Side-to-side Duodenojejunostomy After Distal Duodenal Resection (DUORESECT)

Surgery--Complications Clinical Trial

— DUORESECT  

Official title:

Side-to-side Duodenojejunostomy After Resection of Third and Fourth Duodenal Part With Pancreatic Preservation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151394
• Other study ID #: UE-CHUB 001-2019
• Status: Completed
• Start date: January 31, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: November 2019
• Source: Universidad de Extremadura
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Lower partial duodenectomy could be indicated in case of injury, wide neck diverticulum, tumor invasion by other tumors such as retroperitoneal sarcoma and primary tumor of 3rd and 4th portion of the duodenum. Reconstruction after resection is usually performed by a end-to-end or end-to-side anastomosis.

The investigators analyze the short and long-term results of a case series with resection for various lesions in the third and fourth duodenal portions and reconstruction of the intestinal transit through side-to-side duodenojejunostomy

Description:

The investigators retrospectively looked at patients who, from January 2010 to December 2018, underwent surgical procedures for duodenal tumors or other type of primary lesions.

Patients with primary duodenal lesions who underwent surgery were included in the study. Patients with secondary duodenal infiltration or liver and/or peritoneal metastasis found during intraoperative exploration were excluded. Similarly, if the surgeons appreciate the involvement of the pancreas during the procedure, for which they would have to perform a pancreaticoduodenectomy, the patient would be excluded.

Diagnostic management included establishment of a medical history, performance of clinical examination and imaging tests, including endoscopic exploration and, when neoplasm was suspected, computerized tomography (CT) scan, to confirm the tumor origin and growth, as well as infiltration, if any, of adjacent structures. These also allowed to rule out distant metastases, and to assess resectability and the option for reconstruction according to the location.

The variables taken into account were age, sex, the American Society of Anesthesiologists (ASA) classification, preoperative examinations performed and type of lesion susppected as benign, duodenal adenocarcinoma or gastrointestinal stromal tumor (GIST). Perioperative clinical results, surgical approach, type of resection and reconstruction, and intraoperative complications were recorded. Details of the postoperative course were collected. Some of the key short-term data recorded included length of hospital stay, complications' ranking (according to the Clavien-Dindo score; 'severe complication' is defined as greater or equal to IIIa), re-operation, re-admission and operative mortality (< 90 days after operation). Some of the key long-term data recorded were, digestive symptoms along follow-up, specific disease-free survival (DFS) and overall survival (OS)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with primary duodenal lesions who underwent surgery

Exclusion Criteria:

• Secondary duodenal infiltration or liver and/or peritoneal metastasis found during intraoperative exploration

Related Conditions & MeSH terms

• Digestive System Diseases
• Duodenal Neoplasm
• Duodenal Neoplasms
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Surgery--Complications
• Survival

Intervention

Procedure:
• Duodenojejunostomy
Resection of duodenal lesions and reconstruction by duodenojejunostomy

Locations

Country	Name	City	State
Spain	Gerardo Blanco-Fernández	Badajoz

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Extremadura	Complejo Hospitalario Universitario de Badajoz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication	Surgical complications rates	90 days
Primary	Overall survival	Patients overall survival after resection	10 years