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

Completed

• Conditions: Gastrointestinal Disease; Duodenal Neoplasm; Survival; Surgery--Complications

• Registration Number: NCT04151394
• Lead Sponsor: Universidad de Extremadura

Brief 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

Detailed 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)

Study Timeline

• Study Start: 2019-01-31
• Primary Completion: 2019-09-01
• Study Completion: 2019-10-01
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-10-31
• Status Verified: 2019-11
• Study First Posted: 2019-11-05
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication	90 days	Surgical complications rates
Overall survival	10 years	Patients overall survival after resection

Trial Locations

Locations (1)

Gerardo Blanco-Fernández; 🇪🇸 Badajoz, Spain