Italian Study on the Right Hemicolectomy: How the Lymphadenectomy is Performed

Colon Cancer Clinical Trial

— CoDIG-2  

Official title:

Lymphadenectomy in Right Hemicolectomy: Italian Multicenter Study (CoDIG-2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05943951
• Other study ID #: CoDIG-2
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: July 2023
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the study is the analysis of lymphadenectomy in the course of right hemicolectomy, in relation to the radicality of the surgical resection that is performed. In particular, the investigators wants to inquire how according to precise standards regarding surgical radicalness and consequently the anatomical piece that is obtained it is possible to correlate a certain number of lymph nodes and their possible positivity.

The lead center is the General and Thoracic Surgery Department of the University of Ferrara. Prof. Anania is the responsible for the enrollment of patients and the coordination with the collaborating centers in the six month-study

Description:

All the high-volume specialist centres that perform this type of intervention in Italy will be invited, with a minimum number of 25 interventions per year. At the end of the study 788 patients was enrolled.

The data of the patients involved will be collected independently and anonymously by the individual centers involved, using a common alpha numeric code decided by the coordinating center.

The parameters examined will be:

• Personal data of the patient

• Stage of neoplasm due to surgery

• Type of surgery and duration

• Post-operative course

• Presence of post-surgical complications and eventual hospital readmission due to these complications

• Study of the operating piece and lymphadenectomy performed:

Tumor free margin Terminal ilium length The different vascular ligatures and levels at which they are performed Integrity of the mesocolon Number of positive nodes per total removed

Following the end of the 6 months of observational study period, the data will be processed anonymously at the coordinating centre.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 788
• Est. completion date: October 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Patients and/or legal guardians, where applicable, have been fully informed and have voluntarily provided informed written consent or patients unable to read and/or write who have fully understood the information verbally provided by the investigator and who have provided a verbal consent testified in writing by a third person.

• Patients aged > 18, men and women, operated by laparoscopic right hemiolectomy or video assisted, under election regime at the U.O. General and Thoracic Surgery with diagnosis of colic adenocarcinoma at any stage.

• Patients who have already undergone chemotherapy and radiotherapy for other reasons.

Exclusion Criteria:

• Under age.

• Patients undergoing emergency surgery.

• Women who are pregnant.

• Patients with right-handed laparotomy

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Lymph Node Metastasis
• Lymphatic Metastasis
• Surgical Procedure, Unspecified

Intervention

Procedure:
• Right hemicolectomy
It begins with a thorough laparoscopic inspection of the abdomen for evidence of metastatic disease and to confirm the location of the tumor. Usually is performed dissection using a medial-to-lateral approach. A lateral or inferior approach can also be used depending on the anatomy. The vascular dissection may begin at the ileocolic pedicle or over the superiore mesenteric vein. After completing the medial-to-lateral dissection, the sourgeons return to the ileocolic pedicle to begin vascular dissection. Whether a D2 (until encountering the right branch of the middle colic) or D3 dissection (until the root of ileocolic artery and vein) is performed depends upon the tumor stage. For an intracorporeal anastomosis, the bowel is transected proximally and distally using a linear stapler. The terminal ileum is positioned along the transverse colon in an isoperistaltic fashion. After that a colotomy and an enterotomy are made on the antimesenteric edge of the colon and small bowel respectively

Locations

Country	Name	City	State
Italy	Ospedale Generale Regionale F. Miulli	Acquaviva Delle Fonti	Bari
Italy	Ospedale Umberto I	Ancona
Italy	Ospedale Bonomo	Andria
Italy	Ospedale Regionale U. Parini	Aosta
Italy	Ospedale Santa Maria Annunziata	Bagno A Ripoli	Firenze
Italy	Policlinico Ponte San Pietro	Bergamo
Italy	ASL Biella	Biella
Italy	IRCCS AOU Bologna, Sant'Orsola	Bologna
Italy	Ospedale centrale di Bolzano	Bolzano
Italy	Ospedale San Pietro e Paolo	Borgosesia	Vercelli
Italy	Azienda Ospedaliero universitaria di Cagliari	Cagliari
Italy	PO Santissima Trinità ASL Cagliari	Cagliari
Italy	IRCCS Saverio de Bellis	Castellana Grotte	Bari
Italy	AOU Mater Domini Università Magna Grecia Catanzaro	Catanzaro
Italy	Ospedale San Paolo	Civitavecchia	Roma
Italy	Ospedale Valcamonica	Esine	Brescia
Italy	Anania Gabriele	Ferrara
Italy	AOU Careggi	Firenze
Italy	Ospedale San Giovanni di Dio	Firenze
Italy	Azienda Ospedaliero Universitaria di Foggia	Foggia
Italy	Ospedale Morgagni-Pierantoni	Forlì
Italy	Ospedale San Giovanni di Dio Frattamaggiore	Frattamaggiore	Napoli
Italy	Ospedale CTO	Iglesias	Sud Sardegna
Italy	Ospedale Carlo Urbani	Jesi	Ancona
Italy	P.O. San Salvatore	L'Aquila
Italy	Ospedale di Latisana	Latisana	Udine
Italy	Ospedale Nuovo di Legnano	Legnano	Milano
Italy	Ospedale civile di Macerata	Macerata
Italy	AO Papardo	Messina
Italy	IRCCS Ca Granada Ospedale Maggiore Policlinico Milano	Milano
Italy	Ospedale San Raffaele	Milano
Italy	AOU Modena	Modena
Italy	Ospedale San Valentino	Montebelluna	Treviso
Italy	ASST Spedali Civili	Montichiari	Brescia
Italy	AORN dei Colli - Ospedale Monaldi	Napoli
Italy	AOU Federico II di Napoli	Napoli
Italy	Isitituto Nazionale Tumori ICRSS Fondazione G. Pascale	Napoli
Italy	Policlinico San Marco Zingonia	Osio Sotto	Bergamo
Italy	Policlinico P. Giaccone	Palermo
Italy	Ospedali Riuniti Marche Nord	Pesaro
Italy	Ospedale Civile Santo Spirito	Pescara
Italy	Ospedale Immacolata Concezione Piove di Sacco ULSS 6	Piove Di Sacco	Padova
Italy	Azienda Ospedaliero Universitaria di Pisa	Pisa
Italy	Ospedale Santo Stefano	Prato
Italy	AOU Tor Vergata	Roma
Italy	Azienda Ospedaliera Sant'Andrea	Roma
Italy	Ospedale San Carlo di Nancy	Roma
Italy	Ospedale San Filippo Neri ASL Roma 1	Roma
Italy	Ospedale Sandro Pertini	Roma
Italy	Ospedale Sant'Andrea	Roma
Italy	Policlinico Campus biomedico	Roma
Italy	Ospedale Santa Maria della Misericordia	Rovigo
Italy	Azienda Ospedaliero Universitaria Sassari	Sassari
Italy	Ospedale San Paolo	Savona
Italy	Ospedale Maria Vittoria	Torino
Italy	Ospedale Martini	Torino
Italy	Piccola casa della divina provenienza Ospedale Cottolengo	Torino
Italy	Ospedale Sant'Antonio Abate	Trapani
Italy	Ospedale San Camillo	Trento
Italy	AOU Trieste	Trieste
Italy	Ospedale Sant'andrea	Vercelli
Italy	Ospedale Belcolle	Viterbo

Sponsors (1)

Lead Sponsor	Collaborator
Gabriele Anania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the analysis of lymphadenectomy in the course of right hemciolectomy, in relation to the radicality of surgical resection that is performed	In particular, the invastigators want to inquire how according to precise standards regarding surgical radicalness and consequently the anatomical piece that is obtained it is possible to correlate a certain number of lymph nodes and their possible positivity. In the study various items about lymphadenectomy will be invastigated: tumor free margin > 5cm, lenght of teminal ileum > 10cm, different level at which colic vessel are closed (proximal or distal ligation) and consequentially the different lymph nodes stations collected, mesocolic sail integrity based on Benz score, number of lymph node harvest and number of lymph nodes positive for metastatic involvement, type of surgical procedure (video-assisted, laparoscopic, robotic).	6 months
Secondary	Vascular anatomical variability	The investigators wants to study the vascular anatomical variability of the patients enrolled in the study, and how this variability may affect the extent of lymphoadenectomy. The investigators will analize the vessels anatomy with pre-operative imaging (CT scan) and with intra-operative feedback. The attention will be on the position of superior mesenteric artery relative to superior mesenteric vein (before or behind). Futhermore the invastigators wants to study the anatomical variants of the vessels: the presence of the middle colic artery and its branches, the presence of the right colic artery and their variability in percentage terms	6 months