiotherapy for rectal cancer) for another tumor or a synchronic colorectal cancer
4. Patients in whom a second-look endoscopy would require major and unacceptable effort and / or
resources, for instance clinical admission for bowel preparation, long travel, general anesthesia,
extremely difficult to reach polypectomy site.
5. Patient is not planned for endoluminal local resection (TEM, TAMIS, eFTR)*, or standard surgery.
6. Patient is pregnant.
7. Patient does not provide written informed consent or is unable to provide such.;*TEM: Transanal Endoscopic Microsurgical excision
TAMIS: TransAnal Minimal Invasive Surgery
eFTR: Endoscopic Full-Thickness Resection
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02328664 |
| CCMO | NL51461.078.15 |