RU2578816C1 - Method for prevention of local recurrence in transanal endoscopic resection of rectum cancer - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention can be used for prevention of local recurrence after transanal endoscopic resection of rectum cancer in patients with initial forms of rectal cancer T1N0M0. For this purpose during the surgical intervention, after a full thickness resection of the intestinal wall with a part of mezorectal cellular tissue and removal of the preparation the mezorectal cellular tissue is infiltrated with 20 ml of ozonised physiologic saline in the ratio of 1000 mcg/l. Then a preparation of interferon alpha 1 is introduced into the mezorectal cellular tissue in the amount of 1 million IU. After that the mezorectal cellular tissue is sprayed with 1 g of capecitabine powder. Then, at the following stage, the rectal wall is closed in a standard way.

EFFECT: method provides for reduction of a rate of local disease recurrence.

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Description

The invention relates to medicine, namely to oncology, and can be used to reduce the frequency of local relapse after transanal endoscopic rectal resection for cancer.

For the first time, Professor Buess G. et al. Reported the use of a new method of transanal removal of benign tumors of the rectum using a system to provide microsurgical manipulations. in 1983 An advanced surgical rectoscope with stereoscopic optics, providing a good overview of the surgical field, and microsurgical instruments allowed the authors to successfully remove neoplasms of the lower and middle ampulla of the rectum.

Further application of the method showed that a complete visual control and microsurgical technique provide the ability to accurately remove tumors of any part of the rectum with an n-block, with adequate lateral boundaries around the circumference of the intestinal wall, with the possibility of excision at the level of the submucous layer, within the muscle, as well as throughout intestinal wall thickness.

A significant advantage of transanal endoscopic surgery is the organ-preserving nature of the surgical intervention, the preservation of the functional state of the rectum and its obturator apparatus, which allows preserving the patient's quality of life.

However, a decrease in the volume of tissues removed during organ-preserving surgery of transanal endoscopic rectum resection naturally leads to an increase in the number of local cancer relapses compared to more extensive surgical interventions - anterior rectal resection and abdominal-perineal extirpation of the rectum with total mesorectumectomy, in which the local relapse rate is 1.4% for pT1N0M0 tumors (Ptok N., Marusch R., Meyer F. et al. Oncological Outcome of Local vs Radical Resection of Low-Risk pT1 Rectal Cancer // Arch. Surg. 2007. No. 142 (7). P. 649-654).

According to several researchers with colorectal cancer Tis-T2N0M0, the relapse rate after transanal endoscopic surgery is 3.9% to 14-15% (see Lee W., Lee D., Choi S. et al. Transanal endoscopic microsurgery and radical surgery for T1 and T2 rectal cancer // Surg. Endosc. 2003. No. 17. P. 1283-1287; Lezoche E., Baldarelli M., De Sanctis A. et al. Early rectal cancer: definition and management // Dig. Dis. 2007. No. 25 (1). P. 76-79; Maslekar S., Pillinger SH, Sharma A. Cost analysis of transanal endoscopic microsurgery for rectal tumors // Colorectal Dis. 2007. No. 9 (3). P. 229-234). The relapse rate after transanal endoscopic surgery can reach 26% with pT1, and 35.4% with pT2, and increases significantly with lymphovenous tumor invasion and deep infiltration of the submucosal layer of the intestinal wall (see Ptok N., Marusch F., Meyer F. et al. Oncological Outcome of Local vs Radical Resection of Low-Risk pT1 Rectal Cancer // Arch. Surg. 2007. No. 142 (7). P. 649-654 .; Baatrup G., Breum B., Qvist N. et al Transanal endoscopic microsurgery in 143 consecutive patients with rectal adenocarcinoma: results from a Danish multicenter study // Colorectal Dis., 11 (3). 2009. P. 270-275; Bach SP, Hill J., Monson JRT et al. A predictive model for local recurrence after transanal endoscopic microsurgery for rectal cancer // British. J. Surgery. No. 96. 2009. P. 280-290; De Graaf EJ, Door nebosch P.G., Tollenaar R.A. et al. Transanal endoscopic microsurgery versus total mesorectal excision of T1 rectal adenocarcinomas with curative intention // Eur. J. Surg. Oncol. 2009. 35 (12). P. 1280-1285).

In order to reduce the recurrence rate after transanal endosurgical removal of a rectal tumor, a number of authors are conducting radiation therapy with effect (see Duek Simon D .. Issa Nidal, Hershko Dan D. et al. Outcome of Transanal Endoscopic Microsurgery and Adjuvant Radiotherapy in Patients with T2 Rectal Cancer // Dis. Colon. Rectum. 2008. No. 51. P. 379-384). Postoperative radiation therapy in debilitated elderly and senile patients after transanal endoscopic removal of cancer of the lower and middle ampulla of the rectum T1-2N0M0 showed good functional results, a small number of complications (5, 6%), and a low relapse rate during the 20-month observation period (in 1 of 18 patients).

However, a small number of observations that did not track the long-term results of the use of radiation therapy in transanal endoscopic removal of colorectal cancer do not allow recommending this treatment method for widespread use in clinical practice.

Local interstitial chemotherapy, which has its effect in the area of the removed tumor, can help solve this problem.

The well-known "Method for the treatment of liver metastases of the stomach and colon cancer" (see patent RU 2470675, Bull. No. 36 dated 12/27/2012, C2, A61M 1/36, A61K 31/513, A61K 35/16, A61P 35/04 ) The method consists in the fact that in the preoperative period, 200 ml of blood is taken from patients, autoplasma is isolated from the blood by centrifugation, 5 ml of autoplasma and chemotherapy are placed in the first bottle, and the remaining blood cells, plasma and chemotherapy are placed in the second bottle; separate incubated vials for 40 minutes at 37 ° C; then the operation is performed on the colon, from the beginning of the operation, the incubated shaped elements of blood with chemotherapy from the second bottle are injected dropwise; Then, radiofrequency thermoablation of metastases to the liver is performed under ultrasound control, after which an incubated autoplasma with chemotherapy from the first vial is introduced through the infusion pump in the electrosurgical device in the bed of the thermally degraded metastasis. The method is highly effective as a local interstitial chemotherapy, however, it can be used only after radiofrequency thermoablation of liver metastases, in addition, it requires preoperative preparation: autologous blood sampling, centrifugation and incubation with drugs, and the question of the appropriateness of interstitial chemotherapy may arise directly during surgery, transanal endoscopic rectum resection.

The technical result of our invention is to reduce the frequency of local relapses after transanal endoscopic rectal resection for cancer.

The technical result is achieved by the fact that during surgery - transanal endoscopic rectum resection for cancer, after a full-layer resection of the intestinal wall with part of the mesorectal fiber and removal of the drug, mesorectal fiber is infiltrated with 20 ml of ozonized physiological saline (1000 μg / l), then mesorectal fiber is injected with an interferon preparation, after which mesorectal fiber is pollinated with 1 gram of capecitabine powder; the next step is usually sutured wall of the rectum.

The invention "A method for preventing the development of local recurrence in transanal endoscopic rectal resection for cancer" is new, as it is unknown in the field of medicine in transanal endoscopic surgery of malignant tumors of the rectum, reducing the number of local relapses.

The novelty of the invention lies in the fact that during surgery - transanal endoscopic rectal resection for cancer, after a full-layer resection of the intestinal wall with part of the mesorectal fiber and removal of the drug, mesorectal fiber is infiltrated with 20 ml of ozonized physiological saline (1000 μg / l), then interferon is injected into the mesorectal fiber, after which 1 gram of capecitabine powder is pollinated the mesorectal fiber.

Thus, the prevention of local recurrence during surgery of transanal endoscopic rectal resection for cancer helps to reduce the incidence of local cancer recurrence due to interstitial ozone, immuno-and chemotherapy directly at the site of beneficial effect.

The method is as follows.

During surgery - transanal endoscopic rectal resection for cancer, after a full-layer resection of the intestinal wall with part of the mesorectal fiber and removal of the drug, mesorectal fiber is infiltrated with 20 ml of ozonized physiological solution (1000 μg / l), then an interferon preparation is injected into the mesorectal fiber, after which mesorectal fiber is pollinated with 1 gram of capecitabine powder; the next step is usually sutured wall of the rectum.

The invention "A method for preventing the development of local recurrence in transanal endoscopic rectal resection for cancer" is industrially applicable, as it can be used in medical institutions of oncological profile, dispensaries, and cancer research institutes.

We present clinical examples of the application of the “Method for the prevention of local recurrence in transanal endoscopic rectal resection for cancer.”

Example No. 1.

Patient K., born in 1950, was admitted to the Department of General Oncology of the Federal State Budgetary Institution “Rostov Scientific Research Cancer Institute” of the Ministry of Health of Russia on May 14, 2013 with complaints of blood in the stool. Considers herself ill for 4 months. During the examination: FCC from 04/12/2013. 13 cm from the anus along the posterior wall of the rectum tumor to 2 cm. Histological analysis No. 21430: adenocarcinoma. An abdominal corticotomy abdominal cavity on 12.04.2013 did not reveal any pathological changes.

Objectively: The patient's condition is relatively satisfactory. The skin and visible mucous membranes of normal color. Peripheral lymph nodes are not palpable. Pulse 82 per minute, blood pressure 120/80 mm RT. Art. Heart sounds are rhythmic, clear. In the lungs, auscultatory vesicular breathing on both sides, no wheezing. The tongue is wet, clean. The abdomen is not swollen, on palpation it is soft, painless. Rumbling in the lumbar region is painless on both sides. No peripheral edema. Finger examination of the rectum: up to 8 cm without pathology.

Diagnosed with cancer of the rectum T1N0M0, Art. 1, column 2.

Clinical and laboratory examination did not reveal significant deviations, preoperative preparation was standard. 05/16/2013, the patient was taken to the operating room. It was decided to perform transanal endoscopic rectum resection.

Stages of surgical intervention.

Under general anesthesia in the patient’s position on the back with legs spread apart, after processing the surgical field, a special surgical rectoscope manufactured by KarlStorz (Germany) was installed in the rectum, adapted to a standard laparoscopic stand, using devices for fixing it, an insufflator for pumping carbon dioxide gas into the rectum and a set of tools for endoscopic manipulations (high-frequency electrocoagulator, Harmonic coagulation scissors, tissue clamps, scissors).

An exophytic tumor was visualized 13 cm from the anus along the posterior wall of the rectum with a diameter of up to 2 cm. Having retreated from the edge of the tumor 1 cm, a full-wall excision of the rectum tumor within healthy tissues with excision of the adjacent mesorectal fiber was performed using a coagulator.

Mesorectal fiber is infiltrated with 20 ml of ozonized physiological solution (1000 μg / L), then interferon alpha 1 million ME is injected into the mesorectal fiber, after which mesorectal fiber is pollinated with 1 gram of capecitabine powder.

The rectal wall is sutured in the transverse direction by a continuous single-row suture (Polisorb, Monocryl 2/0), which was fixed along the edges with special clips (Lapra).

Postoperative pathomorphological study No. 27161/13: moderately differentiated adenocarcinoma with mucosal invasion.

The postoperative period was uneventful. The patient was discharged 7 days after surgery.

During dynamic observation of the patient for 18 months, no signs of tumor recurrence were detected.

The given clinical observation demonstrates the possibility of preventing the recurrence of colorectal cancer after organ-preserving surgery - transanal endoscopic rectal resection.

Example No. 2.

Patient Sh., Born in 1955, was admitted to the Department of General Oncology of the Federal State Budgetary Institution “Rostov Research Cancer Institute” of the Ministry of Health of Russia February 12, 2013 with complaints of an admixture of blood and mucus in the feces. Considers himself ill for 2 months. During the examination: FCC from 02/08/2013 9 cm from the anus along the posterior wall of the rectum tumor to 2.5 cm. Histological analysis No. 20541: adenocarcinoma. SRCT of the abdominal cavity on February 8, 2013 showed no pathological changes.

Objectively: The patient's condition is relatively satisfactory. The skin and visible mucous membranes of normal color. Peripheral lymph nodes are not palpable. Pulse 81 per minute, blood pressure 130/90 mm RT. Art. Heart sounds are rhythmic, clear. In the lungs, auscultatory vesicular breathing on both sides, no wheezing. The tongue is wet, clean. The abdomen is not swollen, on palpation it is soft, painless. Rumbling in the lumbar region is painless on both sides. No peripheral edema. Finger examination of the rectum: up to 8 cm without pathology.

Diagnosed with cancer of the rectum T1N0M0, Art. 1, column 2.

Clinical and laboratory examination did not reveal significant deviations, preoperative preparation was standard. 02/13/2013, the patient was taken to the operating room. It was decided to perform transanal endoscopic rectum resection.

Stages of surgical intervention.

Under general anesthesia in the patient’s position on the back with legs spread apart, after processing the surgical field, a special surgical rectoscope manufactured by KarlStorz (Germany) was installed in the rectum, adapted to a standard laparoscopic stand, using devices for fixing it, an insufflator for pumping carbon dioxide gas into the rectum and a set of tools for endoscopic manipulations (high-frequency electrocoagulator, Harmonic coagulation scissors, tissue clamps, scissors).

A saucer-like tumor was visualized 9 cm from the anus along the posterior wall of the rectum with a diameter of up to 2.5 cm. Having retreated from the edge of the tumor 1 cm, a full-wall excision of the rectum tumor within healthy tissues with excision of the adjacent mesorectal fiber was performed using a coagulator. The rectal wall is sutured in the transverse direction by a continuous single-row suture (Polisorb, Monocryl 2/0), which was fixed along the edges with special clips (Lapra).

Postoperative pathomorphological study No. 26181-3 / 13: moderately differentiated adenocarcinoma with mucosal invasion.

The postoperative period was uneventful. The patient was discharged 6 days after surgery.

Dynamic monitoring of the patient 10 months after surgery revealed a relapse of the tumor. The patient underwent anterior resection of the rectum.

The given clinical observation demonstrates the possibility of recurrence of colorectal cancer after organ-preserving surgery - transanal endoscopic rectal resection.

Under our supervision, there were 19 patients with initial forms of colorectal cancer T1N0M0 who underwent organ-preserving surgery - transanal endoscopic rectal resection. During the operation, 9 patients underwent prophylaxis of local recurrence according to the developed method, and 10 patients underwent standard transanal endoscopic rectal resection without intraoperative prophylaxis of local recurrence. Dynamic monitoring of patients during the year after surgery showed that in patients who, during transanal endoscopic rectal resection, were prevented local recurrence according to the developed method, no local recurrence of rectal cancer was detected during the year after surgery. In patients who underwent standard transanal endoscopic rectal resection without intraoperative prophylaxis of local recurrence, in 2 cases (20%) a local recurrence of colorectal cancer developed 8 and 10 months after surgery. At the same time, one patient underwent anterior rectal resection, and another patient underwent abdominal-perineal extirpation of the rectum with the removal of a permanent colostomy.

The results obtained allowed us to conclude that the use of the developed method for the prevention of local recurrence in transanal endoscopic rectal resection for cancer contributed to a 20% reduction in the rate of local recurrence in organ-preserving treatment of early rectal cancer.

The technical and economic efficiency of the "Method for the prevention of local recurrence in transanal endoscopic rectal resection for cancer" is that the use of the method reduces the incidence of local recurrence after transanal endoscopic rectal resection for cancer, is simple to implement. The method allows to reduce the cost of treating local relapses after organ-preserving surgery - transanal endoscopic resection of the rectum, to reduce the frequency of operations with excretion of the colostomy.

Claims (1)

A method for preventing the development of local recurrence in transanal endoscopic rectal resection for cancer in patients with initial forms of colorectal cancer T1N0M0, including surgical operation, characterized in that during surgery, after a full-layer resection of the intestinal wall with part of the mesorectal tissue and removal of the drug, mesorectal fiber is infiltrated with 20 ml of ozonized physiological solution of 1000 μg / l, then the preparation of interferon alpha 1 million ME is injected into the mesorectal fiber why mesorectal fiber is pollinated with 1 gram of capecitabine powder; the next step is usually sutured wall of the rectum.