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

Sponsor
Universidad de Extremadura (Other)
Overall Status
Completed
CT.gov ID
NCT04151394
Collaborator
Complejo Hospitalario Universitario de Badajoz (Other)
13
1
8
1.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
13 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Side-to-side Duodenojejunostomy After Resection of Third and Fourth Duodenal Part With Pancreatic Preservation
Actual Study Start Date :
Jan 31, 2019
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Outcome Measures

Primary Outcome Measures

  1. Complication [90 days]

    Surgical complications rates

  2. Overall survival [10 years]

    Patients overall survival after resection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gerardo Blanco-Fernández Badajoz Spain 08080

Sponsors and Collaborators

  • Universidad de Extremadura
  • Complejo Hospitalario Universitario de Badajoz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gerardo Blanco-Fernández, Head of Surgery, Clinical Professor, Universidad de Extremadura
ClinicalTrials.gov Identifier:
NCT04151394
Other Study ID Numbers:
  • UE-CHUB 001-2019
First Posted:
Nov 5, 2019
Last Update Posted:
Nov 18, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2019